Page last updated: 2024-12-04

ambroxol

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Description

Ambroxol: A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID2132
CHEMBL ID153479
CHEMBL ID1477775
CHEBI ID135590
CHEBI ID92994
SCHEMBL ID423712
SCHEMBL ID18702
SCHEMBL ID7855003
SCHEMBL ID21765132
MeSH IDM0000855

Synonyms (149)

Synonym
BRD-K11223672-003-03-7
BRD-K56558538-003-02-8
DIVK1C_000027
KBIO1_000027
trans-4-{[(2-amino-3,5-dibromophenyl)methyl]amino}cyclohexanol
18683-91-5
n-(trans-4-hydroxycyclohexyl)-(2-amino-3,5-dibromobenzyl)-amine
n-(2-amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol [spanish]
trans-4-((2-amino-3,5-dibromobenzyl)amine)cyclohexanol
cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, trans-
bromhexine-metabolite viii
n-(2-amino-3,4-dibromocyclohexyl)-trans-4-aminocyclohexanol
trans-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol
ambroxol [inn:ban]
trans-4-((2-amino-3,5-dibromobencil)amino)ciclohexanol [spanish]
n-(trans-p-hydroxycyclohexyl)-(2-amino-3,5-dibromobenzyl)amine
bisolvon metabolite viii
einecs 242-500-3
n-(trans-4-hidroxiciclohexil)-(2-amino-3,5-dibromobencil)amina [spanish]
cyclohexanol, 4-((2-amino-3,5-dibromobenzyl)amino)- (e)-
ambroxolum [inn-latin]
bromhexine metabolite viii
SPECTRUM_001346
SMP1_000014
cyclohexanol, 4-[[(2-amino-3,5-dibromophenyl)methyl]amino]-, trans-
NCGC00016781-01
IDI1_000027
tabcin (tn)
ambroxol (inn)
D07442
PRESTWICK3_000366
BPBIO1_000541
BCBCMAP01_000092
SPECTRUM5_001021
PRESTWICK2_000366
AB00514663
ambroxol
4-[(2-amino-3,5-dibromo-phenyl)methylamino]cyclohexanol
cyclohexanol, 4-[[(2-amino-3,5-dibromo-phenyl)methyl]amino]-, trans
amboxol
NCGC00159399-02
OPREA1_766685
BSPBIO_000491
KBIO2_004394
KBIOSS_001826
KBIO2_006962
KBIO3_002050
KBIO2_001826
KBIOGR_001396
SPECTRUM2_001518
NINDS_000027
SPBIO_002412
PRESTWICK1_000366
PRESTWICK0_000366
SPBIO_001595
SPECTRUM3_000955
SPECTRUM4_001068
NCGC00016781-02
smr000718792
MLS001306470
CHEBI:135590
HMS2089D06
CHEMBL153479
tabcin
4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexan-1-ol
STK711075
ec 242-500-3
ambroxolum
n-(2-amino-3,4-dibromociclohexil)-trans-4-aminociclohexanol
n-(trans-4-hidroxiciclohexil)-(2-amino-3,5-dibromobencil)amina
unii-200168s0cl
trans-4-((2-amino-3,5-dibromobencil)amino)ciclohexanol
200168s0cl ,
A813089
BBL009896
trans-4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol
BCP9000283
HMS2231B19
AKOS005530704
4-{[(2-amino-3,5-dibromophenyl)methyl]amino}cyclohexan-1-ol
bdbm50395322
BCP0726000066
107814-37-9
rac-cis-ambroxol
FT-0630430
FT-0622261
AKOS015889660
36557-04-7
S5710
HMS3373J22
CHEMBL1477775
CCG-207907
SCHEMBL423712
4-((2-amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol
SCHEMBL18702
4-[(2-amino-3,5-dibromophenyl)methylamino]cyclohexanol
ambroxol base
4-[(2-amino-3,5-dibromophenyl)methylamino-]cyclohexanol
ambroxol [who-dd]
ambroxol [inn]
ambroxol [mi]
4-hydroxydemethylbromhexine, trans-
AB01275465-01
CS-4558
NCGC00016781-08
SCHEMBL7855003
JBDGDEWWOUBZPM-XYPYZODXSA-N
4-[(2-amino-3,5-dibromobenzyl)amino]cyclohexanol, trans-
HY-B1039
AB00053639_13
DTXSID8022583 ,
cis-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol
mfcd00242702
AKOS027338704
AC-8362
(1s,4s)-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexanol
CHEBI:92994
mfcd28143339
SR-05000001463-1
(1r,4r)-4-((2-amino-3,5-dibromobenzyl)amino)cyclohexan-1-ol
SBI-0051766.P002
NCGC00371077-02
DB06742
SCHEMBL21765132
FT-0661549
BCP04489
1217679-83-8
VS-02240
Q221637
BRD-K11223672-003-04-5
SB17463
HMS3886M18
ambroxol hydrochloride impurity d [ep]
unii-qh6zt6j071
AS-56023
gtpl10692
cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, trans- (9ci)
cis-4-(((2-amino-3,5-dibromophenyl)methyl)amino)cyclohexanol
QH6ZT6J071 ,
cyclohexanol, 4-(((2-amino-3,5-dibromophenyl)methyl)amino)-, cis-
4-hydroxydemethylbromhexine, cis-
ambroxol hydrochloride impurity d [ep impurity]
ambroxol, cis-
SB82866
cis-ambroxol
DTXSID60860228
EN300-18524079
(1r,4r)-4-{[(2-amino-3,5-dibromophenyl)methyl]amino}cyclohexan-1-ol
CS-0323348

Research Excerpts

Overview

Ambroxol is a multifaceted drug with primarily mucoactive and secretolytic actions, along with anti-inflammatory, antioxidant, and local anaesthetic properties. Ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine.

ExcerptReferenceRelevance
"Ambroxol (ABX) is a mucolytic agent used for the treatment of respiratory diseases. "( Mechanistic Insight into the Mode of Action of Acid β-Glucosidase Enhancer Ambroxol.
Cubellis, MV; Hermann, A; Hules, L; Lukas, J; Monticelli, M; Pantoom, S; Petrosyan, A; Pospech, J; Schöll, C, 2022
)
2.39
"Ambroxol is a multifaceted drug with primarily mucoactive and secretolytic actions, along with anti-inflammatory, antioxidant, and local anaesthetic properties. "( Ambroxol for neuropathic pain: hiding in plain sight?
Baron, R; Dickenson, AH; Kern, KU; Russo, MA; Santarelli, DM, 2023
)
3.8
"Ambroxol (AMB) is a member of the expectorant class, widely used as a secreolytic agent in patients to break up secretions. "( A brief review on critical analytical aspects for quantification of ambroxol in biological samples.
Chaudhari, SR; Ganorkar, SB; Patil, AS; Shirkhedkar, AA; Sonawane, PD, 2022
)
2.4
"Ambroxol hydrochloride is an oral mucolytic drug available over-the-counter for many years as cough medicine. "( Upgrading the evidence for the use of ambroxol in Gaucher disease and GBA related Parkinson: Investigator initiated registry based on real life data.
Al-Hertani, W; Becker-Cohen, M; Castillo-Garcia, D; Ceron-Rodriguez, M; Chan, A; Dinur, T; Fiumara, A; Istaiti, M; Kiec-Wilk, B; Lee, BH; Ramaswami, U; Revel-Vilk, S; Rodic, P; Rubio, B; Tincheva, RS; Yang, CF; Zimran, A, 2021
)
2.34
"Ambroxol (AMB) is a drug commonly used for chronic bronchitis prevention. "( High efficiency photocatalytic degradation of Ambroxol over Mn doped TiO
Belabed, C; Bellal, B; Dahmane, M; Richard, C; Tab, A; Trari, M, 2021
)
2.32
"Ambroxol is a secretolytic agent used in the treatment of various airway disorders."( Ambroxol for fibromyalgia: one group pretest-posttest open-label pilot study.
Acosta, G; Barrera-Villalpando, MI; Becerril-Mendoza, LT; Martínez-Lavín, M; Martínez-Martínez, LA; Muñoz, OE; Pérez, LF; Rodríguez-Henriquez, P; Silveira, LH; Vargas, A, 2017
)
2.62
"Ambroxol is a muco-active agent with multiple, clinically relevant effects in the airway. "( In vitro pharmacology of ambroxol: Potential serotonergic sites of action.
Hull, JD; Lyon, RA, 2018
)
2.23
"Ambroxol (Mucosolvan®) is a mucolytic and secretolytic drug and belongs to the group of expectorants with anti-oxidative and anti-inflammatory effects."( Effects and mechanisms of ambroxol inhalation (Mucosolvan
Chen, S; He, X; Huang, Y; Lin, Z; Lu, Q; Xiao, X; Yang, Z, 2017
)
1.48
"Ambroxol is a widely used secretolytic and mucoactive over-the-counter agent primarily used to treat respiratory diseases associated with viscid mucus. "( Safety of ambroxol in the treatment of airway diseases in adult patients.
Cazan, D; Klimek, L; Kölsch, S; Plomer, M; Sperl, A, 2018
)
2.33
"Ambroxol is a pharmacological chaperone for GCase and is able to raise the levels of GCase and could therefore be a disease-modifying treatment for PDD."( Ambroxol as a novel disease-modifying treatment for Parkinson's disease dementia: protocol for a single-centre, randomized, double-blind, placebo-controlled trial.
Bartha, R; Borrie, M; Coleman, K; Finger, E; Hegele, RA; Jenkins, ME; Jog, M; Li, Z; MacDonald, P; MacKinley, J; Mahuran, D; Morrow, SA; Pasternak, SH; Rupar, CA; Silveira, CRA; Tirona, RG; Wells, J; Zou, G, 2019
)
2.68
"Ambroxol (AMB) is a mucoactive drug that has been used for numerous respiratory diseases."( Uroprotective effect of ambroxol in cyclophosphamide-induced cystitis in mice.
Barut, B; Barut, EN; Engin, S; Kadioglu, M; Kaya, C; Kerimoglu, G; Ozel, A, 2019
)
1.54
"Ambroxol is a pharmacological chaperone (PC) for Gaucher disease that increases lysosomal activity of misfolded β-glucocerebrosidase (GCase) while displaying a safe toxicological profile. "( Scaffolds for Sustained Release of Ambroxol Hydrochloride, a Pharmacological Chaperone That Increases the Activity of Misfolded β-Glucocerebrosidase.
Alemán, C; Arnan, C; Del Valle, LJ; Enshaei, H; Estrany, F; Molina, BG; Puiggalí, J; Saperas, N, 2019
)
2.23
"Ambroxol is a safe option for individual patients with mainly local symptoms asking for treatment."( Efficacy of Ambroxol lozenges for pharyngitis: a meta-analysis.
Chenot, JF; Friede, T; Weber, P, 2014
)
1.5
"Ambroxol (Ax) is a frequently prescribed drug used to facilitate mucociliary clearance, but its mode of action is yet poorly understood. "( A new role for an old drug: Ambroxol triggers lysosomal exocytosis via pH-dependent Ca²⁺ release from acidic Ca²⁺ stores.
Dietl, P; Felder, E; Fois, G; Haller, T; Hobi, N; Miklavc, P; Radermacher, P; Walther, P; Ziegler, A, 2015
)
2.15
"Ambroxol acts as a strong local anaesthetic and preferentially inhibits the nociceptively relevant sodium channel subtype Nav 1.8. "( Topical ambroxol for the treatment of neuropathic pain. An initial clinical observation.
Kern, KU; Weiser, T, 2015
)
2.29
"Ambroxol acts as a strong local anesthetic and preferentially inhibits the nociceptive-relevant sodium channel subtype Nav 1.8. "( [Topical ambroxol for the treatment of neuropathic pain: A first clinical observation. German version].
Kern, KU; Weiser, T, 2015
)
2.28
"Ambroxol is a small molecule chaperone that has been shown to increase glucocerebrosidase activity in vitro."( Ambroxol effects in glucocerebrosidase and α-synuclein transgenic mice.
Bezard, E; Daly, L; Migdalska-Richards, A; Schapira, AH, 2016
)
2.6
"Ambroxol is a small molecule chaperone that has been shown in mice to cross the blood-brain barrier, increase GCase activity and reduce alpha-synuclein protein levels."( Oral ambroxol increases brain glucocerebrosidase activity in a nonhuman primate.
Bezard, E; Ko, WKD; Li, Q; Migdalska-Richards, A; Schapira, AHV, 2017
)
1.69
"Ambroxol is a widely used secretolytic agent originally developed from vasicine, a natural alkaloid found in Adhatoda vasica, extracts of which have been used to treat bronchitis, asthma, and rheumatism. "( Differential modulation of IgE-dependent activation of human basophils by ambroxol and related secretolytic analogues.
Gibbs, BF,
)
1.8
"Ambroxol is an expectoration improver and mucolytic agent that has been used to treat acute and chronic disorders. "( Development of the ambroxol gels for enhanced transdermal delivery.
Cho, CW; Choi, JS; Shin, SC, 2008
)
2.12
"Ambroxol was found to be a sufficient scavenger of HClO and .OH and also revealed the capacity to decompose H2O2."( Antioxidant properties of Ambroxol.
Antczak, A; Bialasiewicz, P; Król, M; Nowak, D; Pietras, T, 1994
)
1.31
"Ambroxol is a mucus-modifying drug with a known ability to stimulate surfactant secretion and inhibit, in vitro, the production of proinflammatory cytokines, neutrophil chemotaxis, and Na+ absorption by the airway epithelium. "( Intraluminal inflammation in the airways of patients with chronic bronchitis after treatment with Ambroxol.
Capelli, A; Cerutti, CG; Donner, CF; Lusuardi, M; Salmona, M; Tacconi, MT, 1995
)
1.95
"Ambroxol is a mucolytic agent frequently used in the treatment of chronic bronchitis. "( Reduction of cytokine release of blood and bronchoalveolar mononuclear cells by ambroxol.
Kienast, K; Müller-Quernheim, J; Pfeifer, S; Zissel, G, 1997
)
1.97
"Ambroxol is a mucolytic agent which is widely used in chronic bronchitis in Europe. "( A controlled trial of ambroxol in chronic bronchitis.
Guyatt, GH; Kazim, F; Newhouse, MT; Townsend, M, 1987
)
2.03
"Ambroxol is a new compound which increases secretion of phosphatidylcholine by type II pneumocytes. "( Ambroxol decreases bronchial hyperreactivity.
Cocco, G; Melillo, G, 1986
)
3.16

Effects

Ambroxol has a long history for the treatment of airway diseases because of its beneficial effects on surfactant synthesis and mucus-modifying properties. Ambroxol has an obvious protective effect on VILI through its antioxidant/anti-inflammation potent.

Ambroxol has a long history for the treatment of airway diseases because of its beneficial effects on surfactant synthesis and mucus-modifying properties. It has been shown to change the airway secretions of patients affected by chronic bronchitis.

ExcerptReferenceRelevance
"Ambroxol has a proven antiviral effect and a unique stimulatory action on the secretion of surfactant by alveolar type II cells, the main target of SARS-CoV-2."( Azithromycin and ambroxol as potential pharmacotherapy for SARS-CoV-2.
Alkotaji, M, 2020
)
1.62
"Ambroxol has a local anaesthetic action and is marketed for pain relief for sore throat. "( Efficacy of Ambroxol lozenges for pharyngitis: a meta-analysis.
Chenot, JF; Friede, T; Weber, P, 2014
)
2.22
"Ambroxol also has a protective effect on the lungs during extracorporeal bypass, ameliorating inflammatory reaction and oxygen stress and preserving pulmonary surfactant."( Does ambroxol confer a protective effect on the lungs in patients undergoing cardiac surgery or having lung resection?
Chen, X; Huang, D; Ma, Q; Wang, S, 2014
)
1.64
"Ambroxol has a very high affinity for lung tissues; its concentration is approximately 20 times higher in the lung than in the serum. "( High-dose ambroxol reduces pulmonary complications in patients with acute cervical spinal cord injury after surgery.
Li, Q; Yao, G; Zhu, X, 2012
)
2.22
"Ambroxol has a long history for the treatment of airway diseases because of its beneficial effects on surfactant synthesis and mucus-modifying properties. "( Inhibition of tetrodotoxin (TTX)-resistant and TTX-sensitive neuronal Na(+) channels by the secretolytic ambroxol.
Weiser, T; Wilson, N, 2002
)
1.97
"Ambroxol has an obvious protective effect on VILI through its antioxidant/anti-inflammation potent."( [Prophylaxis against ventilator-induced lung injury by Ambroxol].
Liu, Y; Zhang, B, 2000
)
1.28
"Ambroxol (ABX) has been suggested as an augmentative pharmacological agent for neuronopathic Gaucher disease (nGD). "( Pharmacologic properties of high-dose ambroxol in four patients with Gaucher disease and myoclonic epilepsy.
Bae, JS; Cozma, C; Heo, SH; Jin, HK; Kim, HW; Kim, T; Kim, YM; Ko, TS; Lee, BH; Lim, HS; Lim, HT; Oh, A; Osborn, MJ; Rolfs, A; Seo, GH; Tolar, J; Yoo, HW; Yoon, HM; Yum, MS; Zimran, A, 2020
)
2.27
"Ambroxol has a proven antiviral effect and a unique stimulatory action on the secretion of surfactant by alveolar type II cells, the main target of SARS-CoV-2."( Azithromycin and ambroxol as potential pharmacotherapy for SARS-CoV-2.
Alkotaji, M, 2020
)
1.62
"Ambroxol has been suggested as an enzyme enhancement agent."( Early initiation of ambroxol treatment diminishes neurological manifestations of type 3 Gaucher disease: A long-term outcome of two siblings.
Barić, I; Bogdanić, A; Bošnjak-Nađ, K; Fumić, K; Mustać, G; Ohno, K; Ozretić, D; Ramadža, DP; Škaričić, A; Zekušić, M; Žigman, T, 2021
)
1.67
"Ambroxol has been established for decades in the treatment of acute and chronic respiratory diseases. "( [More than expectorant: new scientific data on ambroxol in the context of the treatment of bronchopulmonary diseases].
de Zeeuw, J; Plomer, M, 2017
)
2.15
"Ambroxol has a local anaesthetic action and is marketed for pain relief for sore throat. "( Efficacy of Ambroxol lozenges for pharyngitis: a meta-analysis.
Chenot, JF; Friede, T; Weber, P, 2014
)
2.22
"Ambroxol also has a protective effect on the lungs during extracorporeal bypass, ameliorating inflammatory reaction and oxygen stress and preserving pulmonary surfactant."( Does ambroxol confer a protective effect on the lungs in patients undergoing cardiac surgery or having lung resection?
Chen, X; Huang, D; Ma, Q; Wang, S, 2014
)
1.64
"Ambroxol has been studied as a potential agent to prevent RDS, but effectiveness and safety has yet to be evaluated."( Ambroxol for women at risk of preterm birth for preventing neonatal respiratory distress syndrome.
Gonzalez Garay, AG; Reveiz, L; Solis Galicia, C; Velasco Hidalgo, L, 2014
)
2.57
"Ambroxol has previously demonstrated antinociceptive effects in rat chronic pain models and has also shown to potently block Na(+) channel current in DRG neurons."( Antinociceptive effect of ambroxol in rats with neuropathic spinal cord injury pain.
Hama, AT; Plum, AW; Sagen, J, 2010
)
1.38
"Ambroxol has a very high affinity for lung tissues; its concentration is approximately 20 times higher in the lung than in the serum. "( High-dose ambroxol reduces pulmonary complications in patients with acute cervical spinal cord injury after surgery.
Li, Q; Yao, G; Zhu, X, 2012
)
2.22
"Ambroxol has a long history for the treatment of airway diseases because of its beneficial effects on surfactant synthesis and mucus-modifying properties. "( Inhibition of tetrodotoxin (TTX)-resistant and TTX-sensitive neuronal Na(+) channels by the secretolytic ambroxol.
Weiser, T; Wilson, N, 2002
)
1.97
"Ambroxol has obviously therapeutic effect on paraquat poisoning."( [Effects of high dose ambroxol on lung injury induced by paraquat in rats].
Liu, JH; Lv, CH; Ma, YT; Shi, HW; Sun, ZP; Tian, YP, 2007
)
1.38
"Ambroxol which also has anti-oxidative and anti-inflammatory effects does not exhibit direct stimulatory effects on surfactant synthesis and secretion in isolated (rat) alveolar type II cells as has been demonstrated e.g."( [Effect of ambroxol on surfactant secretion and synthesis in isolated type II alveolar cells].
Wirtz, HR, 2000
)
1.42
"Ambroxol has an obvious protective effect on VILI through its antioxidant/anti-inflammation potent."( [Prophylaxis against ventilator-induced lung injury by Ambroxol].
Liu, Y; Zhang, B, 2000
)
1.28
"Ambroxol has been determined in biological fluids using a rapid and sensitive high-performance liquid chromatographic method. "( High-performance liquid chromatographic determination of ambroxol in human plasma.
Kvêtina, J; Macek, K; Nobilis, M; Pastera, J; Svoboda, D, 1992
)
1.97
"Ambroxol has been well tolerated."( [Value of ambroxol in treatment of bronchial asthma and spastic bronchitis].
Obrzut, D; Rogalewska, A; Siergiejko, Z,
)
1.26
"Ambroxol has been shown to significantly reduce RDS compared to placebo without causing important adverse effects in either mother or baby."( Prevention and treatment of fetal lung immaturity.
Cosmi, EV; Di Renzo, GC, 1989
)
1
"Ambroxol hydrochloride has been shown to protect the lung from damage by polymorphonuclear leucocyte (PMN). "( Effect of ambroxol of neutrophil chemotaxis in vitro.
Burnett, D; Shaw, J; Stockley, RA, 1988
)
2.12
"Ambroxol has previously been shown to change the airway secretions of patients affected by chronic bronchitis; these secretions significantly improved mucociliary transport when applied to the frog palate."( Influence of surfactant on mucociliary transport.
Allegra, L; Bossi, R; Braga, P, 1985
)
0.99

Actions

Ambroxol can inhibit lipid peroxidation and increase antioxidant activity, which may be one of the mechanisms in protecting lung tissue from hydrochloric acid-induced injury. Ambroxol did not cause any significant maternal or infant side effects.

ExcerptReferenceRelevance
"Ambroxol could destroy the biofilm of Haemophilus influenzae, and had bactericidal function in vitro."( [Effect of ambroxol on biofilm of Haemophilus influenzae and bactericidal action].
Gao, X; Li, H; Lin, Y; Shang, X; Xin, Y; Xu, Y; Zhang, X; Zhang, Y, 2014
)
2.23
"Ambroxol can inhibit lipid peroxidation and increase antioxidant activity, which may be one of the mechanisms in protecting lung tissue from hydrochloric acid-induced injury."( [Oxidative and anti-oxidative effects of ambroxol on acute hydrochloric acid-induced lung injury in rats].
Guo, QL; Wang, E; Wang, RK; Zhao, SP, 2004
)
2.03
"Ambroxol can suppress reflexes such as the cough or the corneal reflex which are connected to stimulation of C fibre endings."( The influence of ambroxol and capsaicin on the isolated rabbit bladder wall.
Drewa, T; Kaczorowski, P; Krawczyk, A; Młodzik-Danielewicz, N; Pokrywka, L; Tyrakowski, T; Wolski, Z,
)
1.19
"Ambroxol plays a role in facilitating synthesis and secretion of pulmonary surfactant protein A and relieves the lung tissue injury induced by paraquat poisoning."( [Influence of ambroxol on paraquat-induced lung tissue injury and change of pulmonary surfactant-associated protein A in the experimental rats].
Feng, L; Liu, JH; Lv, CH; Ma, YT; Shi, HW; Su, JL; Sun, ZP; Tian, YP, 2006
)
2.14
"Ambroxol did not cause any significant maternal or infant side effects."( Antenatal ambroxol usage in the prevention of infant respiratory distress syndrome. Beneficial and adverse effects.
Kimya, Y; Küçükkömürcü, S; Ozan, H; Uncu, G, 1995
)
1.31
"Ambroxol does not increase ofloxacin concentrations in bronchial tissue because high concentrations are already present in the lung."( Evaluation of the effects of ambroxol on the ofloxacin concentrations in bronchial tissues in COPD patients with infectious exacerbation.
Bouvet, O; Bressolle, F; Chanez, P; Fabre, D; Galtier, M; Godard, P; Michel, FB; Paganin, F, 1995
)
1.3
"Ambroxol is able to inhibit mediator release involved in the pathogenesis of allergic inflammation."( [Mucolytics in acute and chronic respiratory tract disorders. II. Uses for treatment and antioxidant properties].
Kuna, P; Kupczyk, M, 2002
)
1.04

Treatment

Ambroxol significantly reduced HexSph concentration in GD (by 2.1-fold) and GBA-PD patients (by 1.6-fold). Ambroxol treatment resulted in increased brain glucocerebrosidase activity in mice.

ExcerptReferenceRelevance
"Ambroxol treatment significantly reduced HexSph concentration in GD (by 2.1-fold) and GBA-PD patients (by 1.6-fold) (p < 0.0001 and p < 0.0001, respectively)."( Ambroxol increases glucocerebrosidase (GCase) activity and restores GCase translocation in primary patient-derived macrophages in Gaucher disease and Parkinsonism.
Baydakova, GV; Bezrukikh, VA; Bogdanova, DA; Bolshakova, OI; Cheblokov, AA; Emelyanov, AK; Kopytova, AE; Miliukhina, IV; Nikolaev, MA; Pchelina, SN; Rychkov, GN; Salogub, GN; Sarantseva, SV; Senkevich, KA; Usenko, TC; Zakharova, EY, 2021
)
2.79
"Ambroxol treatment resulted in increased brain glucocerebrosidase activity in (1) wild-type mice, (2) transgenic mice expressing the heterozygous L444P mutation in the murine glucocerebrosidase 1 gene, and (3) transgenic mice overexpressing human α-synuclein. "( Ambroxol effects in glucocerebrosidase and α-synuclein transgenic mice.
Bezard, E; Daly, L; Migdalska-Richards, A; Schapira, AH, 2016
)
3.32
"Ambroxol treatment reduced biofilm thickness, increased areal porosity, and decreased the average diffusion distance and textual entropy of wild-type and double-mutant strains."( Ambroxol interferes with Pseudomonas aeruginosa quorum sensing.
Lin, L; Lin, Y; Lu, Q; Wang, J; Wang, L; Yang, X; Yu, J, 2010
)
2.52
"The ambroxol-treated group had lower risk of neonatal infection than the corticosteroid-treated group (RR = 0.36, 95% CI: 0.18 to 0.73)."( Prevention of respiratory distress syndrome in preterm infants by antenatal ambroxol: a meta-analysis of randomized controlled trials.
Huang, XM; Lu, H; Wu, QQ; Zhang, ZQ, 2013
)
1.1
"Ambroxol parenteral treatment caused xanthine and oxalate stone formation. "( Parenteral ambroxol treatment causes xanthine and calcium oxalate stones in rats.
Drewa, J; Drewa, T; Mikulska-Jovanovic, M; Misterek, B; Pachnowska, H; Wolski, Z, 2007
)
2.17
"Ambroxol treatment group consisted of 39 subjects in whom 1,000 mg of ambroxol diluted in 500 ml of 5% glucose solution was given intravenously for 4 hours once a day for 3 days, while the control group consisted of 41 subjects in whom ambroxol was not administered."( Antenatal use of ambroxol for the prevention of infant respiratory distress syndrome.
Fernandez, AM; Laoag-Fernandez, JB; Maruo, T, 2000
)
1.37
"In Ambroxol-treated animals the statistically significant increase in the antioxidant enzyme activity was noted while the intensity of peroxidative processes was found to be lower."( The influence of Ambroxol on peroxidative processes in lung and plasma in dogs after pulmonectomy.
Jabłonka, A; Jabłonka, S; Kadziołka, W; Ledwozyw, A; Nestorowicz, A, 1992
)
1.14
"Ambroxol treatments tended to increase lung volumes as evaluated by pressure-volume curves."( Antenatal ambroxol effects on surfactant pool size and postnatal lung function in preterm ventilated rabbits.
Ikegami, M; Jobe, A; Rider, E; Sun, B, 1992
)
1.41
"Treatment with ambroxol hydrochloride increased glucosylceramidase activity in fibroblasts from healthy controls, Gaucher disease and heterozygous glucocerebrosidase mutation carriers with and without Parkinson's disease."( Ambroxol improves lysosomal biochemistry in glucocerebrosidase mutation-linked Parkinson disease cells.
Abramov, AY; Chau, KY; Cooper, JM; Foltynie, T; Gegg, M; Hughes, D; Magalhaes, J; McNeill, A; Mehta, A; Schapira, AH; Shen, C, 2014
)
2.18
"Treatment with ambroxol lozenges was statistically significantly superior to placebo in reducing sore throat pain intensity with a high level of consistency of the estimated effect across the different studies."( Efficacy and safety of ambroxol lozenges in the treatment of acute uncomplicated sore throat. EBM-based clinical documentation.
Bubeck, J; de Mey, C; Kölsch, S; Peil, H; Vix, JM, 2008
)
1
"Pretreatment with ambroxol, at doses of 10, 30, 100 and 300mg/kg, p.o., dose-dependently and significantly reduced the number of fenvalerate (3μg/ml)-induced coughs."( Possible involvement of tetrodotoxin-resistant sodium channels in cough reflex.
Asato, M; Hayashi, SS; Ishikawa, Y; Kamei, J; Nakanishi, Y; Ohsawa, M, 2011
)
0.69
"Treatment with ambroxol, but not carbocisteine, significantly reduced the median number of AURD episodes (P=0.0049 vs."( Ambroxol for the prevention of acute upper respiratory disease.
Fujimura, M; Ishiura, Y; Myou, S; Nakao, S; Nobata, K, 2006
)
2.12
"Treatment with ambroxol (35 mg/kg) could influence the status of oxidative stress in lung and alleviate lung injury induced by paraquat. "( [Effects of high dose ambroxol on lung injury induced by paraquat in rats].
Liu, JH; Lv, CH; Ma, YT; Shi, HW; Sun, ZP; Tian, YP, 2007
)
1.01
"Treatment with Ambroxol significantly increased the lecithin content of BAL fluid and significantly decreased the macrophage plasma membrane microviscosity."( In vivo studies of rat alveolar macrophage [corrected] microviscosity: influence of pulmonary surfactant synthesis stimulation.
Genghini, M; Luisetti, M; Masturzo, P; Pozzi, E; Salmona, M; Spialtini, L, 1987
)
0.61
"Treatment was ambroxol, a drug that changes the bronchial secretions and promotes surfactant synthesis."( Multicenter study on the treatment of secretory otitis media with ambroxol. Importance of a surface-tension-lowering substance.
Passàli, D; Zavattini, G, 1987
)
0.86

Toxicity

ExcerptReferenceRelevance
"5%) reported a total of 81 adverse events (AE) which were usually mild in nature and mostly affecting the gastrointestinal tract (n = 53) followed by skin and subcutaneous tissue disorders (n = 9)."( Safety and usage pattern of an over-the-counter ambroxol cough syrup: a community pharmacy-based cohort study.
Gillissen, A; Hämmerlein, A; Hinkel, U; Schulz, M; Weis, G, 2006
)
0.59
" Such inappropriate use of antibiotics might best be challenged by offering efficacious and safe symptomatic pain relief instead."( Efficacy and safety of ambroxol lozenges in the treatment of acute uncomplicated sore throat. EBM-based clinical documentation.
Bubeck, J; de Mey, C; Kölsch, S; Peil, H; Vix, JM, 2008
)
0.66
" No serious adverse effect was observed during this experiment."( The chaperone activity and toxicity of ambroxol on Gaucher cells and normal mice.
Higaki, K; Li, L; Luan, Z; Nanba, E; Ohno, K; Suzuki, Y, 2013
)
0.66
" Moreover, the data on adverse events were collected."( [Efficacy and safety of acute bronchitis treatment in adults--a comparison of Bronchosol® syrup and synthetic preparations with ambroxol. Results of observational study].
Fal, AM; Schönknecht, K, 2015
)
0.62
"Bronchosol® syrup is an efficient, well-tolerated, and safe drug."( [Efficacy and safety of acute bronchitis treatment in adults--a comparison of Bronchosol® syrup and synthetic preparations with ambroxol. Results of observational study].
Fal, AM; Schönknecht, K, 2015
)
0.62
"AXL20-treatment was well tolerated and is safe and efficacious for acute uncomplicated sore throat of recent onset in adolescent and adult patients."( Efficacy and Safety of Ambroxol Lozenges in the Treatment of Acute Uncomplicated Sore Throat - a Pooled Analysis.
de Mey, C; Koelsch, S; Pohlmann, T; Richter, E; Sousa, R, 2016
)
0.74
" Following post-marketing reports of hypersensitivity reactions and severe cutaneous adverse reactions (SCARs) possibly linked to ambroxol, the European Union's Pharmacovigilance Risk Assessment Committee (PRAC) initiated in April 2014 a review of the safety of ambroxol in all its registered indications, which was finalized in 2016."( Safety of ambroxol in the treatment of airway diseases in adult patients.
Cazan, D; Klimek, L; Kölsch, S; Plomer, M; Sperl, A, 2018
)
1.09

Pharmacokinetics

No significant differences were observed for the major pharmacokinetic parameters such as C(max), T( max), t(1/2) and AUC of roxithromycin and ambroxol HCl between different treatments.

ExcerptReferenceRelevance
"A method is described which makes the detection of alterations in the pharmacokinetic profile possible when substances are administered during long-term toxicity tests."( Pharmacokinetics as an aid in the interpretation of toxicity tests.
Boxler, G; Hammer, R, 1977
)
0.26
" Elimination half-life of radioactivity in the blood was estimated as 20--25 h in rat, dog and man and as 2 h only in rabbit."( [Ambroxol, comparative studies of pharmacokinetics and biotransformation in rat, rabbit, dog and man (author's transl)].
Bozler, G; Hadamovsky, H; Hammer, R; Jauch, R; Koss, FW, 1978
)
1.17
" Pharmacokinetic parameters were calculated by non-compartmental methods and submitted to statistical comparisons."( Steady-state bioavailability and pharmacokinetics of ambroxol and clenbuterol administered alone and combined in a new oral formulation.
Acerbi, D; Bizouard, J; Chiesi, P; Couet, W; Fourtillan, JB; Girault, J; Ingrand, I; Reigner, BG, 1989
)
0.53
" Thus a stimulation of the mucociliary transport rate by the other major pharmacodynamic mechanisms, secretagogue activity and stimulation of pulmonary surfactant, has to be considered."( Pharmacodynamic mechanism and therapeutic activity of ambroxol in animal experiments.
Disse, BG; Ziegler, HW, 1987
)
0.52
" A 2-compartment model was taken as a basis for the calculation of the plasma concentration curves and the pharmacokinetic parameters following intravenous injection of the drug."( [The pharmacokinetics and bioequivalence of various dosage forms of ambroxol].
Bishop-Freudling, GB; Matzkies, F; Miczka, M; Nitsche, V; Strobel, K; Vergin, H, 1985
)
0.5
"This study determined the pharmacokinetic profile of single-dose loratadine-ambroxol hydrochloride combination therapy versus each component given separately."( Pharmacokinetic properties of single-dose loratadine and ambroxol alone and combined in tablet formulations in healthy men.
Alcántar, F; Herrera, J; Morales, JM; Rodríguez, JM; Rosete, R; Villacampa, J, 2003
)
0.79
"Although roxithromycin and ambroxol HCl were often administered concomitantly for the treatment of respiratory infections, the pharmacokinetic interactions between them have not been reported."( Simultaneous determination and pharmacokinetic study of roxithromycin and ambroxol hydrochloride in human plasma by LC-MS/MS.
Hang, TJ; Shen, JP; Song, M; Zhang, M; Zhang, YD, 2007
)
0.87
"No significant differences were observed for the major pharmacokinetic parameters such as C(max), T(max), t(1/2) and AUC of both roxithromycin and ambroxol HCl between different treatments."( Simultaneous determination and pharmacokinetic study of roxithromycin and ambroxol hydrochloride in human plasma by LC-MS/MS.
Hang, TJ; Shen, JP; Song, M; Zhang, M; Zhang, YD, 2007
)
0.77
" Therefore, there are no obvious pharmacokinetic interactions between roxithromycin and ambroxol HCl after oral administration."( Simultaneous determination and pharmacokinetic study of roxithromycin and ambroxol hydrochloride in human plasma by LC-MS/MS.
Hang, TJ; Shen, JP; Song, M; Zhang, M; Zhang, YD, 2007
)
0.79
" The method has been validated and applied to pharmacokinetic studies of compound amoxicillin and ambroxol hydrochloride tablets in healthy Chinese volunteers."( Simultaneous determination of amoxicillin and ambroxol in human plasma by LC-MS/MS: validation and application to pharmacokinetic study.
Chen, S; Ding, L; Hang, T; Tian, Y; Wang, Z; Wen, A; Xu, X; Zhang, M, 2008
)
0.82
" It was showed in result of in vivo study that tmax and Cmax of self-made capsules were significantly lower than that of market capsules and self-made tablets."( [Optimization of a floating osmotic pump system of ambroxol hydrochloride using central composite design-response surface methodology and its pharmacokinetics in Beagle dogs].
Cao, DY; Jin, XL; Ma, YL; Wang, J; Zhao, F, 2011
)
0.62
"To compare the pharmacokinetic properties of two newly developed generic ambroxol formulations with a branded innovator product in healthy Chinese male volunteers."( Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.
Chen, JL; Jiang, B; Lou, HG; Ruan, ZR; Shen, HH; Yu, LY, 2014
)
0.87
" A non-compartmental method was employed to determine pharmacokinetic properties (C(max), t(max), AUC(0-tlast), AUC(0-∞)) to test for bioequivalence."( Pharmacokinetics and bioequivalence study of three oral formulations of ambroxol 30 mg: a randomized, three-period crossover comparison in healthy volunteers.
Chen, JL; Jiang, B; Lou, HG; Ruan, ZR; Shen, HH; Yu, LY, 2014
)
0.63
" This fully validated method was successfully applied to a pharmacokinetic study of ambroxol in humans after oral administration of ambroxol at a single dose of 75 mg."( Quantitative Detection of Ambroxol in Human Plasma Using HPLC-APCI-MS/MS: Application to a Pharmacokinetic Study.
DI, X; Liu, Y; Ma, D; Mao, Z; Wang, X; Zang, Y, 2017
)
0.98

Compound-Compound Interactions

Ambroxol combined with low-dose heparin can reduce lung cells oxidative stress to inhibit the release of IL-1beta and TNF-alpha, which play a role in the treatment of ALI. High-dose ambroxol hydrochloride combined with fiberoptic bronchoscopy is beneficial to improve the patient's blood gas indicators.

ExcerptReferenceRelevance
"It was investigated whether the botanical drug combination Sinupret is able to modulate the resistance of mice to a respiratory tract infection with Sendai virus (Parainfluenza viridae) if given prophylactically to the animals."( Enhanced resistance to Sendai virus infection in DBA/2J mice with a botanical drug combination (Sinupret).
März, RW; Ottendorfer, D; Schmolz, M; Sieder, C, 2001
)
0.31
"To investigate the intervention and mechanism of ambroxol combined with low-dose heparin on oxidative stress, TNF-alpha and IL-1beta in rabbits with acute lung injury (ALI)."( [Effects of ambroxol combined with low-dose heparin on TNF-alpha and IL-1beta in rabbits with acute lung injury].
Dai, YY; Jin, KK; Pan, Z; Wang, FY; Wang, WT; Wang, Y; Xu, HJ, 2011
)
1
" Ambroxol combined with low-dose heparin can reduce lung cells oxidative stress to inhibit the release of IL-1beta and TNF-alpha, which play a role in the treatment of ALI."( [Effects of ambroxol combined with low-dose heparin on TNF-alpha and IL-1beta in rabbits with acute lung injury].
Dai, YY; Jin, KK; Pan, Z; Wang, FY; Wang, WT; Wang, Y; Xu, HJ, 2011
)
1.66
"This paper aimed to discuss the method, effect and safety of oxygen-driving and atomized Mucosolvan inhalation combined with holistic nursing in the treatment of children severe bronchial pneumonia."( Oxygen-driving and atomized mucosolvan inhalation combined with holistic nursing in the treatment of children severe bronchial pneumonia.
Yang, F, 2015
)
0.42
"The aims of the study were to investigate the potential drug-drug interaction between salbutamol and ambroxol, the bioequivalence of the new fixed-dose combination containing salbutamol and ambroxol compared with co-administration of the two separate formulations, and to describe the safety and tolerability of the fixed-dose combination formulation in healthy Chinese volunteers."( Investigation of a potential drug-drug interaction between salbutamol and ambroxol and bioequivalence of a new fixed-dose combination containing these two drugs in healthy Chinese subjects.
Ding, L; Li, T; Liu, L; Lu, J; Shi, X; Wang, Y; Yang, W; Zhao, S, 2018
)
0.93
"An open-label, single-dose, four-treatment, four-period crossover study for evaluation of drug-drug interaction and bioequivalence (n = 24) was performed."( Investigation of a potential drug-drug interaction between salbutamol and ambroxol and bioequivalence of a new fixed-dose combination containing these two drugs in healthy Chinese subjects.
Ding, L; Li, T; Liu, L; Lu, J; Shi, X; Wang, Y; Yang, W; Zhao, S, 2018
)
0.71
"There were no significant drug-drug pharmacokinetic interactions between salbutamol and ambroxol after oral administration."( Investigation of a potential drug-drug interaction between salbutamol and ambroxol and bioequivalence of a new fixed-dose combination containing these two drugs in healthy Chinese subjects.
Ding, L; Li, T; Liu, L; Lu, J; Shi, X; Wang, Y; Yang, W; Zhao, S, 2018
)
0.93
" SIGNIFICANCE AND IMPACT OF THE STUDY: Drug combination is an effective approach for the treatment of resistant bacterial infection."( In vitro interactions of ambroxol hydrochloride or amlodipine in combination with antibacterial agents against carbapenem-resistant Acinetobacter baumannii.
Li, X; Lu, C; Sun, S; Wang, D; Wang, Y, 2020
)
0.86
"The role of ambroxol hydrochloride combined with fiberoptic bronchoscopy in elderly patients with severe pneumonia remains unclear, we aimed to analyze this issue to provide evidences into the management of clinical pneumonia."( The application of ambroxol hydrochloride combined with fiberoptic bronchoscopy in elderly patients with severe pneumonia: A meta-analysis and systematic review.
Fan, W; Li, J; Tang, H; Wang, Q; Yuan, Z, 2022
)
1.43
"We searched PubMed et al databases up to October 20, 2021 for the randomized controlled trials on the application of ambroxol hydrochloride combined with fiberoptic bronchoscopy in elderly patients with severe pneumonia."( The application of ambroxol hydrochloride combined with fiberoptic bronchoscopy in elderly patients with severe pneumonia: A meta-analysis and systematic review.
Fan, W; Li, J; Tang, H; Wang, Q; Yuan, Z, 2022
)
1.26
"The high-dose ambroxol hydrochloride combined with fiberoptic bronchoscopy is beneficial to improve the patient's blood gas indicators, and reduce mortality in elderly patients with severe pneumonia."( The application of ambroxol hydrochloride combined with fiberoptic bronchoscopy in elderly patients with severe pneumonia: A meta-analysis and systematic review.
Fan, W; Li, J; Tang, H; Wang, Q; Yuan, Z, 2022
)
1.41
"To explore the curative effect of antibiotic combined with mucosolvan perfusion under fiber bronchoscope in treatment of pneumonia after severe cerebral hemorrhage."( Clinical effect of antibiotic combined with fiber bronchoscope perfusion in treatment of pneumonia after severe cerebral hemorrhage.
Li, J; Shi, J; Wang, W; Zhao, L, 2022
)
0.72

Bioavailability

A bioavailability of ambroxol of approximately 64% of that of a commercially available formulation could be achieved from gels containing an identical dose of the drug. The study was carried out under carefully controlled conditions on 12 healthy volunteers.

ExcerptReferenceRelevance
"The bioavailability of a new ambroxol sustained release preparation (75 mg) based on a dialyzing membrane for controlled release was studied in healthy volunteers after single and multiple oral dose in comparison with a standard sustained release formulation in a cross-over study under carefully controlled conditions."( Bioavailability of ambroxol sustained release preparations. Part II: Single and multiple oral dose studies in man.
Botterblom, MH; Guelen, PJ; Janssen, TJ; Valducci, R; Vree, TB, 1988
)
0.89
"In this population of healthy mate volunteers, results showed the bioavailability of loratadine and ambroxol from the new formulation and did not show impairment of absorption when the drugs were formulated in a combination tablet."( Pharmacokinetic properties of single-dose loratadine and ambroxol alone and combined in tablet formulations in healthy men.
Alcántar, F; Herrera, J; Morales, JM; Rodríguez, JM; Rosete, R; Villacampa, J, 2003
)
0.78
" The bioavailabilities of these drugs were not significantly different when released from gels formed at the two pH limits suggesting that normal variations of gastric acidity in the fasting state will have no effect on the bioavailability of these drugs when delivered using this vehicle."( The influence of variation of gastric pH on the gelation and release characteristics of in situ gelling pectin formulations.
Attwood, D; Dairaku, M; Fujiwara, M; Hirayama, T; Itoh, K; Kubo, W; Mikami, R; Miyazaki, S; Togashi, M, 2006
)
0.33
" Estimated high solubility and high permeability (P(app) = 45 x 10(-6) cm/s) of ambroxol rank it among well absorbed compounds and class I of BCS."( Transepithelial transport of ambroxol hydrochloride across human intestinal Caco-2 cell monolayers.
Kholová, D; Kvetina, J; Smetanová, L; Stetinová, V; Svoboda, Z, 2009
)
0.87
" The relative bioavailability of Amb OPT in rabbits relative to the commercial sustained capsule was 109."( Design and evaluation of osmotic pump-based controlled release system of Ambroxol Hydrochloride.
Cao, F; Cheng, X; Gao, Y; Sun, M; Zhai, G, 2011
)
0.6
"The ATP-binding cassette transporter P-glycoprotein (P-gp) is known to limit both brain penetration and oral bioavailability of many chemotherapy drugs."( A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
Ambudkar, SV; Brimacombe, KR; Chen, L; Gottesman, MM; Guha, R; Hall, MD; Klumpp-Thomas, C; Lee, OW; Lee, TD; Lusvarghi, S; Robey, RW; Shen, M; Tebase, BG, 2019
)
0.51
" However, given the extremely low solubility of BA, its bioavailability for oral absorptions is also low."( Baicalin/ambroxol hydrochloride combined dry powder inhalation formulation targeting lung delivery for treatment of idiopathic pulmonary fibrosis: Fabrication, characterization, pharmacokinetics, and pharmacodynamics.
Deng, X; Guo, P; He, J; Jia, B; Li, J; Liu, Z; Peng, H; Pi, J; Qi, D; Zhang, Y, 2023
)
1.33
" In the acetylcysteine + budesonide group, the absorption rate of lung imaging lesions and clinical efficacy were superior to those of the other two groups."( Acetylcysteine and budesonide for the treatment of refractory Mycoplasma pneumoniae pneumonia in children: a clinical observation.
Chen, C; Liu, K; Wang, Y; Zhang, C, 2023
)
0.91

Dosage Studied

The objective of this investigation was to develop a new, immediate-release, soft gel dosage form for ambroxol hydrochloride. Theophylline, Etofylline,. Guaiphenesine and Ambroxol Hydrochloride in a liquid dosage form.

ExcerptRelevanceReference
" The drug was given in the dosage forms of slow release capsules, syrup, drops, intramuscular injections and inhalations for about 14 days."( [Value of ambroxol in treatment of bronchial asthma and spastic bronchitis].
Obrzut, D; Rogalewska, A; Siergiejko, Z,
)
0.53
" The dosage regimen was as follows: adults--one 30-mg tablet of ambroxol 3 times/day; children--9 mg of ambroxol syrup, 4 times daily."( Multicenter study on the treatment of secretory otitis media with ambroxol. Importance of a surface-tension-lowering substance.
Passàli, D; Zavattini, G, 1987
)
0.75
" In addition, the animals receiving the high dosage of bromhexine had a significantly higher survival rate than other hybrids."( Effect of bromhexine, ambroxol, and placebo on clinical and histopathological changes in "Sjögren" mice.
Jensen, OA; Manthorpe, R; Prause, JU, 1985
)
0.58
" a commercial dose-equivalent, sustained-release dosage form."( [The pharmacokinetics and bioequivalence of various dosage forms of ambroxol].
Bishop-Freudling, GB; Matzkies, F; Miczka, M; Nitsche, V; Strobel, K; Vergin, H, 1985
)
0.5
" The drug was given orally in a dosage of 100 mg BID for ten days."( Therapeutic activity of ambroxol theophyllinacetate in chronic obstructive pulmonary diseases.
Primbs, K, 1985
)
0.58
" The present study was undertaken to confirm this finding, to determine its dose-response relationship and to identify the underlying mechanism of action."( Dose-dependent uricosuric effect of ambroxol.
Cornelissen, PJ; Jonkman, JH; Oosterhuis, B; Sollie, FA; Storm, G; Su, CA, 1993
)
0.56
"Mice with LPS-induced ALI that were treated with ambroxol at a dosage of 90 mg/kg per day significantly gained weight compared to the control and dexamethasone-treated groups."( Inhibition of inflammatory responses by ambroxol, a mucolytic agent, in a murine model of acute lung injury induced by lipopolysaccharide.
Bai, C; Song, Y; Su, X; Wang, L, 2004
)
0.85
" Determination of the compound in oral dosage forms was achieved using the standard addition method."( Adsorptive stripping voltammetric determination of ambroxol.
Habib, IH; Zayed, SI, 2005
)
0.58
" The present work reports simple, accurate and precise spectrophotometric methods for their simultaneous estimation from tablet dosage form."( Spectrophotometric estimation of ambroxol and cetirizine hydrochloride from tablet dosage form.
Chandorkar, JG; Gowekar, NM; Kasture, AV; Pande, VV; Tekade, AR, 2007
)
0.62
", Theophylline, Etofylline, Guaiphenesine and Ambroxol Hydrochloride in a liquid dosage form."( Simultaneous determination of multi drug components Theophylline, Etofylline, Guaiphenesine and Ambroxol Hydrochloride by validated RP-HPLC method in liquid dosage form.
Jain, JK; Khandhar, AP; Mishra, RK; Prakash, MS, 2008
)
0.82
"A reversed-phase high performance liquid chromatography (HPLC) method was developed, validated, and used for the quantitative determination of gatifloxacin (GA) and ambroxol hydrochloride (AM), from its tablet dosage form."( Simultaneous determination of gatifloxacin and ambroxol hydrochloride from tablet dosage form using reversed-phase high performance liquid chromatography.
Dehghan, MH; Feroz, S; Nanda, R; Nasreen, H; Shahed, M, 2008
)
0.8
" Stability study of pellets was performed as capsule dosage form in aluminium-PVDC packaging mode at room temperature, 40 degrees C, 40 degrees C/75%RH & 30 degrees C/70%RH for three months."( Stability study of ambroxol hydrochloride sustained release pellets coated with acrylic polymer.
Islam, KM; Jalil, RU; Kibria, G, 2009
)
0.68
" Patients in the treatment group took ambroxol orally at a dosage of 90 mg, three times per day for 3 months from the beginning of radiotherapy."( The protective effects of ambroxol on radiation lung injury and influence on production of transforming growth factor beta1 and tumor necrosis factor alpha.
Dai, M; Mao, WD; Shen, WS; Shu, ZQ; Xi, L; Xia, DH; Xv, C; Yang, HZ, 2010
)
0.93
" The proposed developed HPTLC method can be applied for identification and quantitative determination of ambroxol hydrochloride in bulk drug and dosage forms."( Stability-indicating HPTLC determination of ambroxol hydrochloride in bulk drug and pharmaceutical dosage form.
Jain, PS, 2010
)
0.84
" The proposed methods were applied for the determination of Ambroxol in tablet dosage forms."( Colorimetric and atomic absorption spectrometric determination of mucolytic drug ambroxol through ion-pair formation with iron and thiocyanate.
Levent, A; Sentürk, Z, 2010
)
0.83
"The objective of this investigation was to develop a new, immediate-release, soft gel dosage form for ambroxol hydrochloride, an oral expectorant and mucolytic agent."( Formulation development of ambroxol hydrochloride soft gel with application of statistical experimental design and response surface methodology.
Dabhi, M; Gohel, M; Nagori, S; Parikh, R; Sheth, N,
)
0.64
"The purpose of the present study was to investigate the possible anti-oxidant effect(s) of Ambroxol on neutrophils activated by ligand-binding of the drug with membrane-associated adhesion integrin CD11a and to estimate dose-response changes in oxygen free radical production."( Ambroxol inhibits neutrophil respiratory burst activated by alpha chain integrin adhesion.
Boner, AL; Gallo, G; Moser, S; Peroni, DG; Piacentini, GL; Pigozzi, R; Tenero, L; Zanoni, L,
)
1.79
" The developed methods have been successfully applied to the simultaneous determination of both drugs in commercial tablet dosage form."( Validated derivative and ratio derivative spectrophotometric methods for the simultaneous determination of levocetirizine dihydrochloride and ambroxol hydrochloride in pharmaceutical dosage form.
Ali, OI; Elgohary, RM; Ismail, NS, 2016
)
0.64
" The new formulation was bioequivalent to the co-administration of two drugs in separate dosage forms."( Investigation of a potential drug-drug interaction between salbutamol and ambroxol and bioequivalence of a new fixed-dose combination containing these two drugs in healthy Chinese subjects.
Ding, L; Li, T; Liu, L; Lu, J; Shi, X; Wang, Y; Yang, W; Zhao, S, 2018
)
0.71
" The proposed method is simple, accurate, reproducible and applied successfully to analyze three compounds in pure as well dosage form."( RP-HPLC-UV method development and validation for simultaneous determination of terbutaline sulphate, ambroxol HCl and guaifenesin in pure and dosage forms.
Itagimatha, N; Manjunatha, DH, 2019
)
0.73
" The significance of using drug combination is that it can reduce drug dosage requirements, reduce the toxic effects of agents and prevent or delay the emergence of drug resistance."( In vitro interactions of ambroxol hydrochloride or amlodipine in combination with antibacterial agents against carbapenem-resistant Acinetobacter baumannii.
Li, X; Lu, C; Sun, S; Wang, D; Wang, Y, 2020
)
0.86
" The advantages of the proposed method qualify it for routine analysis of the studied drugs either in single or co-formulated dosage form in quality control labs."( A quality-by-design eco-friendly UV-HPLC method for the determination of four drugs used to treat symptoms of common cold and COVID-19.
Abdallah, NA; El-Brashy, AM; Fathy, ME; Ibrahim, FA; Tolba, MM, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
aromatic amineAn amino compound in which the amino group is linked directly to an aromatic system.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (13)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Smad3Homo sapiens (human)Potency35.48130.00527.809829.0929AID588855
hypoxia-inducible factor 1, alpha subunit (basic helix-loop-helix transcription factor)Homo sapiens (human)Potency12.58930.00137.762544.6684AID914; AID915
cytochrome P450 2D6Homo sapiens (human)Potency1.19880.00108.379861.1304AID1645840
glucocerebrosidaseHomo sapiens (human)Potency35.48130.01268.156944.6684AID2101
cytochrome P450 2D6 isoform 1Homo sapiens (human)Potency3.16230.00207.533739.8107AID891
chromobox protein homolog 1Homo sapiens (human)Potency79.43280.006026.168889.1251AID540317
parathyroid hormone/parathyroid hormone-related peptide receptor precursorHomo sapiens (human)Potency44.66843.548119.542744.6684AID743266
lamin isoform A-delta10Homo sapiens (human)Potency31.62280.891312.067628.1838AID1487
Rap guanine nucleotide exchange factor 3Homo sapiens (human)Potency125.89206.309660.2008112.2020AID720707
TAR DNA-binding protein 43Homo sapiens (human)Potency1.41251.778316.208135.4813AID652104
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Lysosomal acid glucosylceramidaseHomo sapiens (human)IC50 (µMol)4.10000.03002.35898.8000AID699826
Cytochrome P450 2D6Homo sapiens (human)IC50 (µMol)0.55740.00002.015110.0000AID625249
Sodium-dependent serotonin transporterHomo sapiens (human)IC50 (µMol)3.39100.00010.86458.7096AID625222
Sodium-dependent serotonin transporterHomo sapiens (human)Ki1.80200.00000.70488.1930AID625222
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (135)

Processvia Protein(s)Taxonomy
angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
adaptive immune responseRap guanine nucleotide exchange factor 3Homo sapiens (human)
signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
adenylate cyclase-activating G protein-coupled receptor signaling pathwayRap guanine nucleotide exchange factor 3Homo sapiens (human)
associative learningRap guanine nucleotide exchange factor 3Homo sapiens (human)
Rap protein signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of actin cytoskeleton organizationRap guanine nucleotide exchange factor 3Homo sapiens (human)
negative regulation of syncytium formation by plasma membrane fusionRap guanine nucleotide exchange factor 3Homo sapiens (human)
intracellular signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of GTPase activityRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of angiogenesisRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of protein export from nucleusRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of stress fiber assemblyRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of phosphatidylinositol 3-kinase/protein kinase B signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
positive regulation of syncytium formation by plasma membrane fusionRap guanine nucleotide exchange factor 3Homo sapiens (human)
establishment of endothelial barrierRap guanine nucleotide exchange factor 3Homo sapiens (human)
cellular response to cAMPRap guanine nucleotide exchange factor 3Homo sapiens (human)
Ras protein signal transductionRap guanine nucleotide exchange factor 3Homo sapiens (human)
regulation of insulin secretionRap guanine nucleotide exchange factor 3Homo sapiens (human)
mitochondrion organizationLysosomal acid glucosylceramidaseHomo sapiens (human)
neuron projection developmentLysosomal acid glucosylceramidaseHomo sapiens (human)
glucosylceramide catabolic processLysosomal acid glucosylceramidaseHomo sapiens (human)
autophagyLysosomal acid glucosylceramidaseHomo sapiens (human)
lysosome organizationLysosomal acid glucosylceramidaseHomo sapiens (human)
cholesterol metabolic processLysosomal acid glucosylceramidaseHomo sapiens (human)
determination of adult lifespanLysosomal acid glucosylceramidaseHomo sapiens (human)
cellular response to starvationLysosomal acid glucosylceramidaseHomo sapiens (human)
response to pHLysosomal acid glucosylceramidaseHomo sapiens (human)
microglia differentiationLysosomal acid glucosylceramidaseHomo sapiens (human)
regulation of macroautophagyLysosomal acid glucosylceramidaseHomo sapiens (human)
antigen processing and presentationLysosomal acid glucosylceramidaseHomo sapiens (human)
lipid storageLysosomal acid glucosylceramidaseHomo sapiens (human)
cerebellar Purkinje cell layer formationLysosomal acid glucosylceramidaseHomo sapiens (human)
pyramidal neuron differentiationLysosomal acid glucosylceramidaseHomo sapiens (human)
respiratory electron transport chainLysosomal acid glucosylceramidaseHomo sapiens (human)
termination of signal transductionLysosomal acid glucosylceramidaseHomo sapiens (human)
lipid glycosylationLysosomal acid glucosylceramidaseHomo sapiens (human)
negative regulation of protein-containing complex assemblyLysosomal acid glucosylceramidaseHomo sapiens (human)
regulation of TOR signalingLysosomal acid glucosylceramidaseHomo sapiens (human)
positive regulation of proteasomal ubiquitin-dependent protein catabolic processLysosomal acid glucosylceramidaseHomo sapiens (human)
negative regulation of interleukin-6 productionLysosomal acid glucosylceramidaseHomo sapiens (human)
T cell differentiation in thymusLysosomal acid glucosylceramidaseHomo sapiens (human)
response to testosteroneLysosomal acid glucosylceramidaseHomo sapiens (human)
positive regulation of protein dephosphorylationLysosomal acid glucosylceramidaseHomo sapiens (human)
proteasome-mediated ubiquitin-dependent protein catabolic processLysosomal acid glucosylceramidaseHomo sapiens (human)
positive regulation of protein-containing complex disassemblyLysosomal acid glucosylceramidaseHomo sapiens (human)
negative regulation of MAP kinase activityLysosomal acid glucosylceramidaseHomo sapiens (human)
negative regulation of neuron apoptotic processLysosomal acid glucosylceramidaseHomo sapiens (human)
response to estrogenLysosomal acid glucosylceramidaseHomo sapiens (human)
sphingosine biosynthetic processLysosomal acid glucosylceramidaseHomo sapiens (human)
ceramide biosynthetic processLysosomal acid glucosylceramidaseHomo sapiens (human)
cell maturationLysosomal acid glucosylceramidaseHomo sapiens (human)
brain morphogenesisLysosomal acid glucosylceramidaseHomo sapiens (human)
homeostasis of number of cellsLysosomal acid glucosylceramidaseHomo sapiens (human)
negative regulation of inflammatory responseLysosomal acid glucosylceramidaseHomo sapiens (human)
neuromuscular processLysosomal acid glucosylceramidaseHomo sapiens (human)
neuron apoptotic processLysosomal acid glucosylceramidaseHomo sapiens (human)
establishment of skin barrierLysosomal acid glucosylceramidaseHomo sapiens (human)
microglial cell proliferationLysosomal acid glucosylceramidaseHomo sapiens (human)
motor behaviorLysosomal acid glucosylceramidaseHomo sapiens (human)
cellular response to tumor necrosis factorLysosomal acid glucosylceramidaseHomo sapiens (human)
hematopoietic stem cell proliferationLysosomal acid glucosylceramidaseHomo sapiens (human)
response to dexamethasoneLysosomal acid glucosylceramidaseHomo sapiens (human)
lymphocyte migrationLysosomal acid glucosylceramidaseHomo sapiens (human)
response to thyroid hormoneLysosomal acid glucosylceramidaseHomo sapiens (human)
beta-glucoside catabolic processLysosomal acid glucosylceramidaseHomo sapiens (human)
positive regulation of protein lipidationLysosomal acid glucosylceramidaseHomo sapiens (human)
positive regulation of neuronal action potentialLysosomal acid glucosylceramidaseHomo sapiens (human)
positive regulation of autophagy of mitochondrion in response to mitochondrial depolarizationLysosomal acid glucosylceramidaseHomo sapiens (human)
autophagosome organizationLysosomal acid glucosylceramidaseHomo sapiens (human)
regulation of lysosomal protein catabolic processLysosomal acid glucosylceramidaseHomo sapiens (human)
xenobiotic metabolic processCytochrome P450 2D6Homo sapiens (human)
steroid metabolic processCytochrome P450 2D6Homo sapiens (human)
cholesterol metabolic processCytochrome P450 2D6Homo sapiens (human)
estrogen metabolic processCytochrome P450 2D6Homo sapiens (human)
coumarin metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
alkaloid catabolic processCytochrome P450 2D6Homo sapiens (human)
monoterpenoid metabolic processCytochrome P450 2D6Homo sapiens (human)
isoquinoline alkaloid metabolic processCytochrome P450 2D6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2D6Homo sapiens (human)
retinol metabolic processCytochrome P450 2D6Homo sapiens (human)
long-chain fatty acid biosynthetic processCytochrome P450 2D6Homo sapiens (human)
negative regulation of bindingCytochrome P450 2D6Homo sapiens (human)
oxidative demethylationCytochrome P450 2D6Homo sapiens (human)
negative regulation of cellular organofluorine metabolic processCytochrome P450 2D6Homo sapiens (human)
arachidonic acid metabolic processCytochrome P450 2D6Homo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of protein phosphorylationTAR DNA-binding protein 43Homo sapiens (human)
mRNA processingTAR DNA-binding protein 43Homo sapiens (human)
RNA splicingTAR DNA-binding protein 43Homo sapiens (human)
negative regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
regulation of protein stabilityTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of insulin secretionTAR DNA-binding protein 43Homo sapiens (human)
response to endoplasmic reticulum stressTAR DNA-binding protein 43Homo sapiens (human)
positive regulation of protein import into nucleusTAR DNA-binding protein 43Homo sapiens (human)
regulation of circadian rhythmTAR DNA-binding protein 43Homo sapiens (human)
regulation of apoptotic processTAR DNA-binding protein 43Homo sapiens (human)
negative regulation by host of viral transcriptionTAR DNA-binding protein 43Homo sapiens (human)
rhythmic processTAR DNA-binding protein 43Homo sapiens (human)
regulation of cell cycleTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA destabilizationTAR DNA-binding protein 43Homo sapiens (human)
3'-UTR-mediated mRNA stabilizationTAR DNA-binding protein 43Homo sapiens (human)
nuclear inner membrane organizationTAR DNA-binding protein 43Homo sapiens (human)
amyloid fibril formationTAR DNA-binding protein 43Homo sapiens (human)
regulation of gene expressionTAR DNA-binding protein 43Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (39)

Processvia Protein(s)Taxonomy
guanyl-nucleotide exchange factor activityRap guanine nucleotide exchange factor 3Homo sapiens (human)
protein bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
protein domain specific bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
cAMP bindingRap guanine nucleotide exchange factor 3Homo sapiens (human)
galactosylceramidase activityLysosomal acid glucosylceramidaseHomo sapiens (human)
glucosylceramidase activityLysosomal acid glucosylceramidaseHomo sapiens (human)
signaling receptor bindingLysosomal acid glucosylceramidaseHomo sapiens (human)
scavenger receptor bindingLysosomal acid glucosylceramidaseHomo sapiens (human)
protein bindingLysosomal acid glucosylceramidaseHomo sapiens (human)
glucosyltransferase activityLysosomal acid glucosylceramidaseHomo sapiens (human)
steryl-beta-glucosidase activityLysosomal acid glucosylceramidaseHomo sapiens (human)
monooxygenase activityCytochrome P450 2D6Homo sapiens (human)
iron ion bindingCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activityCytochrome P450 2D6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2D6Homo sapiens (human)
heme bindingCytochrome P450 2D6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2D6Homo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
RNA polymerase II cis-regulatory region sequence-specific DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
double-stranded DNA bindingTAR DNA-binding protein 43Homo sapiens (human)
RNA bindingTAR DNA-binding protein 43Homo sapiens (human)
mRNA 3'-UTR bindingTAR DNA-binding protein 43Homo sapiens (human)
protein bindingTAR DNA-binding protein 43Homo sapiens (human)
lipid bindingTAR DNA-binding protein 43Homo sapiens (human)
identical protein bindingTAR DNA-binding protein 43Homo sapiens (human)
pre-mRNA intronic bindingTAR DNA-binding protein 43Homo sapiens (human)
molecular condensate scaffold activityTAR DNA-binding protein 43Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (34)

Processvia Protein(s)Taxonomy
plasma membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
cortical actin cytoskeletonRap guanine nucleotide exchange factor 3Homo sapiens (human)
plasma membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
microvillusRap guanine nucleotide exchange factor 3Homo sapiens (human)
endomembrane systemRap guanine nucleotide exchange factor 3Homo sapiens (human)
membraneRap guanine nucleotide exchange factor 3Homo sapiens (human)
lamellipodiumRap guanine nucleotide exchange factor 3Homo sapiens (human)
filopodiumRap guanine nucleotide exchange factor 3Homo sapiens (human)
extracellular exosomeRap guanine nucleotide exchange factor 3Homo sapiens (human)
lysosomeLysosomal acid glucosylceramidaseHomo sapiens (human)
lysosomal membraneLysosomal acid glucosylceramidaseHomo sapiens (human)
endoplasmic reticulumLysosomal acid glucosylceramidaseHomo sapiens (human)
Golgi apparatusLysosomal acid glucosylceramidaseHomo sapiens (human)
trans-Golgi networkLysosomal acid glucosylceramidaseHomo sapiens (human)
lysosomal lumenLysosomal acid glucosylceramidaseHomo sapiens (human)
extracellular exosomeLysosomal acid glucosylceramidaseHomo sapiens (human)
mitochondrionCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulumCytochrome P450 2D6Homo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2D6Homo sapiens (human)
cytoplasmCytochrome P450 2D6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2D6Homo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
intracellular non-membrane-bounded organelleTAR DNA-binding protein 43Homo sapiens (human)
nucleusTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
perichromatin fibrilsTAR DNA-binding protein 43Homo sapiens (human)
mitochondrionTAR DNA-binding protein 43Homo sapiens (human)
cytoplasmic stress granuleTAR DNA-binding protein 43Homo sapiens (human)
nuclear speckTAR DNA-binding protein 43Homo sapiens (human)
interchromatin granuleTAR DNA-binding protein 43Homo sapiens (human)
nucleoplasmTAR DNA-binding protein 43Homo sapiens (human)
chromatinTAR DNA-binding protein 43Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (40)

Assay IDTitleYearJournalArticle
AID1296008Cytotoxic Profiling of Annotated Libraries Using Quantitative High-Throughput Screening2020SLAS discovery : advancing life sciences R & D, 01, Volume: 25, Issue:1
Cytotoxic Profiling of Annotated and Diverse Chemical Libraries Using Quantitative High-Throughput Screening.
AID1347160Primary screen NINDS Rhodamine qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346987P-glycoprotein substrates identified in KB-8-5-11 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID1347159Primary screen GU Rhodamine qHTS for Zika virus inhibitors: Unlinked NS2B-NS3 protease assay2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1346986P-glycoprotein substrates identified in KB-3-1 adenocarcinoma cell line, qHTS therapeutic library screen2019Molecular pharmacology, 11, Volume: 96, Issue:5
A High-Throughput Screen of a Library of Therapeutics Identifies Cytotoxic Substrates of P-glycoprotein.
AID504749qHTS profiling for inhibitors of Plasmodium falciparum proliferation2011Science (New York, N.Y.), Aug-05, Volume: 333, Issue:6043
Chemical genomic profiling for antimalarial therapies, response signatures, and molecular targets.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID699828Inhibition of alpha galactosidase in human fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID588208Literature-mined public compounds from Lowe et al phospholipidosis modelling dataset2010Molecular pharmaceutics, Oct-04, Volume: 7, Issue:5
Predicting phospholipidosis using machine learning.
AID699838Cytotoxicity against human fibroblasts expressing beta-cerebroglucosidase L444P/L444P mutant after 5 days by LDH assay2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699836Cytotoxicity against human fibroblasts expressing beta-cerebroglucosidase N370S/N370S mutant at 10 and 30 uM after 5 days by LDH assay2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699830Inhibition of beta hexoseaminidase in human fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699834Activation of beta-glucocerebrosidase L444P/L444P mutant in Gaucher patient fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate after 5 days by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID129460Bronchosecretory activity measured as tracheal secretion of phenol red in mouse after oral administration1987Journal of medicinal chemistry, Mar, Volume: 30, Issue:3
2-[(3-Pyridinylmethyl)thio]pyrimidine derivatives: new bronchosecretolytic agents.
AID731596Induction of beta glucosidase N370S mutant activity in fibroblasts derived from Gaucher disease type 1 patient at 60 uM relative to control2013Journal of medicinal chemistry, Apr-11, Volume: 56, Issue:7
Pharmacological chaperones as therapeutics for lysosomal storage diseases.
AID699826Inhibition of beta-glucocerebrosidase in human fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699837Cytotoxicity against human fibroblasts expressing beta-cerebroglucosidase N370S/N370S mutant at 10 to 90 uM after 5 days by LDH assay2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID699832Activation of beta-glucocerebrosidase N370S/N370S mutant in Gaucher patient fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate at 10 and 30 uM after 5 days by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699827Inhibition of alpha glucosidase in human fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699829Inhibition of beta galactosidase in human fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID699835Cytotoxicity against human fibroblasts at 10 and 30 uM after 5 days by LDH assay2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID699841Activation of beta-glucocerebrosidase in human fibroblast lysate using 4-methylumbelliferyl beta-D-glycopyranoside as substrate at 10 and 30 uM after 5 days by fluorimetric analysis2012Journal of medicinal chemistry, Aug-09, Volume: 55, Issue:15
Conformationally-locked N-glycosides with selective β-glucosidase inhibitory activity: identification of a new non-iminosugar-type pharmacological chaperone for Gaucher disease.
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID504810Antagonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588499High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain A protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588497High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Botulinum neurotoxin light chain F protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Current protocols in cytometry, Oct, Volume: Chapter 13Microsphere-based flow cytometry protease assays for use in protease activity detection and high-throughput screening.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2006Cytometry. Part A : the journal of the International Society for Analytical Cytology, May, Volume: 69, Issue:5
Microsphere-based protease assays and screening application for lethal factor and factor Xa.
AID588501High-throughput multiplex microsphere screening for inhibitors of toxin protease, specifically Lethal Factor Protease, MLPCN compound set2010Assay and drug development technologies, Feb, Volume: 8, Issue:1
High-throughput multiplex flow cytometry screening for botulinum neurotoxin type a light chain protease inhibitors.
AID504812Inverse Agonists of the Thyroid Stimulating Hormone Receptor: HTS campaign2010Endocrinology, Jul, Volume: 151, Issue:7
A small molecule inverse agonist for the human thyroid-stimulating hormone receptor.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1440979Chaperone activity assessed as enhancement of GCase L444P/P415R mutant enzyme in skin fibroblasts derived from GD patient at 50 uM using 4-MUG as substrate after 20 hrs by luminescence spectrophotometry relative to control2017Journal of medicinal chemistry, 03-09, Volume: 60, Issue:5
Fluorinated Chaperone-β-Cyclodextrin Formulations for β-Glucocerebrosidase Activity Enhancement in Neuronopathic Gaucher Disease.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (672)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990202 (30.06)18.7374
1990's88 (13.10)18.2507
2000's136 (20.24)29.6817
2010's176 (26.19)24.3611
2020's70 (10.42)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 121.26

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index121.26 (24.57)
Research Supply Index6.74 (2.92)
Research Growth Index4.63 (4.65)
Search Engine Demand Index227.63 (26.88)
Search Engine Supply Index2.02 (0.95)

This Compound (121.26)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials130 (18.21%)5.53%
Reviews59 (8.26%)6.00%
Case Studies36 (5.04%)4.05%
Observational5 (0.70%)0.25%
Other484 (67.79%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (29)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Ambroxol as a Novel Disease Modifying Treatment for Parkinson's Disease Dementia [NCT02914366]Phase 255 participants (Actual)Interventional2015-11-30Active, not recruiting
Ambroxol to Slow Progression in Parkinson Disease: A Phase IIIa Multi-centre Randomised Placebo-controlled Trial [NCT05778617]Phase 3330 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Investigation of the Metabolism and Pharmacokinetics of an Open Label Single Dose of 20 mg Ambroxol Administered as a Lozenge Together With an Oral Solution of 0.4 mg [14C]-Ambroxol in Healthy Male Volunteers [NCT02194257]Phase 112 participants (Actual)Interventional2008-10-31Completed
A Single-Centre, Open-label, Exploratory Study of the Effect of 20 mg Ambroxol Hydrochloride on Cough Reflex Sensitivity in Patients With Acute Cough. [NCT03415269]Phase 214 participants (Actual)Interventional2018-02-15Completed
A Retrospective, Real-world Study of Eucalyptol, Limonene and Pinene Enteric Soft Capsules Used in the Expectorant Treatment of Community-acquired Pneumonia [NCT05002192]10,000 participants (Anticipated)Observational2020-09-01Recruiting
An Open Label, Randomised, Two-way Crossover Study in Healthy Female and Male Volunteers to Evaluate the Relative Bioavailability of a 20 mg Ambroxol Hydrochloride Lozenge in Comparison to 30 mg Ambroxol Hydrochloride Syrup (Mucosolvan®) [NCT02194296]Phase 120 participants (Actual)Interventional1999-06-30Completed
A Multi-centre, Randomised, Double-blind, Placebo Controlled Parallel Group, Dose Finding Study to Assess the Efficacy and Safety of Ambroxol Spray (2.5mg, 5mg or 10mg) Versus Placebo for the Temporary Relief of Sore Throat Pain in Patients With Acute Pha [NCT01361802]Phase 2494 participants (Actual)Interventional2011-05-31Completed
Relative Bioavailability of Ambroxol Hydrochloride Following Oral Administration of Soft Pastilles 15 mg (Test) Compared to 15 mg of Syrup (15mg/5mL, Reference I) and Compared to 15 mg of Syrup (30mg/5mL) (Reference II) in Healthy Male and Female Voluntee [NCT02194270]Phase 124 participants (Actual)Interventional2004-09-30Completed
[NCT02792946]Phase 3244 participants (Actual)Interventional2015-11-30Completed
A Double-blind (at Each Dose Level), Randomised, Placebo Controlled Phase I Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges (Dosage: 20, 40, 80 mg Three Times Daily) Over 4 Days in Healthy [NCT02194283]Phase 134 participants (Actual)Interventional2009-10-31Completed
AMBroxol Therapy for ALS (AMBALS) Trial: a Double-blind, Randomised, Placebo-controlled Phase 2 Clinical Trial of Ambroxol for ALS [NCT05959850]Phase 250 participants (Anticipated)Interventional2023-06-13Recruiting
Ambroxol Therapy for Patients With Type 1 Gaucher Disease and Suboptimal Response to Enzyme Replacement Therapy [NCT03950050]Phase 240 participants (Actual)Interventional2019-03-01Completed
A Randomised, Double-blind, Placebo Controlled, Parallel Group, Multicentre Trial to Assess the Efficacy and Safety of Ambroxol Lozenges 20 mg (Hard Boiled Lozenges) Versus Placebo for the Relief of Sore Throat Pain in Patients With Acute Pharyngitis [NCT03583658]Phase 3390 participants (Actual)Interventional2018-06-30Completed
Double-blind, Randomized, Placebo-controlled Trial to Investigate the Efficacy and Tolerance of Ambroxol Lozenges 20 mg in the Treatment of Sore Throat in Patients With Acute Viral Pharyngitis [NCT00525044]Phase 3249 participants (Actual)Interventional2007-08-01Completed
A Clinical Trial to Demonstrate Clinical Efficacy on Cognitive, Neuropsychiatric and Functional Outcomes of Ambroxol in New and Early Patients With Prodromal and Mild Dementia With Lewybodies [NCT04588285]Phase 2180 participants (Anticipated)Interventional2021-05-04Recruiting
A Phase IIA Prospective, Single-Centre, Open Label Clinical Trial to Evaluate the Safety, Tolerability and Pharmacodynamic Effects of Ambroxol in Patients With Parkinson Disease: Ambroxol in Disease Modification in Parkinson Disease [NCT02941822]Phase 223 participants (Actual)Interventional2016-12-31Completed
Efficacy and Tolerability of Ambroxol Lozenge 20 mg in Relieving Pain of Sore Throat in Patients With Acute Viral Pharyngitis-A Randomised, Double-blind,Placebo- and Active-controlled Parallel Group Study [NCT00148499]Phase 3751 participants Interventional2005-10-31Completed
Ambroxol as a Novel Disease Modifying Treatment for Lewy Body Dementia [NCT04405596]Phase 1/Phase 215 participants (Anticipated)Interventional2025-01-31Not yet recruiting
Ambroxol as a Disease-modifying Treatment to Reduce the Risk of Cognitive Impairment in GBA-associated Parkinson's Disease. A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Trial [NCT05287503]Phase 265 participants (Actual)Interventional2022-02-15Active, not recruiting
A Randomised Controlled Trial to Assess the Efficacy of Intravenous Ambroxol Hydrochloride as an Adjunct Therapy for Severe Pneumonia in Critically Ill Patients [NCT05663905]Phase 432 participants (Actual)Interventional2023-01-07Completed
GRoningen Early-PD Ambroxol Treatment (GREAT) Trial: A Randomised, Double-blind, Placebo-controlled, Singlecenter Trial With Ambroxol in Parkinson Patients With a GBA Mutation [NCT05830396]Phase 2/Phase 380 participants (Anticipated)Interventional2023-05-31Recruiting
An Open-Label, Dose Escalation With 2 Dose Levels, Proof-of-Concept Clinical Trial of Ambroxol for the Treatment of Type I Gaucher Disease [NCT01463215]Phase 1/Phase 220 participants (Anticipated)Interventional2012-12-31Suspended
Efficacy and Tolerability of Ambroxol Lozenges 20mg in Relieving the Pain of Sore Throat in Adolescent Patients With Acute Viral Pharyngitis - A Randomised, Double-blind, Placebo-controlled Parallel Group Study. AMBROSIA: Ambroxol Lozenges In Sore Throat [NCT00144274]Phase 3220 participants Interventional2005-04-30Completed
Relative Bioavailability Study Between Two Formulations Containing Ambroxol Hydrochloride [NCT02572609]Phase 10 participants Interventional2011-11-30Completed
[NCT01713179]Phase 1/Phase 220 participants (Actual)Interventional2011-08-31Completed
Effect of Ambroxol on the Inflammatory Markers and Clinical Outcome of Patients With Diabetic Peripheral Neuropathy [NCT05558878]80 participants (Anticipated)Interventional2022-10-01Not yet recruiting
Open Label, Randomized, 3-sequence Crossover Study to Evaluate the Drug-drug Interaction Between Ambroxol HCl and Levodropropizine in Healthy Male Volunteers [NCT01573663]Phase 121 participants (Actual)Interventional2012-02-29Completed
A Phase III, Multi-centre, Randomized, Rater- and Patient-blind, Placebo- and Active-controlled, Parallel Group Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily (Active Test Tre [NCT03843541]Phase 3333 participants (Actual)Interventional2019-06-25Completed
An Open-label, Randomised, Multiple-dose, Three-period Crossover Study in Healthy Male and Female Volunteers to Characterise Pharmacokinetics and Assess the Relative Bioavailability of Two New Oral Formulations of Ambroxol Hydrochloride as Lasolvan® Prolo [NCT02036775]Phase 124 participants (Actual)Interventional2014-03-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00525044 (5) [back to overview]Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline
NCT00525044 (5) [back to overview]Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation
NCT00525044 (5) [back to overview]Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation
NCT00525044 (5) [back to overview]Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge
NCT00525044 (5) [back to overview]Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge
NCT02036775 (11) [back to overview]Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State
NCT02036775 (11) [back to overview]Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg
NCT02036775 (11) [back to overview]Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State
NCT02036775 (11) [back to overview]Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State
NCT02036775 (11) [back to overview]Maximum Measured Concentration of the Analyte in Plasma at Steady State
NCT02036775 (11) [back to overview]Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma
NCT02036775 (11) [back to overview]Peak-trough Swing
NCT02036775 (11) [back to overview]Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss
NCT02036775 (11) [back to overview]Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)
NCT02036775 (11) [back to overview]Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval
NCT02036775 (11) [back to overview]Time Period When Concentration of the Analyte Exceeds Cav ss
NCT02572609 (2) [back to overview]AUC0-t
NCT02572609 (2) [back to overview]Cmax
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride
NCT03843541 (15) [back to overview]Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride
NCT03843541 (15) [back to overview]Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo
NCT03843541 (15) [back to overview]Number of Participants With Adverse Events
NCT03843541 (15) [back to overview]Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo

Sum of Pain Intensity Difference (SPIDnorm)-Time-weighted Average of the Pain Intensity Difference (PID) From Pre-dose Baseline Over the First 3 Hours After the First Lozenge Expressed as a Ratio of the Pre-dose Baseline

The calculation will be based on the pain intensity (PI) assessment by the patient before and then at (pain intensity difference at 30 minutes (PID30)), (pain intensity difference at 60 minutes (PID60)), (pain intensity difference at 120 minutes (PID120)) and (pain intensity difference at 180 minutes (PID180)) after the 1st lozenge. Using the difference in PI from pre-dose baseline for each time point subsequent to dosing, the SPIDnorm will be calculated as SPIDnorm = (30*PID30 + 30*PID60 + 60*PID120 + 60*PID180)/(180*PI (baseline)) The patient rates the intensity of his sore throat pain on a 6-point Verbal Rating Scale (VRS) pain intensity (PI) before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain. (NCT00525044)
Timeframe: pre-dose baseline and 30, 60, 120, and 180 minutes

Interventionratio (Least Squares Mean)
Ambroxol Lozenges 20 mg-0.40
Placebo-0.34

[back to top]

Assessment of Patients' Assessment of Effectiveness on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation

"Assessment of Patients' Assessment of Effectiveness on a 5-point VRS (very good, good, neither good nor poor, not very good, not at all good) at pre-dose baseline and at the end-of-study evaluation" (NCT00525044)
Timeframe: Day 1 and Day 2

,
Interventionpercentage of participants (Number)
Day 1_Very goodDay 1_GoodDay 1_Neither good nor poorDay 1_Not very goodDay 1_Not at all goodDay 2_Very goodDay 2_GoodDay 2_Neither good nor poorDay 2_Not very goodDay 2_Not at all good
Ambroxol Lozenges 20 mg13.758.119.46.52.424.356.814.43.60.9
Placebo8.052.018.416.05.614.252.216.813.33.5

[back to top]

Assessment of Redness of the Pharyngeal Mucosa by the Investigator on a 5-point VRS at Pre-dose Baseline and at the End-of-study Evaluation

Assessment of redness of the pharyngeal mucosa by the investigator on a 5-point VRS (normal, slightly red, clearly red, very red, severe inflammation) at pre-dose baseline and at the end-of-study evaluation. (NCT00525044)
Timeframe: Day 1 and Day 2

,
Interventionpercentage of participants (Number)
Day 1_NormalDay 1_Slightly redDay 1_ Clearly redDay 1_Very redDay 1_Severe inflammationDay 2_NormalDay 2_Slightly redDay 2_Clearly redDay 2_Very redDay 2_Severe inflammation
Ambroxol Lozenges 20 mg0.012.153.229.84.812.166.918.52.40.0
Placebo0.812.850.432.04.010.566.921.80.80.0

[back to top]

Pain Intensity (PI) as Rated on a 6-point VRS by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge

"Pain intensity (PI) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge.~The patient rates the intensity of his sore throat condition on a 6-point rating scale [VRS(PI)-verbal rating scale (pain intensity)] before taking the first lozenge and 30, 60, 120 and 180 minutes thereafter, and enters his rating in his patient's diary . The rating scale is as follows: 0=no pain; 1=hardly any pain; 2=slight pain; 3=moderate pain; 4=severe pain; 5=very severe pain.~Adjusted Mean (Standard Error) are presented for this outcome measure." (NCT00525044)
Timeframe: 0.5, 1, 2 and 3 hours

,
Interventionscore on a scale (Least Squares Mean)
30 minutes60 minutes120 minutes180 minutes
Ambroxol Lozenges 20 mg2.92.62.32.2
Placebo3.12.82.72.5

[back to top]

Pain Intensity Difference From Pre-dose Baseline (PID) as Rated on a 6-point Verbal Rating Scale (VRS) by the Patient at 0.5, 1, 2 and 3 Hours After the First Lozenge

"Pain intensity difference from pre-dose baseline (PID) as rated on a 6-point Verbal Rating Scale (VRS) by the patient at 0.5, 1, 2 and 3 hours after the first lozenge.~Adjusted Mean (Standard Error) are presented for this outcome measure." (NCT00525044)
Timeframe: pre-dose baseline and 0.5, 1, 2 and 3 hours

,
Interventionscore on a scale (Least Squares Mean)
30 minutes60 minutes120 minutes180 minutes
Ambroxol Lozenges 20 mg-1.1-1.4-1.8-1.9
Placebo-1.0-1.2-1.4-1.6

[back to top]

Time From Dosing to the Maximum Concentration of the Analyte in Plasma at Steady State

Time from dosing to the maximum concentration of the analyte in plasma at steady state (tmax ss). For Lasolvan 30mg and Lasolvan 60mg, tmax ss was determined as tmax ss 0-12 and tmax ss 12-24. (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

,,
Interventionhours (Median)
Tmax,ss,0-12h (N=0, 23, 23)Tmax,ss,12-24h (N=0, 23, 23)Tmax,ss,h (N=23, 0, 0)
Lasolvan 30mg2.0014.00NA
Lasolvan 60mg1.0013.50NA
Lasolvan 75mgNANA6.00

[back to top]

Area Under the Concentration-time Curve of the Analyte in Plasma at Steady State During 0-24 h, Adjusted to a Daily Dose of 60 mg

Area under the concentration-time curve of the analyte in plasma at steady state during 0-24 h, adjusted to a daily dose of 60 mg (AUCss 0-24 norm) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionng*h/mL (Geometric Mean)
Lasolvan 75mg945.667
Lasolvan 60mg1110.095
Lasolvan 30mg1070.909

[back to top]

Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 to 24 h at Steady State

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 24 h at steady state (AUCss 0-24) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionng*h/mL (Geometric Mean)
Lasolvan 75mg1182.084
Lasolvan 60mg1110.095
Lasolvan 30mg1070.909

[back to top]

Average Concentration of the Analyte in Plasma in the Time Interval of 0 to 24 h at Steady State

Average concentration of the analyte in plasma in the time interval of 0 to 24 h at steady state (Cav ss) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionng/mL (Geometric Mean)
Lasolvan 75mg49.254
Lasolvan 60mg46.254
Lasolvan 30mg44.621

[back to top]

Maximum Measured Concentration of the Analyte in Plasma at Steady State

Maximum measured concentration of the analyte in plasma at steady state (Cmax ss) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionng/mL (Geometric Mean)
Lasolvan 75mg73.510
Lasolvan 60mg90.755
Lasolvan 30mg87.289

[back to top]

Peak-trough Fluctuation Between Minimum and Maximum Concentration of the Analyte in Plasma

Peak-trough fluctuation between minimum and maximum concentration of the analyte in plasma (PTF) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionng/mL (Mean)
Lasolvan 75mg0.994
Lasolvan 60mg1.482
Lasolvan 30mg1.483

[back to top]

Peak-trough Swing

Peak-trough swing (PTS) calculated as ((Cmax,ss - Cmin,ss / Cav,ss)*100) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionpercentage of ng/mL (Mean)
Lasolvan 75mg205.054
Lasolvan 60mg313.106
Lasolvan 30mg322.120

[back to top]

Plateau Time During Which Concentration of the Analyte in Plasma Exceeds 75% of Cmax ss

Plateau time during which concentration of the analyte in plasma exceeds 75% of Cmax ss (T(C>75% Cmax ss)) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionhours (Median)
Lasolvan 75mg9.00
Lasolvan 60mg2.25
Lasolvan 30mg2.00

[back to top]

Rate of Absorption at Steady State (Cmax ss/AUCss 0-24)

Metric which characterises the rate of absorption at steady state (Cmax ss/AUCss 0-24) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Intervention1/h (Geometric Mean)
Lasolvan 75mg0.062
Lasolvan 60mg0.082
Lasolvan 30mg0.082

[back to top]

Steady State Concentration of the Analyte in Plasma at the End of Dosing Interval

Steady state concentration of the analyte in plasma at the end of dosing interval (Cmin ss) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionng/mL (Geometric Mean)
Lasolvan 75mg24.891
Lasolvan 60mg22.740
Lasolvan 30mg21.523

[back to top]

Time Period When Concentration of the Analyte Exceeds Cav ss

Time period when the concentration of the analyte exceeds Cav ss (T (C>Cav ss)) (NCT02036775)
Timeframe: Pre-dose, 30min, 1h, 1h 30min, 2h, 3h, 4h, 5h, 6h, 7h 30min, 9h, 10h 30min, 12h, 14h, 17h, 20h, 24h after the morning dose for all treatments; also 15min, 45min, 12h 15min, 12h 30min, 12h 45min, 13h, 13h 30min, 15h, 16h for Lasolvan 60mg and Lasolvan 30mg

Interventionhours (Median)
Lasolvan 75mg10.500
Lasolvan 60mg8.500
Lasolvan 30mg7.750

[back to top]

AUC0-t

Area under the plasma concentration-time curve, calculated by the trapezoidal methods from time 0 to time t, where t is the time for the last concentration experimentally determined above the Limit of Quantification (LOQ). (NCT02572609)
Timeframe: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h

Interventionng.h/mL (Geometric Mean)
Mucosolvan ® Adult Syrup256.66
Ambroxol Hydrochloride Soft Pastille307.00

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Cmax

Maximum plasma concentration achieved (NCT02572609)
Timeframe: 0:00h (hours), 0:15h, 0:30h, 0:45h, 1:00h, 1:15h, 1:30h, 1:45h, 2:00h, 2:20h, 2:40, 3:00, 3:30h, 4:00h, 5:00h, 6:00h, 8:00h, 12:00h, 16:00h, 24:00h, 36:00h and 48:00h

Interventionng/mL (Geometric Mean)
Mucosolvan ® Adult Syrup31.27
Ambroxol Hydrochloride Soft Pastille35.50

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Change From Baseline to Day 3 in Mean Expectoration Difficulty Score of NAC and Placebo

The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst. (NCT03843541)
Timeframe: From Baseline to Day 3

InterventionScore (Mean)
N-Acetylcysteine-0.8
Placebo-0.7

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Change From Baseline to Day 3 in Mean Sputum Viscosity Score of NAC and Placebo

The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline to Day 3

InterventionScore (Mean)
N-Acetylcysteine-0.6
Placebo-0.6

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Change From Baseline to Day 7 in Mean Expectoration Difficulty Score of NAC and Ambroxol Hydrochloride

The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3= worst (NCT03843541)
Timeframe: From Baseline upto Day 7

InterventionScore (Mean)
N-Acetylcysteine-1.4
Ambroxol Hydrochloride-1.3

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Change From Baseline to Day 7 in Mean Sputum Viscosity Score of NAC and Ambroxol Hydrochloride

The non-inferiority of NAC versus ambroxol in terms of change from baseline to Day 7 of mean sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From baseline upto Day 7

InterventionScore (Mean)
N-Acetylcysteine-1.2
Ambroxol Hydrochloride-1.2

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Change From Baseline to Day 7 of Mean Sputum Viscosity Score of NAC and Placebo

The superiority of slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From baseline upto Day 7

InterventionScore (Mean)
N-Acetylcysteine-1.2
Placebo-1.0

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Change From Baseline to Day 7 Treatment of Mean Expectoration Difficulty Score of NAC and Placebo

The superiority of slow intravenous infusion of NAC 600 mg twice daily to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst. (NCT03843541)
Timeframe: From Baseline upto Day 7

InterventionScore (Mean)
N-Acetylcysteine-1.4
Placebo-1.1

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Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of Ambroxol Hydrochloride and Placebo

The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionScore (Mean)
Change from baseline to Day 3Change from baseline to Day 7
Ambroxol Hydrochloride-0.4-0.7
Placebo-0.5-0.6

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Change From Baseline to Day 3 and to Day 7 in Mean Cough Severity Score of NAC and Placebo

The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in cough score was demonstrated. Cough score was assessed by means of ordinal categorical 4-point scales [0 = No cough, 1= Sporadic and mild cough, 2 = Moderate cough, 3 = Severe Cough] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionScore (Mean)
Change from baseline to Day 3Change from baseline to Day 7
N-Acetylcysteine-0.4-0.8
Placebo-0.5-0.6

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Change From Baseline to Day 3 and to Day 7 in Mean Expectoration Difficulty Score of Ambroxol Hydrochloride and Placebo

The superiority of the slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in expectoration difficulty score was demonstrated. Expectoration difficulty was assessed by ordinal categorical 4-point scales [0 = No difficulty, 1 = Mild difficulty, 2 = Moderate difficulty, 3 = Marked difficulty] with 0 = best and 3 = worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionScore (Mean)
Change from baseline to Day 3Change from baseline to Day 7
Ambroxol Hydrochloride-0.7-1.3
Placebo-0.7-1.1

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Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of NAC and Placebo

The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum color score was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionScore (Mean)
Change from baseline to Day 3Change from baseline to Day 7
N-Acetylcysteine-0.5-0.8
Placebo-0.5-0.8

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Change From Baseline to Day 3 and to Day 7 in Mean Sputum Viscosity Score of Ambroxol Hydrochloride and Placebo

The superiority of the slow intravenous infusion ambroxol hydrochloride to placebo in terms of change from baseline in sputum viscosity score was demonstrated. Sputum viscosity was assessed by ordinal categorical 4-point scales [0 = Liquid (normal viscosity), 1= Fluid (mildly increased viscosity), 2 = Viscous (moderately increased viscosity), 3 = Sticky (severely increased viscosity)] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionScore (Mean)
Change from baseline to Day 3Change from baseline to Day 7
Ambroxol Hydrochloride-0.6-1.2
Placebo-0.6-1.0

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Change From Baseline to Day 3 and to Day 7 in Mean Sputum Volume of Ambroxol Hydrochloride and Placebo

The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in mean sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionmL/24h (Mean)
Change from baseline to Day 3Change from baseline to Day 7
Ambroxol Hydrochloride-4.53-9.73
Placebo-4.14-7.39

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Change From Baseline to Day 3 and to Day 7 of Mean Sputum Volume of NAC and Placebo

The superiority of the slow intravenous infusion of NAC to placebo in terms of change from baseline in sputum volume was demonstrated. Patients collected 24-hour sputum (morning to same time of the following morning) in a graduated cup and volume was expressed as mL/24h. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionmL/24h (Mean)
Change from baseline to Day 3Change from baseline to Day 7
N-Acetylcysteine-1.601-9.405
Placebo-4.144-7.391

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Number of Participants With Adverse Events

The safety and tolerability of intravenous NAC 600 mg twice daily was demonstrated. (NCT03843541)
Timeframe: From screening to follow-up after the last administration of the investigational medicinal product (IMP) [assessed up to 19 months]

,,
InterventionParticipants (Count of Participants)
At least one AEAt least one TEAEAt least one IMP-related TEAEAt least one TEAE leading to drug withdrawalAt least one TEAE leading to drug interruptionAt least one TEAE leading to fatal outcomeAt least one severe TEAEAt least one TEAE of COVID-19At least one SAEAt least one TESAEAt least one TESAE leading to drug withdrawalAt least one TESAE leading to drug interruptionAt least one TESAE leading to fatal outcomeAt least one TESAE of COVID-19
Ambroxol Hydrochloride76661120040551000
N-Acetylcysteine82671150150221010
Placebo7158031070771100

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Change From Baseline to Day 3 and to Day 7 in Mean Sputum Color Score of Ambroxol Hydrochloride and Placebo

The superiority of slow intravenous infusion of ambroxol hydrochloride to placebo in terms of change from baseline in sputum color was demonstrated. Sputum color was assessed by means of ordinal categorical 4-point scales [0 = Mostly white, 1= Mostly pale yellow, 2 = Mostly dark yellow, 3 = Very dark yellow /green] with 0 = best and 3= worst. (NCT03843541)
Timeframe: From Baseline upto Day 3 and Day 7

,
InterventionScore (Mean)
Change from baseline to Day 3Change from baseline to Day 7
Ambroxol Hydrochloride-0.5-0.9
Placebo-0.5-0.8

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