Page last updated: 2024-12-04

benphothiamine

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Occurs in Manufacturing Related Drugs Related Conditions Protein Interactions Research Growth Market Indicators

Description

benfotiamine : A thioester that is a synthetic analogue of thiamine obtained by acylative cleavage of the thiazole ring and O-phospohorylation. [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]

Cross-References

ID SourceID
PubMed CID3032771
CHEMBL ID4303665
SCHEMBL ID188070
SCHEMBL ID19184708
MeSH IDM0061935
PubMed CID2320
CHEMBL ID3183549
CHEBI ID41039
MeSH IDM0061935

Synonyms (113)

Synonym
PRESTWICK_68
cas-22457-89-2
NCGC00016764-01
PRESTWICK3_000654
NCGC00179477-01
PRESTWICK2_000654
BPBIO1_000757
BSPBIO_000687
biotamin (tn)
D01255
benfotiamine (jan/inn)
s-[2-{[(4-amino-2-methylpyrimidin-5-yl)methyl](formyl)amino}-5-(phosphonooxy)pent-2-en-3-yl] benzenecarbothioate
s-[(z)-2-[(4-amino-2-methylpyrimidin-5-yl)methyl-formylamino]-5-phosphonooxypent-2-en-3-yl] benzenecarbothioate
HMS1570C09
HMS2097C09
(3z)-4-{n-[(4-amino-2-methylpyrimidin-5-yl)methyl]carbonylamino}-3-(phenylcarb onylthio)pent-3-enyl dihydrogen phosphate
dtxcid1025433
tox21_110597
AKOS015920320
CCG-220654
SCHEMBL188070
tox21_110597_1
NCGC00016764-04
STL453586
s-[(2z)-2-{[(4-amino-2-methylpyrimidin-5-yl)methyl](formyl)amino}-5-(phosphonooxy)pent-2-en-3-yl] benzenecarbothioate
s-{(1z)-2-[[(4-amino-2-methyl-5-pyrimidinyl)methyl](formyl)amino]-1-[2-(phosphonooxy)ethyl]-1-propenyl} benzenecarbothioate, aldrichcpr
SR-01000872627-1
AC-8280
SR-01000872627-2
sr-01000872627
SCHEMBL19184708
HMS3714C09
A15020
DB11748
775256-41-2
CHEMBL4303665
22457-89-2 (free acid)
(z)-s-(2-(n-((4-amino-2-methylpyrimidin-5-yl)methyl)formamido)-5-(phosphonooxy)pent-2-en-3-yl) benzothioate
s-{(1z)-2-[[(4-amino-2-methyl-5-pyrimidinyl)methyl](formyl)amino]-1-[2-(phosphonooxy)ethyl]-1-propenyl} benzenecarbothioate
{[(3z)-4-{n-[(4-amino-2-methylpyrimidin-5-yl)methyl]formamido}-3-[(z)-benzoylsulfanyl]pent-3-en-1-yl]oxy}phosphonic acid
EN300-21694383
DIVK1C_000187
KBIO1_000187
btmp
cb 8088
benfotiamine [inn:dcf:jan]
benzoylthiamine monophosphate
benzoylthiamine o-monophosphate
benzoic acid, thio-, s-ester with n-((4-amino-2-methyl-5-pyrimidinyl)methyl)-n-(4-hydroxy-2-mercapto-1-methyl-1-butenyl)formamide dihydrogen phosphate (ester)
einecs 245-013-4
biotamin
s-benzoylthiamine monophosphate
berdi
neurostop
tabiomyl
benfotiaminum [inn-latin]
brn 0771326
benfotiamina [inn-spanish]
nitanevril
benphothiamine
thiamine monophosphate benzoyl
vitanevril
n-((4-amino-2-methyl-5-pyrimidinyl)methyl)-n-(4-hydroxy-2-mercapto-1-methyl-1-butenyl)formamide s-benzoate o-phosphate
betivina
benfothiamine
8088 c.b
SPECTRUM_001388
22457-89-2
benfotiamine
s-benzoylthiamine o-monophosphate
KBIO2_004436
KBIO2_001868
KBIOGR_001424
KBIOSS_001868
KBIO3_002056
KBIO2_007004
PRESTWICK1_000654
NINDS_000187
SPECTRUM2_001525
SPECTRUM4_001072
SPECTRUM3_000958
SPBIO_002608
PRESTWICK0_000654
SPBIO_001310
SMP1_000041
nsc-758241
dtxsid3045433 ,
CHEBI:41039 ,
benfotiaminum
benfotiamina
unii-y92ous2h9b
nsc 758241
foti
y92ous2h9b ,
8088 c.b.
s-benzoylthiamine-o-monophosphate
FT-0630486
benfotiamine [who-dd]
benfotiamine [mi]
benzoylthiaminmonophosphat
benfotiamine [jan]
benfotiamine [mart.]
benfotiamine [inn]
benzenecarbothioic acid, s-(2-(((4-amino-2-methyl-5-pyrimidinyl)methyl)formylamino)-1-(2-(phosphonooxy)ethyl)-1-propen-1-yl) ester
benfotiamine [vandf]
8088cb
8088-cb
s-(2-(n-((4-amino-2-methylpyrimidin-5-yl)methyl)formamido)-5-(phosphonooxy)pent-2-en-3-yl) benzothioate
CHEMBL3183549
B4711
AKOS030239806
Q409953
D81796

Research Excerpts

Toxicity

ExcerptReferenceRelevance
"Both SAD and MAD studies of benfotiamine in healthy subjects were safe and well tolerated."( Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Benfotiamine in Healthy Subjects.
Cao, W; Chen, H; Chen, W; Li, H; Li, X; Lin, P; Liu, C; Sheng, L; Xu, H; Yang, M; Yuan, F; Zhong, C, 2021
)
0.62

Pharmacokinetics

ExcerptReferenceRelevance
" Due to its excellent pharmacokinetic profile benfotiamine should be preferred in treatment of relevant indications."( Pharmacokinetics of thiamine derivatives especially of benfotiamine.
Loew, D, 1996
)
0.29
"The pharmacokinetic parameters AUC0-24h, Cmax and tmax of the benfotiamin group in whole blood and plasma exceeded significantly those in the TN group."( Alteration of thiamine pharmacokinetics by end-stage renal disease (ESRD).
Bitsch, R; Frank, T; Maiwald, J; Stein, G, 1999
)
0.3
" This study investigated the pharmacokinetic profiles of thiamine and its phosphorylated metabolites after single- and multiple-dose administration of benfotiamine in healthy Chinese volunteers, and assessed the bioavailability of orally benfotiamine administration compared to thiamine hydrochloride."( Pharmacokinetic study of benfotiamine and the bioavailability assessment compared to thiamine hydrochloride.
Cheng, Z; Gu, Z; Guo, X; Li, S; Liu, X; Xie, F; Yu, P, 2014
)
0.4
" Although there are many publications on the pharmacokinetic (PK) properties of thiamine-containing products, no direct comparisons between these agents ."( Comparative Pharmacokinetic Analysis of Thiamine and Its Phosphorylated Metabolites Administered as Multivitamin Preparations.
Han, S; Hong, T; Lee, J; Lee, S; Park, G; Park, WS; Seo, Y; Youn, S, 2016
)
0.43

Bioavailability

ExcerptReferenceRelevance
"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
" Biokinetic data, measured as area under the curve and maximal concentration in plasma and hemolysate after ingestion, demonstrated a significantly improved bioavailability from the lipophilic derivative despite an ingested dose of only 40% as compared with the water-soluble salt."( Bioavailability assessment of the lipophilic benfotiamine as compared to a water-soluble thiamin derivative.
Bitsch, R; Grüneklee, D; Heuzeroth, L; Möller, J; Wolf, M, 1991
)
0.28
" All biokinetic data demonstrated a significantly improved thiamine bioavailability from benfotiamin compared with the other preparations."( Comparative bioavailability of various thiamine derivatives after oral administration.
Bitsch, R; Greb, A, 1998
)
0.3
"The bioavailability of thiamin mononitrate, thiamin chloride-hydrochloride and benfotiamin was compared in broiler chickens."( Bioavailability of water- and lipid-soluble thiamin compounds in broiler chickens.
Bitsch, I; Bitsch, R; Frank, T; Geyer, J; Hoppe, PP; Krämer, K; Netzel, M, 2000
)
0.31
"Lipid-soluble thiamine precursors have a much higher bioavailability than genuine thiamine and therefore are more suitable for therapeutic purposes."( Benfotiamine, a synthetic S-acyl thiamine derivative, has different mechanisms of action and a different pharmacological profile than lipid-soluble thiamine disulfide derivatives.
Bettendorff, L; Evrard, B; Gangolf, M; Piette, M; Plumier, JC; Seyen, S; Volvert, ML, 2008
)
0.35
" Thus, it may be concluded that benfotiamine reduces oxidative stress and activates endothelial nitric oxide synthase to enhance the generation and bioavailability of NO and subsequently improves the integrity of vascular endothelium to prevent sodium arsenite-induced experimental VED."( The defensive effect of benfotiamine in sodium arsenite-induced experimental vascular endothelial dysfunction.
Balakumar, P; Reddy, K; Verma, S, 2010
)
0.36
" Due to the low bioavailability of the hydrosolubile forms of thiamine, its liposolubile preparations (benfotiamine) are preferentially used."( [The effect of benfothiamine in the therapy of diabetic polyneuropathy].
Apostolski, S; Basta, I; Kacar, A; Lavrnić, D; Nikolić, A,
)
0.13
" Here, we tested the effect of benfotiamine, a thiamine derivative with better bioavailability than thiamine, on cognitive impairment and pathology alterations in a mouse model of Alzheimer's disease, the amyloid precursor protein/presenilin-1 transgenic mouse."( Powerful beneficial effects of benfotiamine on cognitive impairment and beta-amyloid deposition in amyloid precursor protein/presenilin-1 transgenic mice.
Chen, J; Dong, W; Fei, G; Gong, N; Gu, F; Pan, X; Qin, Y; Sun, X; Xu, TL; Xu, Z; Yu, M; Yu, Z; Zhao, J; Zhao, L; Zhong, C, 2010
)
0.36
" Thus, we verified the high bioavailability especially of benfotiamine within 6h of ethanol administration."( Liver, plasma and erythrocyte levels of thiamine and its phosphate esters in rats with acute ethanol intoxication: a comparison of thiamine and benfotiamine administration.
Jordao, AA; Portari, GV; Vannucchi, H, 2013
)
0.39
" This study investigated the pharmacokinetic profiles of thiamine and its phosphorylated metabolites after single- and multiple-dose administration of benfotiamine in healthy Chinese volunteers, and assessed the bioavailability of orally benfotiamine administration compared to thiamine hydrochloride."( Pharmacokinetic study of benfotiamine and the bioavailability assessment compared to thiamine hydrochloride.
Cheng, Z; Gu, Z; Guo, X; Li, S; Liu, X; Xie, F; Yu, P, 2014
)
0.4
" We aimed to compare the PK profiles of these lipophilic thiamine derivatives and to compare the extent of the increase in bioavailability to that of naïve thiamine."( Comparative Pharmacokinetic Analysis of Thiamine and Its Phosphorylated Metabolites Administered as Multivitamin Preparations.
Han, S; Hong, T; Lee, J; Lee, S; Park, G; Park, WS; Seo, Y; Youn, S, 2016
)
0.43
" The present data suggest that thiamine precursors with high bioavailability might be useful as a complementary therapy in several neuropsychiatric disorders."( Thiamine and benfotiamine prevent stress-induced suppression of hippocampal neurogenesis in mice exposed to predation without affecting brain thiamine diphosphate levels.
Anthony, DC; Bazhenova, N; Bettendorff, L; Caron, N; Coumans, B; Gorlova, A; Lakaye, B; Malgrange, B; Markova, N; Pavlov, D; Sambon, M; Shevtsova, E; Strekalova, T; Svistunov, A; Vignisse, J; Wins, P, 2017
)
0.46
" However, slower absorption and reduced bioavailability is a major limiting factor for its clinical use."( Therapeutic potential of benfotiamine and its molecular targets.
Belur, PD; Howarth, FC; Ojha, S; Raj, V; Subramanya, SB, 2018
)
0.48
" Though a promising nutraceutical approach for cancer therapy, thiamine's low bioavailability may limit clinical effectiveness."( Thiamine mimetics sulbutiamine and benfotiamine as a nutraceutical approach to anticancer therapy.
Bartlett, MG; Byrnes, CC; Jonus, HC; Kim, J; Said, HM; Valle, ML; Zastre, JA, 2020
)
0.56
" In order to compensate thiamine deficiency, several thiamine precursors with higher bioavailability were developed since the 1950s."( Neuroprotective Effects of Thiamine and Precursors with Higher Bioavailability: Focus on Benfotiamine and Dibenzoylthiamine.
Bettendorff, L; Sambon, M; Wins, P, 2021
)
0.62
" Currently, there are only few pathogenetically oriented pharmacotherapies for DSPN, one of which is benfotiamine, a prodrug of thiamine with a high bioavailability and favourable safety profile."( BOND study: a randomised double-blind, placebo-controlled trial over 12 months to assess the effects of benfotiamine on morphometric, neurophysiological and clinical measures in patients with type 2 diabetes with symptomatic polyneuropathy.
Al-Hasani, H; Bönhof, GJ; Herder, C; Icks, A; Knebel, B; Kuss, O; Reule, C; Roden, M; Sipola, G; Strassburger, K; Strom, A; Wollmann, JC; Ziegler, D, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Occurs in Manufacturing (21 Product(s))

Product Categories

Product CategoryProducts
Vitamins & Supplements15
Professional Supplements6

Products

ProductBrandCategoryCompounds Matched from IngredientsDate Retrieved
Country Life Benfotiamine with Thiamin -- 150 mg - 60 Vegetarian CapsulesCountry LifeVitamins & SupplementsBenfotiamine, Thiamin2024-11-29 10:47:42
Designs for Sport Multi + Phyto - NSF Certified for Sport -- 120 Vegetarian CapsulesDesigns for SportProfessional SupplementsVitamin C, Benfotiamine, Biotin, Boron, Chromium, Folate, Lycopene, Manganese, MK-7, MK-9, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Trans-Resveratrol, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Designs for Sport Power Pack - NSF Certified for Sport -- 30 PacketsDesigns for SportProfessional SupplementsVitamin C, Benfotiamine, Biotin, Boron, Chromium, Folate, Lycopene, Manganese, MK-7, MK-9, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Quercetin, Trans-Resveratrol, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Douglas Laboratories Ultra Benfotiamine -- 60 Vegetarian CapsulesDouglas LaboratoriesProfessional SupplementsBenfotiamine, Pyridoxal 5' Phosphate2024-11-29 10:47:42
Dr. Mercola Vitamin B Complex with Benfotiamine -- 180 CapsulesDr. MercolaProfessional SupplementsBenfotiamine, Biotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Dr. Mercola Vitamin B Complex with Benfotiamine -- 60 CapsulesDr. MercolaProfessional SupplementsBenfotiamine, Biotin, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Force Factor Benfotiamine -- 250 mg - 90 Vegetable CapsulesForce FactorVitamins & SupplementsBenfotiamine, Thiamin2024-11-29 10:47:42
Futurebiotics Benfotiamine -- 150 mg - 120 Vegetarian CapsulesFuturebioticsVitamins & SupplementsBenfotiamine2024-11-29 10:47:42
Life Extension Mega Benfotiamine -- 250 mg - 120 Vegetarian CapsulesLife ExtensionVitamins & SupplementsBenfotiamine, Thiamine2024-11-29 10:47:42
LivOn Laboratories Lypo-Spheric™ B-Complex plus -- 30 PacketsLivOn LaboratoriesVitamins & SupplementsBenfotiamine, Biotin, Boron, Chromium, Folate, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Selenium, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
MenoLabs MenoFit® Menopause Probiotic for Healthy Weight -- 60 CapsulesMenoLabsVitamins & SupplementsL-5-methyltetrahydrofolate, Vitamin C, Benfotiamine, Vitamin D3, Folate, Vitamin K2, Vitamin K2, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
MenoLabs Menoglow Menopause Probiotic for Signs of Aging -- 60 CapsulesMenoLabsVitamins & SupplementsVitamin C, Benfotiamine, Vitamin D3, Folate, Vitamin K2, Vitamin K2, Vitamin B6, Riboflavin, Vitamin B12, Vitamin B62024-11-29 10:47:42
Momentous Essential Multivitamin - NSF Certified for Sport - 30 Servings -- 120 Vegetarian CapsulesMomentousProfessional SupplementsVitamin C, Benfotiamine, Biotin, Boron, Chromium, Folate, microcrystalline cellulose, Lycopene, Manganese, MK-7, MK-9, Molybdenum, Niacin, Pantethine, Pantothenic Acid, Vitamin B6, Quercetin, Trans-Resveratrol, Vitamin A, Riboflavin, Selenium, Thiamin, Vanadium, Vitamin B12, Vitamin B6, Vitamin K2024-11-29 10:47:42
Source Naturals Benfotiamine -- 150 mg - 120 TabletsSource NaturalsVitamins & SupplementsBenfotiamine, Dibasic calcium phosphate, microcrystalline cellulose, stearic acid, Thiamine2024-11-29 10:47:42
Terry Naturally Clinical Essentials Multi-Vitamin & Minerals -- 60 TabletsTerry NaturallyVitamins & SupplementsPABA, citric acid, Vitamin C, Benfotiamine, Biotin, Boron, calcium ascorbate, calcium fructoborate, dicalcium phosphate, Vitamin D3, Choline, Chromium, citric acid, Vitamin E, Folate, Vitamin E, glycerol monostearate, glycine, Microcrystalline cellulose, Inositol, Iodine, maltodextrin, Manganese, Molybdenum, Niacin, PABA, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Vanadium, Vitamin B12, Vitamin B62024-11-29 10:47:42
Terry Naturally Healthy Feet & Nerves™ -- 120 CapsulesTerry NaturallyVitamins & SupplementsBenfotiamine, Biotin, Chromium, Folate, cellulose powder, Niacin, Pantothenic Acid, Vitamin B6, Riboflavin, Thiamin, Alpha-Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitacost-Synergy Benfotiamine -- 150 mg - 120 CapsulesVitacost-SynergyVitamins & SupplementsBenfotiamine, cellulose2024-11-29 10:47:42
Vitacost-Synergy Mitochondrial Energy Booster† 15-Nutrient Blend -- 120 CapsulesVitacost-SynergyVitamins & SupplementsBenfotiamine, cholecalciferol, Chromium, Coenzyme Q10, Vitamin E, Vitamin E, microcrystalline cellulose, D3, Niacin, Vitamin B6, Riboflavin, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Vitacost-Synergy Twice Daily Energy† Multivitamin -- 60 CapsulesVitacost-SynergyVitamins & SupplementsVitamin C, Benfotiamine, Biotin, cholecalciferol, Chromium, Coenzyme Q10, Vitamin E, Folate, Vitamin E, Iodine, Lutein, Manganese, Vitamin K2, Menaquinone-7, Vitamin K2, Molybdenum, Niacin, Pantothenic Acid, Vitamin B6, Vitamin A, Riboflavin, Selenium, Thiamin, Alpha Lipoic Acid, Vitamin B12, Vitamin B6, phytonadione, Vitamin K, Zeaxanthin2024-11-29 10:47:42
Zahler B-Complex Bioactive B Complex Formula -- 60 Time Release TabletsZahlerVitamins & SupplementsBenfotiamine, Biotin, Dicalcium phosphate, Choline, Folate, microcrystalline cellulose, Inositol, Niacin, Pantethine, Vitamin B6, Riboflavin, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42
Zahler B-Complex Bioactive B-Complex Formula -- 120 Time Release TabletsZahlerVitamins & SupplementsBenfotiamine, Biotin, Dicalcium phosphate, Choline, Folate, microcrystalline cellulose, Inositol, Niacin, Pantethine, Vitamin B6, Riboflavin, stearic acid, Vitamin B12, Vitamin B62024-11-29 10:47:42

Roles (5)

RoleDescription
immunological adjuvantA substance that augments, stimulates, activates, potentiates, or modulates the immune response at either the cellular or humoral level. A classical agent (Freund's adjuvant, BCG, Corynebacterium parvum, et al.) contains bacterial antigens. It could also be endogenous (e.g., histamine, interferon, transfer factor, tuftsin, interleukin-1). Its mode of action is either non-specific, resulting in increased immune responsiveness to a wide variety of antigens, or antigen-specific, i.e., affecting a restricted type of immune response to a narrow group of antigens. The therapeutic efficacy is related to its antigen-specific immunoadjuvanticity.
nutraceuticalA product in capsule, tablet or liquid form that provide essential nutrients, such as a vitamin, an essential mineral, a protein, an herb, or similar nutritional substance.
antioxidantA substance that opposes oxidation or inhibits reactions brought about by dioxygen or peroxides.
provitamin B1A provitamin that can be converted into vitamin B1 by enzymes from animal tissues.
protective agentSynthetic or natural substance which is given to prevent a disease or disorder or are used in the process of treating a disease or injury due to a poisonous agent.
[role 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]

Drug Classes (4)

ClassDescription
aminopyrimidineA member of the class of pyrimidines that is pyrimidine substituted by at least one amino group and its derivatives.
formamidesAmides with the general formula R(1)R(2)NCHO (R(1) and R(2) can be H).
organic phosphate
thioesterA compound of general formula RC(=O)SR'. Compare with thionoester, RC(=S)OR'.
[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 (4)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
RAR-related orphan receptor gammaMus musculus (house mouse)Potency1.67850.006038.004119,952.5996AID1159521
AR proteinHomo sapiens (human)Potency8.91960.000221.22318,912.5098AID743036; AID743040; AID743042; AID743053; AID743054
glucocorticoid receptor [Homo sapiens]Homo sapiens (human)Potency11.23980.000214.376460.0339AID720691; AID720719
cytochrome P450, family 19, subfamily A, polypeptide 1, isoform CRA_aHomo sapiens (human)Potency8.04140.001723.839378.1014AID743083
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (36)

Assay IDTitleYearJournalArticle
AID1347098qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-SH cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347099qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB1643 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347425Rhodamine-PBP qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
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.
AID1347154Primary screen GU AMC 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.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1347107qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh30 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347101qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-12 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347105qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for MG 63 (6-TG R) cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347103qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for OHS-50 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347089qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for TC32 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347083qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: Viability assay - alamar blue signal for LASV Primary Screen2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347086qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lymphocytic Choriomeningitis Arenaviruses (LCMV): LCMV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347100qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for LAN-5 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347094qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for BT-37 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347092qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for A673 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347407qHTS to identify inhibitors of the type 1 interferon - major histocompatibility complex class I in skeletal muscle: primary screen against the NCATS Pharmaceutical Collection2020ACS chemical biology, 07-17, Volume: 15, Issue:7
High-Throughput Screening to Identify Inhibitors of the Type I Interferon-Major Histocompatibility Complex Class I Pathway in Skeletal Muscle.
AID1347082qHTS for Inhibitors of the Functional Ribonucleoprotein Complex (vRNP) of Lassa (LASV) Arenavirus: LASV Primary Screen - GLuc reporter signal2020Antiviral research, 01, Volume: 173A cell-based, infectious-free, platform to identify inhibitors of lassa virus ribonucleoprotein (vRNP) activity.
AID1347108qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh41 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347096qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for U-2 OS cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347091qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SJ-GBM2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347106qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for control Hh wild type fibroblast cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID651635Viability Counterscreen for Primary qHTS for Inhibitors of ATXN expression
AID1347093qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for SK-N-MC cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347090qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for DAOY cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347095qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for NB-EBc1 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347097qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Saos-2 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1745845Primary qHTS for Inhibitors of ATXN expression
AID1347104qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for RD cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347102qHTS of pediatric cancer cell lines to identify multiple opportunities for drug repurposing: Primary screen for Rh18 cells2018Oncotarget, Jan-12, Volume: 9, Issue:4
Quantitative high-throughput phenotypic screening of pediatric cancer cell lines identifies multiple opportunities for drug repurposing.
AID1347424RapidFire Mass Spectrometry qHTS Assay for Modulators of WT P53-Induced Phosphatase 1 (WIP1)2019The Journal of biological chemistry, 11-15, Volume: 294, Issue:46
Physiologically relevant orthogonal assays for the discovery of small-molecule modulators of WIP1 phosphatase in high-throughput screens.
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.
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.
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.
AID540299A screen for compounds that inhibit the MenB enzyme of Mycobacterium tuberculosis2010Bioorganic & medicinal chemistry letters, Nov-01, Volume: 20, Issue:21
Synthesis and SAR studies of 1,4-benzoxazine MenB inhibitors: novel antibacterial agents against Mycobacterium tuberculosis.
AID588519A screen for compounds that inhibit viral RNA polymerase binding and polymerization activities2011Antiviral research, Sep, Volume: 91, Issue:3
High-throughput screening identification of poliovirus RNA-dependent RNA polymerase inhibitors.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (161)

TimeframeStudies, This Drug (%)All Drugs %
pre-19902 (1.24)18.7374
1990's15 (9.32)18.2507
2000's49 (30.43)29.6817
2010's70 (43.48)24.3611
2020's25 (15.53)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 47.30

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 strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index47.30 (24.57)
Research Supply Index5.31 (2.92)
Research Growth Index5.58 (4.65)
Search Engine Demand Index148.13 (26.88)
Search Engine Supply Index4.00 (0.95)

This Compound (47.30)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials0 (0.00%)5.53%
Trials40 (24.84%)5.53%
Reviews0 (0.00%)6.00%
Reviews19 (11.80%)6.00%
Case Studies0 (0.00%)4.05%
Case Studies3 (1.86%)4.05%
Observational0 (0.00%)0.25%
Observational0 (0.00%)0.25%
Other12 (100.00%)84.16%
Other99 (61.49%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (12)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Role of the Glucosamine Pathway and Reactive Oxygen Species in the Pathogenesis of Diabetic Complications [NCT00703989]21 participants (Actual)Interventional2005-02-28Completed
Benfotiamine Effect on Advanced Glycation End Products(AGEs) and Soluble Receptors for AGEs(sRAGE) in Type 2 Diabetes Mellitus. [NCT02772926]41 participants (Actual)Interventional2015-10-31Completed
The Effectiveness of Benfotiamine in Reducing Abusive Drinking Among Family History Positive and Negative Alcoholics [NCT00680121]Phase 4120 participants (Actual)Interventional2008-07-31Completed
Benfotiamine Prevents Vascular Dysfunction in Healthy Smokers [NCT00785460]Phase 320 participants (Actual)Interventional2008-01-31Completed
A Double-Blind Clinical Trial of Benfotiamine Treatment in Diabetic Nephropathy [NCT00565318]Phase 486 participants (Anticipated)Interventional2007-12-31Completed
Observational Study of Effectiveness and Safety of Add-on Milgamma® and Milgamma® Compositum Step-Therapy in Routine Practice of Management of Adult Patients With Acute Non-Specific Low Back Pain Receiving Modern NSAIDs [NCT03892707]500 participants (Actual)Observational2018-12-15Completed
Effects of Benfotiamine on Intraepidermal Nerve Fiber Density (IENFD)and Diabetic Neuropathy in Subjects With Sensorimotor Diabetic Polyneuropathy: a Double-blind, Randomized, Placebo-controlled Parallel Group Pilot Study Over 12 Months. [NCT01868191]Phase 322 participants (Anticipated)Interventional2013-07-31Not yet recruiting
Effects of a Chronical Treatment With Benfotiamine in People With Type 2 Diabetes Mellitus on Pre- and Postprandial Endothelial Function, as Well as on the Function of the Autonomic Nervous System [NCT00446810]Phase 430 participants (Anticipated)Interventional2007-09-30Recruiting
Acute Effects of a Low-AGE vs. High-AGE Meal on Postprandial Endothelial Function in People With Type 2 Diabetes Mellitus. Protective Effects of Benfotiamine [NCT00437008]Phase 421 participants Interventional2004-11-30Completed
Can Oral Benfotiamine Supplementation Influence Progression of Microvascular Complications in Patients With Type 1 Diabetes? [NCT00117026]Phase 1/Phase 267 participants (Actual)Interventional2005-08-31Completed
A Combined Phase 1 + 2 Clinical Trial Evaluating the Safety and Efficacy of BC-DN-01 in the Treatment of Painful Diabetic Peripheral Neuropathy [NCT01793350]Phase 1/Phase 20 participants (Actual)Interventional2013-06-30Withdrawn
Benfotiamine in Alzheimer's Disease: A Pilot Study [NCT02292238]Phase 271 participants (Actual)Interventional2015-02-15Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00680121 (4) [back to overview]Alcoholism Severity Scale
NCT00680121 (4) [back to overview]Barrett Impulsivity Scale: Total Impulsiveness
NCT00680121 (4) [back to overview]Change in Average Daily Alcohol Consumption
NCT00680121 (4) [back to overview]Symptom Checklist-90 (SCL-90): Global Severity Index
NCT02292238 (6) [back to overview]Change From Baseline in ADAS-Cog Score
NCT02292238 (6) [back to overview]Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score
NCT02292238 (6) [back to overview]Change From Baseline in Brain Glucose Utilization
NCT02292238 (6) [back to overview]Change From Baseline in Buschke Selective Reminding Test (SRT) Score
NCT02292238 (6) [back to overview]Change From Baseline in Clinical Dementia Rating (CDR) Score
NCT02292238 (6) [back to overview]Change From Baseline in Neuropsychiatric Inventory (NPI) Score
NCT03892707 (11) [back to overview]Change in Pain-related Disability After 10 Days of Treatment
NCT03892707 (11) [back to overview]Change of Pain Intensity After 10 Days of Treatment
NCT03892707 (11) [back to overview]Change of Pain Intensity Over Time
NCT03892707 (11) [back to overview]Number of Treatment Days With NSAIDs
NCT03892707 (11) [back to overview]Percentage of Patients With at Least One Pain Flare-up During the Study
NCT03892707 (11) [back to overview]Change of Pain Intensity After 5, 24 and 38 Days of Treatment
NCT03892707 (11) [back to overview]Patient Satisfaction With Treatment
NCT03892707 (11) [back to overview]Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.
NCT03892707 (11) [back to overview]Percentage of Patients With at Least One Pain Flare-up Resulting in Consultancy With Physician, Resulting in Disruption of Daily Activity, and Resulting in NSAIDs Intake
NCT03892707 (11) [back to overview]Prescribed and Actual Number of Milgamma® Injections
NCT03892707 (11) [back to overview]Prescribed and Actual Number of Treatment Days With Milgamma® Compositum

Alcoholism Severity Scale

The alcoholism severity scale measures the severity of a person's dependence to alcohol. The scale ranges from a score of 0 (least severe) to 33 (most severe). The higher the score the worse the dependence. (NCT00680121)
Timeframe: 6 Months

Interventionscores on a scale (Mean)
Control Group14.0
Benfotiamine10.7

[back to top]

Barrett Impulsivity Scale: Total Impulsiveness

Scale measures impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness). Items are scored on a 4 point scale with 1 point equaling rarely/never up to 4 points equaling almost always/always. Total impulsivity score ranges from 30 (least impulsive) to 120 (most impulsive). The higher the score the higher the level of impulsiveness. (NCT00680121)
Timeframe: 6 Months

Interventionscores on a scale (Mean)
Control Group65.0
Benfotiamine65.4

[back to top]

Change in Average Daily Alcohol Consumption

measured as standard drinks of alcohol per day (SD/day) (NCT00680121)
Timeframe: Change from Baseline to 6 Months

Interventionalcoholic drinks per day (Mean)
Control Group-3.4
Benfotiamine-3.0

[back to top]

Symptom Checklist-90 (SCL-90): Global Severity Index

The SCL-90 is a brief multidimensional self-report inventory that screens for nine symptoms of psychopathology and provides three global distress indicators. It provides an overview of symptom severity and intensity. The outcome measures psychiatric symptoms using a 30-item scale reported as t-scores relative to a normative population. (NCT00680121)
Timeframe: 6 Months

Interventiont-score (Mean)
Control Group1.02
Benfotiamine1.04

[back to top]

Change From Baseline in ADAS-Cog Score

"The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) is a brief neuropsychological assessment used to assess the severity of cognitive symptoms of dementia. It is one of the most widely used cognitive scales in clinical trials and is considered to be the gold standard for assessing antidementia treatments. The ADAS-Cog range from 0 to 70, where higher scores indicate greater cognitive dysfunction." (NCT02292238)
Timeframe: Baseline, 1 year

Interventionscore on a scale (Mean)
Benfotiamine1.39
Placebo3.26

[back to top]

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) Score

Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) is a caregiver-based Activities of Daily Living (ADL) scale composed of 23 items developed for use in dementia clinical studies. It was designed to assess the patient's performance of both basic and instrumental activities of daily living such as those necessary for personal care, communicating and interacting with other people, maintaining a household, conducting hobbies and interests, as well as making judgments and decisions. The range for the total ADCS-ADL score is 0 to 78. Higher scores equate with higher functioning. (NCT02292238)
Timeframe: Baseline, 1 year

Interventionscore on a scale (Mean)
Benfotiamine-1.931
Placebo-3.16129

[back to top]

Change From Baseline in Brain Glucose Utilization

The AAL (Automatic Anatomical Labeling) atlas provides the taxonomy for 116 regions of interest, 90 of which capture non-cerebellar cortical regions. Signal averages from 9 cerebellar regions from each hemisphere were further averaged into one composite cerebellar region for each hemisphere, 'Cerebellum_L' and 'Cerebellum_R', which were comprised of the respective laterality averages of the regions: 'Cerebellum_Crus1 ' 'Cerebellum_Crus2 'Cerebellum_3' 'Cerebellum_4_5' 'Cerebellum_6' 'Cerebellum_7b' 'Cerebellum_8' 'Cerebellum_9' 'Cerebellum_10 '. Subsequently, these two composite regions are further combined with the bilateral paracentral lobules to provide one final composite for reference scaling. Concretely, the values from 'Cerebellum_L', 'Cerebellum_R', 'Paracentral_Lobule_L', and 'Paracentra_Lobule_R' were averaged. This final composite will serve as the denominator for the scaling operation of any ROI value prior to group-level analysis. (NCT02292238)
Timeframe: Baseline, 1 year

Interventionratio (Mean)
Benfotiamine-0.02
Placebo-0.01

[back to top]

Change From Baseline in Buschke Selective Reminding Test (SRT) Score

The SRT is a standard diagnostic tool in the assessment of verbal memory. The Buschke SRT immediate total scores are compared between treated (benfotiamine) and control (placebo) groups. The immediate total score is the sum of correct responses over the 6 learning trials with scores ranging from 0 to 72. A score of 0 means severe impairment in memory. A score of 72 means there is no impairment in memory. For the purpose of determining effect over several trials between groups, the fractional change from the baseline of each group is compared. (NCT02292238)
Timeframe: Baseline, 1 year

Interventionscore on a scale (Mean)
Benfotiamine0.86
Placebo-1.12

[back to top]

Change From Baseline in Clinical Dementia Rating (CDR) Score

The CDR was developed primarily for use in persons with dementia of the Alzheimer type (the equivalent of probable Alzheimer's Disease) and can also be used to stage dementia in other illnesses as well. The scores for the multiple items are summarized in one score. The CDR examines 6 categories of cognitive functioning domains. Each domain is scored on a scale ranging from 0 to 3 (including 0.5). A CDR-SB was generated as the sum of the values in each of the 6 domains. The CDR-SB sum scores range from 0 to 18, with higher scores indicating greater cognitive impairment and a 1 point worsening is considered a clinically significant symptom change. (NCT02292238)
Timeframe: Baseline, 1 year

Interventionscore on a scale (Mean)
Benfotiamine0.05
Placebo0.22

[back to top]

Change From Baseline in Neuropsychiatric Inventory (NPI) Score

The NPI assesses a wide range of behaviors encountered in dementia patients to provide a means of distinguishing frequency and severity of behavioral changes. Ten behavioral and two neuro-vegetative domains are evaluated through an interview with the caregiver. The total score ranges from 0 to 144. Higher scores suggest greater psychiatric impairment. (NCT02292238)
Timeframe: Baseline, 1 year

Interventionscore on a scale (Mean)
Benfotiamine6.69
Placebo9.23

[back to top] [back to top]

Change of Pain Intensity After 10 Days of Treatment

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline and at 10 days after the start of treatment. (NCT03892707)
Timeframe: Baseline; Visit 3 (10 days after the start of treatment)

Interventionunits on a scale (Mean)
NSAIDs Group-5.1
NSAIDs+Milgamma+Milgamma Compositum Group-4.0

[back to top]

Change of Pain Intensity Over Time

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline, at 5, 10, 24 and 38 days after the start of treatment. A mixed model repeated measures was used to analyze change from baseline in pain intensity over time from Baseline to Visit 5 (38 days after the start of treatment) in each group. The model included a random effect for subject and fixed effect terms for treatment, visit, treatment-by-visit interaction, baseline pain intensity. An unstructured covariance structure was used to model the within-subject errors. P-value was calculated for the difference between treatment groups. (NCT03892707)
Timeframe: From Baseline to Visit 5 (38 days after the start of treatment)

Interventionunits on a scale (Least Squares Mean)
NSAIDs Group-5.1
NSAIDs+Milgamma+Milgamma Compositum Group-4.4

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Number of Treatment Days With NSAIDs

Number of treatment days with NSAIDs was calculated using the data collected on the NSAIDs intake during the study irrespective of the specific drug used. Duration of each intake period was determined as Stop date - Start date +1 and, finally, all individual duration values were summed up. In case medication intake was ongoing at the End of Study Visit, stop date was imputed by the date of study completion. (NCT03892707)
Timeframe: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit

InterventionDays of treatment (Mean)
NSAIDs Group9.6
NSAIDs+Milgamma+Milgamma Compositum Group10.6

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Percentage of Patients With at Least One Pain Flare-up During the Study

Episode of pain flare-up was defined as presence of at least 1 day with low back pain following a period without pain lasting at least 4 weeks. Therefore pain flare-ups were registered no earlier than 4 weeks after the start of treatment, i.e. starting from Visit 5 (38 days after the start of treatment). The occurrence of pain flare-up was determined by the investigator. (NCT03892707)
Timeframe: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

InterventionParticipants (Count of Participants)
NSAIDs Group35
NSAIDs+Milgamma+Milgamma Compositum Group10

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Change of Pain Intensity After 5, 24 and 38 Days of Treatment

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Pain intensity was measured at baseline, at 5, 24 and 38 days after the start of treatment.Changes of pain intensity from baseline to Day 5, from baseline to Day 24 and from baseline to Day 38 after the start of treatment were calculated separately. (NCT03892707)
Timeframe: Baseline; Visit 2 (5 days after the start of treatment), Visit 4 (24 days after the start of treatment); Visit 5 (38 days after the start of treatment)

,
Interventionunits on a scale (Mean)
Change of pain intensity from baseline to Day 5 after the start of treatmentChange of pain intensity from baseline to Day 24 after the start of treatmentChange of pain intensity from baseline to Day 38 after the start of treatment
NSAIDs Group-3.1-6.1-6.3
NSAIDs+Milgamma+Milgamma Compositum Group-2.4-5.3-6.0

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Patient Satisfaction With Treatment

Patient satisfaction with treatment was evaluated using a 5-point verbal rating scale (1= very dissatisfied, 2= dissatisfied, 3= neutral, 4= satisfied, 5= very satisfied) after 5, 10, 38 days and 3 months (94 days) since the start of treatment. (NCT03892707)
Timeframe: Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 5 (38 days after the start of treatment) and Visit 9 (94 days after the start of treatment)

,
Interventionunits on a scale (Mean)
Visit 2 (5 days after the start of treatment)Visit 3 (10 days after the start of treatment)Visit 5 (38 days after the start of treatment)Visit 9 (94 days after the start of treatment)
NSAIDs Group3.84.24.54.6
NSAIDs+Milgamma+Milgamma Compositum Group3.84.14.54.7

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Percentage of Patients With 30% Low Back Pain Relief After 5, 10, 24 and 38 Days of Treatment.

Pain intensity was measured using 0-10 point Numeric Rating Scale (NRS). NRS is 11-step scale for assessment of pain intensity at the moment of patient's examination ranging from 0 (no pain) to 10 (worst pain imaginable). Relief in pain intensity was defined as 100%*(pain intensity at baseline - pain intensity at Visit 2, 3, 4 or 5)/ pain intensity at baseline. Percentage of patients showing at least 30% low back pain relief at Visit 2 (5 days after the start of treatment), at Visit 3 (10 days after the start of treatment), at Visit 4 (24 days after the start of treatment) and at Visit 5 (38 days after the start of treatment) were calculated separately. (NCT03892707)
Timeframe: Visit 2 (5 days after the start of treatment); Visit 3 (10 days after the start of treatment); Visit 4 (24 days after the start of treatment) and Visit 5 (38 days after the start of treatment)

,
InterventionParticipants (Count of Participants)
Number and percentage of patients with 30% pain relief at Day 5 after the start of treatmentNumber and percentage of patients with 30% pain relief at Day 10 after the start of treatmentNumber and percentage of patients with 30% pain relief at Day 24 after the start of treatmentNumber and percentage of patients with 30% pain relief at Day 38 after the start of treatment
NSAIDs Group194235241244
NSAIDs+Milgamma+Milgamma Compositum Group140214240241

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Percentage of Patients With at Least One Pain Flare-up Resulting in Consultancy With Physician, Resulting in Disruption of Daily Activity, and Resulting in NSAIDs Intake

"Episode of pain flare-up was defined as presence of at least 1 day with low back pain following a period without pain lasting at least 4 weeks. Therefore pain flare-ups were registered no earlier than 4 weeks after the start of treatment, i.e. starting from Visit 5 (38 days after the start of treatment). The occurrence of pain flare-up was determined by the investigator.~Percentages of patients with at least one pain flare-up resulting in consultancy with physician or professional management, resulting in disruption of daily activity, and resulting in NSAIDs intake were analyzed separately." (NCT03892707)
Timeframe: From Visit 5 (38 days after the start of treatment) to Visit 9 (End of Study Visit, 94 days after the start of treatment)

,
InterventionParticipants (Count of Participants)
Patients with at least one pain flare-up resulting in consultancy with physicianPatients with at least one pain flare-up resulting in disruption of daily activityPatients with at least one pain flare-up resulting in NSAIDs intake
NSAIDs Group42019
NSAIDs+Milgamma+Milgamma Compositum Group448

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Prescribed and Actual Number of Milgamma® Injections

Prescribed number of Milgamma® injections was reported at Baseline visit. Actual number of injections was calculated by counting the number of injections administered and reported starting from Visit 2. If the treatment was interrupted, the days patient did not receive Milgamma® injections were not contribute to the total number of injections. (NCT03892707)
Timeframe: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit

Interventionnumber of injections (Mean)
Prescribed exposure of Milgamma® injectionsActual exposure of Milgamma® injections
NSAIDs+Milgamma+Milgamma Compositum Group9.39.3

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Prescribed and Actual Number of Treatment Days With Milgamma® Compositum

Prescribed number of treatment days with Milgamma® compositum intake was reported at Baseline visit. Actual number of treatment days was calculated by summing up all the individual periods of treatment with Milgamma® compositum (in days) reported starting from Visit 2. If the treatment was interrupted, the days patient did not receive Milgamma® compositum were not contribute to the total number of treatment days with Milgamma® compositum intake. (NCT03892707)
Timeframe: From Baseline to Visit 9 (End of Study Visit, 94 days after the start of treatment)/ Early Discontinuation Visit

InterventionDays of treatment (Mean)
Prescribed exposure of Milgamma® compositumActual exposure of Milgamma® compositum
NSAIDs+Milgamma+Milgamma Compositum Group30.129.9

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