niacinamide and Blood Poisoning studies

nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.

Research Excerpts

Excerpt	Relevance	Reference
"Although both reached severe aplasia of the bone marrow without blastic infiltration, death occurred with neutropenic sepsis."	2.52	Hypertension and Life-Threatening Bleeding in Children with Relapsed Acute Myeloblastic Leukemia Treated with FLT3 Inhibitors. ( Aydınok, Y; Balkan, C; Karadaş, N; Kavaklı, K; Önder Siviş, Z; Yılmaz Karapınar, D, 2015)
" These results demonstrate that RJX-P and RJX-B are bioequivalent relative to their pharmacodynamic effects on tissue SOD and ascorbic acid levels."	1.62	Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix (RJX). ( Orhan, C; Ozercan, IH; Powell, J; Sahin, E; Sahin, K; Uckun, FM; Volk, M, 2021)
"Sepsis is a common clinical critical disease, which is one of the main causes of septic shock and multiple organ dysfunction syndrome (MODS)."	1.56	[Progress of nicotinamide in preventing infection and sepsis]. ( Chen, T; Cheng, L; Liang, H; Liu, K; Liu, Y, 2020)
"Sepsis-caused multiple organ failure remains the major cause of morbidity and mortality in intensive care units."	1.48	Administration of nicotinamide riboside prevents oxidative stress and organ injury in sepsis. ( Fan, GC; Hong, G; Lu, Z; Ni, R; Peng, T; Wang, G; Zhang, L; Zheng, D, 2018)
"Lethal endotoxemia was induced by intraperitoneal administration of LPS at a dose of 20 mg/kg."	1.38	Therapeutic benefits of the group B3 vitamin nicotinamide in mice with lethal endotoxemia and polymicrobial sepsis. ( Ge, P; Li, H; Li, L; Wan, J; Yuan, H; Zhang, L, 2012)

Research

Studies (8)

Authors

Clinical Trials (1)

Trial Overview

Trial Outcomes

Safety and Tolerability of RJX as Assessed by Electrocardiograms (ECGs).

Timeframe	Studies, this research(%)	All Research%
pre-1990	0 (0.00)	18.7374
1990's	0 (0.00)	18.2507
2000's	0 (0.00)	29.6817
2010's	4 (50.00)	24.3611
2020's	4 (50.00)	2.80

Authors	Studies
Uckun, FM	2
Saeed, M	1
Awili, M	1
Ozercan, IH	2
Qazi, S	1
Lee, C	1
Shibli, A	1
Skolnick, AW	1
Prusmack, A	1
Varon, J	1
Barrera, CI	1
Orhan, C	2
Volk, M	2
Sahin, K	2
Brichacek, AL	1
Benkovic, SA	1
Chakraborty, S	1
Nwafor, DC	1
Wang, W	1
Jun, S	1
Dakhlallah, D	1
Geldenhuys, WJ	1
Pinkerton, AB	1
Millán, JL	1
Brown, CM	1
Cheng, L	1
Chen, T	1
Liu, Y	1
Liu, K	1
Liang, H	1
Suchard, MS	1
Savulescu, DM	1
Powell, J	1
Sahin, E	1
Hong, G	1
Zheng, D	1
Zhang, L	2
Ni, R	1
Wang, G	1
Fan, GC	1
Lu, Z	1
Peng, T	1
Yılmaz Karapınar, D	1
Karadaş, N	1
Önder Siviş, Z	1
Balkan, C	1
Kavaklı, K	1
Aydınok, Y	1
Yuan, H	1
Wan, J	1
Li, L	1
Ge, P	1
Li, H	1

Trial	Phase	Enrollment	Study Type	Start Date	Status
A Phase 1, Double-blind, Placebo-controlled, Randomized, Two-Part, Ascending Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Rejuveinix (RJX) in Healthy Participants[NCT03680105]	Phase 1	76 participants (Actual)	Interventional	2018-08-24	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Number of participants with abnormal and clinically significant findings based on ECG. (NCT03680105)
Timeframe: Up to Day 2 for Part 1 and Up to Day 8 for Part 2

Safety and Tolerability of RJX as Assessed by Neurological Examinations.

Intervention	Participants (Count of Participants)
Part 1; Placebo	0
Part 1; Cohort 1; RJX	0
Part 1; Cohort 2; RJX	0
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	0
Part 1; Cohort 5; RJX	0
Part 1; Cohort 6; RJX	0
Part 2; Placebo	0
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	0
Part 2; Cohort 3; RJX	0

Number of participants with clinically significant values and actual changes from baseline of continuous neurological assessments. (NCT03680105)
Timeframe: Up to Day 5 for Part 1 and Up to Day 12 for Part 2

Treatment-related Adverse Events (TEAE) Reporting of RJX

Intervention	Participants (Count of Participants)
Part 1; Placebo	0
Part 1; Cohort 1; RJX	0
Part 1; Cohort 2; RJX	0
Part 1; Cohort 3; RJX	0
Part 1; Cohort 4; RJX	0
Part 1; Cohort 5; RJX	0
Part 1; Cohort 6; RJX	0
Part 2; Placebo	0
Part 2; Cohort 1; RJX	0
Part 2; Cohort 2; RJX	1
Part 2; Cohort 3; RJX	0

Number of participants with indicated AEs receiving RJX as assessed by CTCAE v4 03 (NCT03680105)
Timeframe: Up to Day 5 for Part 1 and Up to Day 12 for Part 2

Article	Year
Nicotinamide pathways as the root cause of sepsis - an evolutionary perspective on macrophage energetic shifts. The FEBS journal, 2022, Volume: 289, Issue:4 Topics: Animals; Biological Evolution; COVID-19; Energy Metabolism; Humans; Macrophages; Niacinamide; Sepsis	2022
Hypertension and Life-Threatening Bleeding in Children with Relapsed Acute Myeloblastic Leukemia Treated with FLT3 Inhibitors. Turkish journal of haematology : official journal of Turkish Society of Haematology, 2015, Volume: 32, Issue:3 Topics: Acidosis; Acute Kidney Injury; Adenine Nucleotides; Antineoplastic Combined Chemotherapy Protocols;	2015

Article	Year
Evaluation of the potential of Rejuveinix plus dexamethasone against sepsis. Future microbiology, 2022, Volume: 17 Topics: Animals; Anti-Inflammatory Agents; Ascorbic Acid; COVID-19 Drug Treatment; Dexamethasone; Disease Mo	2022
Systemic inhibition of tissue-nonspecific alkaline phosphatase alters the brain-immune axis in experimental sepsis. Scientific reports, 2019, 12-11, Volume: 9, Issue:1 Topics: Alkaline Phosphatase; Animals; Astrocytes; Blood-Brain Barrier; Brain; Endothelial Cells; Female; Im	2019
[Progress of nicotinamide in preventing infection and sepsis]. Zhonghua wei zhong bing ji jiu yi xue, 2020, Volume: 32, Issue:7 Topics: Humans; Multiple Organ Failure; Niacinamide; Poly(ADP-ribose) Polymerases; Sepsis; Shock, Septic; Vi	2020
Non-clinical safety profile and pharmacodynamics of two formulations of the anti-sepsis drug candidate Rejuveinix (RJX). Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie, 2021, Volume: 141 Topics: Animals; Anti-Inflammatory Agents; Antioxidants; Ascorbic Acid; Dose-Response Relationship, Drug; Dr	2021
Administration of nicotinamide riboside prevents oxidative stress and organ injury in sepsis. Free radical biology & medicine, 2018, 08-01, Volume: 123 Topics: Animals; Apoptosis; Disease Models, Animal; HMGB1 Protein; Lipopolysaccharides; Macrophages; Male; M	2018
Therapeutic benefits of the group B3 vitamin nicotinamide in mice with lethal endotoxemia and polymicrobial sepsis. Pharmacological research, 2012, Volume: 65, Issue:3 Topics: Animals; Endotoxemia; Lipopolysaccharides; Liver; Male; Mice; Mice, Inbred BALB C; Niacinamide; Seps	2012

niacinamide and Blood Poisoning