Page last updated: 2024-10-20

pyridoxine and Sepsis

pyridoxine has been researched along with Sepsis in 3 studies

4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol: structure in first source
vitamin B6 : Any member of the group of pyridines that exhibit biological activity against vitamin B6 deficiency. Vitamin B6 deficiency is associated with microcytic anemia, electroencephalographic abnormalities, dermatitis with cheilosis (scaling on the lips and cracks at the corners of the mouth) and glossitis (swollen tongue), depression and confusion, and weakened immune function. Vitamin B6 consists of the vitamers pyridoxine, pyridoxal, and pyridoxamine and their respective 5'-phosphate esters (and includes their corresponding ionized and salt forms).

Sepsis: Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.

Research Excerpts

ExcerptRelevanceReference
"Sepsis is a systemic inflammatory response to pathogens and a leading cause of hospital related mortality worldwide."5.43Modulating sphingosine 1-phosphate signaling with DOP or FTY720 alleviates vascular and immune defects in mouse sepsis. ( Gräler, MH; Hemdan, NY; Reimann, CM; Weigel, C, 2016)
" These results demonstrate that RJX-P and RJX-B are bioequivalent relative to their pharmacodynamic effects on tissue SOD and ascorbic acid levels."1.62Non-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 systemic inflammatory response to pathogens and a leading cause of hospital related mortality worldwide."1.43Modulating sphingosine 1-phosphate signaling with DOP or FTY720 alleviates vascular and immune defects in mouse sepsis. ( Gräler, MH; Hemdan, NY; Reimann, CM; Weigel, C, 2016)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's1 (33.33)24.3611
2020's2 (66.67)2.80

Authors

AuthorsStudies
Uckun, FM2
Saeed, M1
Awili, M1
Ozercan, IH2
Qazi, S1
Lee, C1
Shibli, A1
Skolnick, AW1
Prusmack, A1
Varon, J1
Barrera, CI1
Orhan, C2
Volk, M2
Sahin, K2
Powell, J1
Sahin, E1
Hemdan, NY1
Weigel, C1
Reimann, CM1
Gräler, MH1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
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 176 participants (Actual)Interventional2018-08-24Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

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

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

InterventionParticipants (Count of Participants)
Part 1; Placebo0
Part 1; Cohort 1; RJX0
Part 1; Cohort 2; RJX0
Part 1; Cohort 3; RJX0
Part 1; Cohort 4; RJX0
Part 1; Cohort 5; RJX0
Part 1; Cohort 6; RJX0
Part 2; Placebo0
Part 2; Cohort 1; RJX0
Part 2; Cohort 2; RJX0
Part 2; Cohort 3; RJX0

Safety and Tolerability of RJX as Assessed by Neurological Examinations.

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

InterventionParticipants (Count of Participants)
Part 1; Placebo0
Part 1; Cohort 1; RJX0
Part 1; Cohort 2; RJX0
Part 1; Cohort 3; RJX0
Part 1; Cohort 4; RJX0
Part 1; Cohort 5; RJX0
Part 1; Cohort 6; RJX0
Part 2; Placebo0
Part 2; Cohort 1; RJX0
Part 2; Cohort 2; RJX1
Part 2; Cohort 3; RJX0

Treatment-related Adverse Events (TEAE) Reporting of RJX

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

InterventionParticipants (Count of Participants)
Mild TEAE72191553Mild TEAE72191554Mild TEAE72191555Mild TEAE72191556Mild TEAE72191557Mild TEAE72191558Mild TEAE72191559Mild TEAE72191560Mild TEAE72191562Mild TEAE72191563Mild TEAE72191561Moderate TEAE72191553Moderate TEAE72191554Moderate TEAE72191555Moderate TEAE72191556Moderate TEAE72191557Moderate TEAE72191558Moderate TEAE72191559Moderate TEAE72191560Moderate TEAE72191561Moderate TEAE72191562Moderate TEAE72191563Severe TEAE72191553Severe TEAE72191554Severe TEAE72191555Severe TEAE72191556Severe TEAE72191557Severe TEAE72191558Severe TEAE72191559Severe TEAE72191560Severe TEAE72191561Severe TEAE72191562Severe TEAE72191563Related TEAE72191553Related TEAE72191554Related TEAE72191555Related TEAE72191556Related TEAE72191558Related TEAE72191559Related TEAE72191560Related TEAE72191561Related TEAE72191562Related TEAE72191563Related TEAE72191557
Without TEAEWith TEAE
Part 1; Placebo2
Part 1; Cohort 1; RJX1
Part 1; Cohort 2; RJX2
Part 1; Cohort 3; RJX0
Part 1; Cohort 4; RJX2
Part 1; Cohort 5; RJX2
Part 1; Cohort 6; RJX0
Part 2; Placebo1
Part 2; Cohort 1; RJX1
Part 2; Cohort 2; RJX3
Part 2; Cohort 3; RJX2
Part 1; Placebo11
Part 1; Cohort 1; RJX5
Part 1; Cohort 2; RJX4
Part 1; Cohort 3; RJX6
Part 1; Cohort 5; RJX4
Part 1; Cohort 6; RJX9
Part 2; Placebo5
Part 2; Cohort 1; RJX5
Part 2; Cohort 3; RJX4
Part 1; Placebo0
Part 1; Cohort 1; RJX0
Part 1; Cohort 4; RJX1
Part 1; Cohort 5; RJX1
Part 2; Cohort 1; RJX0
Part 2; Cohort 2; RJX0
Part 2; Cohort 3; RJX1
Part 1; Placebo13
Part 1; Cohort 1; RJX6
Part 1; Cohort 2; RJX6
Part 1; Cohort 4; RJX5
Part 1; Cohort 5; RJX5
Part 2; Cohort 1; RJX6
Part 2; Cohort 2; RJX6
Part 2; Cohort 3; RJX5
Part 1; Cohort 2; RJX0
Part 1; Cohort 4; RJX0
Part 1; Cohort 5; RJX0
Part 2; Placebo0
Part 1; Cohort 4; RJX6
Part 1; Cohort 5; RJX6
Part 2; Placebo6
Part 1; Cohort 2; RJX1
Part 2; Cohort 2; RJX2
Part 2; Cohort 3; RJX0
Part 1; Cohort 2; RJX5
Part 1; Cohort 4; RJX4
Part 2; Cohort 2; RJX4
Part 2; Cohort 3; RJX6

Other Studies

3 other studies available for pyridoxine and Sepsis

ArticleYear
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
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
Modulating sphingosine 1-phosphate signaling with DOP or FTY720 alleviates vascular and immune defects in mouse sepsis.
    European journal of immunology, 2016, Volume: 46, Issue:12

    Topics: Animals; Capillary Permeability; Cells, Cultured; Cytokines; Fingolimod Hydrochloride; Immunomodulat

2016