Isonicotinic acid Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials are evaluating isoniazid-related preventative or therapeutic regimens for conditions including pediatric HIV, latent tuberculosis, and active tuberculosis. Ranging from Phase 1 investigations to non-phase observational and implementation studies, these efforts explore drug kinetics during preventative co-therapy as well as community-based disease control strategies. Academic medical centers, international research consortia, and university sponsors—including Brigham and Women's Hospital, the University of Cape Town, and ANRS Emerging Infectious Diseases—are conducting these studies, with recruitment statuses ranging from active to not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06281834	Not yet recruiting	Pediatric HIV Infection\|Latent Tuberculosis	Brigham and Women''s Hospital\|APIN Public Health Initiatives\|University of Cape Town	2024-05	Phase 1
NCT05655702	Recruiting	Tuberculosis	ANRS Emerging Infectious Diseases\|Haiphong University of Medicine and Pharmacy\|Expertise France\|Université Montpellier\|New York University\|CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES	2023-10-02	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Isonicotinic acid product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a structural isomer and metabolite related to isoniazid metabolism, isonicotinic acid interacts with pyridine-dependent metabolic pathways to interfere with essential bacterial cell wall lipid assembly and metabolic precursor synthesis. This disruption of critical cell membrane components compromises mycobacterial cellular integrity and viability, thereby supporting its mechanistic relevance in clinical evaluations targeting tuberculosis prevention and treatment in populations such as pediatric HIV patients.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).