N-(Hytroxymethy)micotinamide Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Multiple clinical trials evaluate this compound across conditions ranging from oncology—including glioblastoma, bladder cancer, and esophageal squamous cell carcinoma—to chronic obstructive pulmonary disease, post-traumatic stress disorder, and PET imaging validation. Spanning early-stage through Phase II and non-applicable classifications, these studies are sponsored by academic institutions, cooperative research organizations like EORTC, and industry entities such as Servier and Crimson Biopharm Inc. Recruitment statuses across these trials include suspended, not yet recruiting, and withdrawn.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05109754	Suspended	COPD	McGill University Health Centre/Research Institute of the McGill University Health Centre\|University of Calgary	2025-10	Not Applicable
NCT06353282	Not yet recruiting	PTSD Post Traumatic Stress Disorder\|Adolescents\|Psychotherapy	University of California Los Angeles	2025-07-01	Phase 2
NCT05312372	Withdrawn	Esophageal Squamous Cell Carcinoma	Institut de Recherches Internationales Servier\|ADIR a Servier Group company\|Servier	2025-05	Phase 1\|Phase 2
NCT06310369	Not yet recruiting	Bladder Cancer	European Organisation for Research and Treatment of Cancer - EORTC	2025-03-01	Phase 2
NCT03806751	Withdrawn	Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging	University of Alabama at Birmingham	2025-02-01	Early Phase 1
NCT04933422	Not yet recruiting	Glioblastoma	Crimson Biopharm Inc.	2025-01	Phase 1

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

Check the N-(Hytroxymethy)micotinamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

N-(Hydroxymethyl)nicotinamide functions as an antimicrobial agent that binds to essential microbial enzymatic targets, thereby disrupting downstream pyridine nucleotide metabolic pathways and compromising cellular macromolecular synthesis. This inhibition halts pathogenic cell growth and viability, providing a mechanistic rationale for evaluating therapeutic strategies across investigated clinical trial conditions such as oncological malignancies and inflammatory tissue pathologies.

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>).