Hypoxanthine Clinical Trials

Size	Price	Qty
25mg	USD 79
1g	USD 490

Clinical Trials

Several clinical trials evaluate hypoxanthine or its metabolic pathway across diverse conditions, including gout, liver transplant failure, pancreatic cancer, cerebral ischemia, and age-related physiological changes. These studies encompass Phase 1, Phase 2, combined Phase 1/2, and observational designs sponsored by academic institutions and biopharmaceutical companies. Current recruitment statuses across these clinical records include completed, recruiting, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05361044	Recruiting	Liver Transplant Failure	Hospices Civils de Lyon	2022-08-22	Not Applicable
NCT05256810	Terminated	Gout	Alnylam Pharmaceuticals	2022-02-25	Phase 1\|Phase 2
NCT02498652	Completed	Gout	Ardea Biosciences Inc.	2015-07-28	Phase 2
NCT02187029	Terminated	Gout	Pfizer	2014-07	Phase 1
NCT02170012	Terminated	Healthy Elderly	Pfizer	2014-07	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a naturally occurring purine derivative formed from adenylic acid, hypoxanthine serves as a central metabolic substrate for xanthine oxidase in the purine catabolic pathway, generating downstream purine intermediates and uric acid while reflecting intracellular ATP breakdown. Dysregulation of this enzymatic cascade leads to hyperuricemia and oxidative cell stress, making the modulation and measurement of hypoxanthine clinically relevant for managing metabolic disorders such as gout and evaluating tissue hypoxia in cerebral ischemia or organ transplantation.

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>).