2,6-Dihydroxypurine Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

Several clinical trials evaluate pathways and interventions associated with 2,6-dihydroxypurine across Phase 1, Phase 2, and non-applicable observational or supportive study designs. Sponsored by academic medical centers, government institutions such as the VA Office of Research and Development, and industry partners including Alnylam Pharmaceuticals, these studies investigate indications such as heart failure with preserved ejection fraction, resistant hypertension, liver transplant graft failure, intensive trauma rehabilitation, gout, and non-small-cell lung carcinoma. Their recruitment statuses currently range from actively recruiting and completed to terminated protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05888233	Recruiting	Heart Failure Preserved Ejection Fraction\|Resistant Hypertension	VA Office of Research and Development	2023-08-02	Phase 2
NCT05361044	Recruiting	Liver Transplant Failure	Hospices Civils de Lyon	2022-08-22	Not Applicable
NCT05351333	Recruiting	Spinal Cord Injuries\|Polytrauma\|Burns	Spaulding Rehabilitation Hospital\|National Institute on Drug Abuse (NIDA)	2022-08-03	Not Applicable
NCT05256810	Terminated	Gout	Alnylam Pharmaceuticals	2022-02-25	Phase 1\|Phase 2
NCT04676009	Completed	Carcinoma Non-Small-Cell Lung	Centre Leon Berard\|Claude Bernard University\|Lyon Cancer Research Centre\|Hospices Civils de Lyon\|Inter-university Laboratory of Human Movement Biology	2021-01-21	Not Applicable

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

Check the 2,6-Dihydroxypurine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As an endogenous purine metabolite, 2,6-dihydroxypurine binds to xanthine oxidase within the purine catabolic pathway, regulating the enzymatic conversion of hypoxanthine to uric acid and modulating cellular reactive oxygen species generation. This metabolic regulation is clinically relevant to controlling hyperuricemic states such as gout and mitigating oxidative stress associated with cardiovascular and tissue-injury conditions evaluated in clinical trials.

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>).