6-Biopterin Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Several completed clinical trials evaluate conditions associated with vascular and metabolic pathology, specifically focusing on oxidative stress, acute cholecystitis, endothelial dysfunction, and myocardial injury. Spanning early-stage Phase II, non-applicable, and unassigned phase designs, these investigations were sponsored primarily by academic medical centers and hospital networks, including Shahid Beheshti University of Medical Sciences, Zealand University Hospital, and Rigshospitalet Denmark. Together, these protocols evaluated markers of oxidative tissue damage, endothelial integrity, and perioperative vascular complications.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04375137	Completed	Oxidative Stress	Shahid Beheshti University of Medical Sciences	2020-04-20	--
NCT04156711	Completed	Acute Cholecystitis\|Endothelial Dysfunction	Zealand University Hospital	2019-09-04	Not Applicable
NCT02690233	Completed	Myocardial Injury	Zealand University Hospital	2016-02	--
NCT02256254	Completed	Oxidative Stress	Rigshospitalet Denmark\|Klinisk Biokemisk Afdeling\|Klinisk farmakologisk Afdeling\|Sektion for Biomedicin Institut for Veterinær Patobiologi	2014-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

6-Biopterin serves as an essential pteridine cofactor component in enzymatic redox cycles, regulating nitric oxide synthase activity to promote functional nitric oxide production while suppressing superoxide radical formation. By preserving intracellular redox homeostasis and supporting vascular endothelial cell viability, this biopterin-dependent pathway mitigates pathological processes linked to endothelial dysfunction, oxidative stress, and myocardial injury.

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>).