S-Nitrosoglutathione Clinical Trials

Size	Price	Qty
5mg	USD 79
25mg	USD 237

Clinical Trials

Multiple clinical trials are investigating S-nitrosoglutathione for respiratory and pulmonary conditions. These include an actively recruiting Early Phase I trial evaluating S-nitrosoglutathione challenges and GSNO reductase phenotyping in severe asthma patients and healthy volunteers, alongside a Phase I pilot study examining an inhaled formulation for bronchopulmonary dysplasia, which is currently suspended. Sponsored primarily by academic and medical institutions such as Case Western Reserve University and University Hospitals Cleveland Medical Center, these trials also receive federal support from the National Heart, Lung, and Blood Institute.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04619602	Suspended	Bronchopulmonary Dysplasia	University Hospitals Cleveland Medical Center	2024-08-01	Phase 1
NCT03926741	Recruiting	Asthma\|Healthy Volunteers	James Reynolds\|University Hospitals Cleveland Medical Center\|Case Western Reserve University\|National Heart Lung and Blood Institute (NHLBI)	2019-04-30	Early Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

S-nitrosoglutathione acts as an endogenous nitric oxide donor that spontaneously liberates nitric oxide under physiological conditions, thereby selectively inhibiting platelet aggregation and NF-κB activation while dose-dependently modulating T-cell apoptotic pathways. This targeted delivery of nitric oxide reduces local inflammatory signaling and regulates vascular tone, providing the physiological foundation for its therapeutic investigation in pulmonary pathologies including asthma and bronchopulmonary dysplasia.

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>).