Clinical Trials

Several clinical trials evaluate guanosine-related signaling and purine nucleoside pathways across Phase 1, Phase 2, and Phase 2/3 protocols. Sponsored by both academic institutions and pharmaceutical companies, these studies address diverse indications including metabolic syndrome, obstructive sleep apnea, Lewy body disease, Parkinson disease, cardiovascular diseases, and hepatocellular carcinoma. Recruitment statuses across these trials range from actively recruiting and completed to not yet recruiting or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06320951 NOT_YET_RECRUITING
Cardiovascular Diseases; Insulin Sensitivity/Resistance; Metabolic Disease; Metabolism; Energy Expenditure; Obesity
University of Alabama at Birmingham
 2026-12-01 PHASE2
NCT05711719 Recruiting
Metabolic Syndrome|Coronary Microvascular Dysfunction
Johns Hopkins University|Merck Sharp & Dohme LLC
 2023-06-16 Phase 2
NCT03235167 UNKNOWN
Hepatocellular Carcinoma
Dalian University
 2017-10 PHASE1
NCT05009901 Recruiting
Obstructive Sleep Apnea of Adult
University of British Columbia
 2022-06-01 Phase 2|Phase 3
NCT04764669 Completed
Lewy Body Disease|Parkinson Disease
Eisai Inc.
 2021-02-25 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-01-23)

Check the Guanosine 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 nucleoside, guanosine binds purinergic receptors and enters nucleoside salvage pathways, regulating downstream cyclic guanosine monophosphate cascades and cellular metabolic responses. This attenuation of cellular stress and inflammatory signaling supports tissue protection, providing clinical relevance across trial conditions including metabolic syndrome, cardiovascular dysfunction, neurodegenerative diseases, and hepatocellular carcinoma.

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>).

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Note: Technical data last updated: Sep 1, 2026.