Vesatolimod (GS-9620) Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 970

Clinical Trials

Vesatolimod (GS-9620) has been evaluated in several clinical trials across Phase I and Phase II, focusing primarily on chronic viral infections including human immunodeficiency virus type 1 (HIV-1) and chronic hepatitis B or C. Key sponsors driving these investigations include Gilead Sciences, Aelix Therapeutics, and the National Institute of Allergy and Infectious Diseases (NIAID). While multiple clinical trials assessing vesatolimod as a monotherapy or combination regimen were successfully completed, other protocols were suspended or terminated during evaluation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06071767	SUSPENDED	HIV-1-infection	National Institute of Allergy and Infectious Diseases (NIAID)	2024-04-01	PHASE1; PHASE2
NCT05281510	COMPLETED	HIV-1-infection	Gilead Sciences	2022-06-09	PHASE2
NCT05458102	TERMINATED	Human Immunodeficiency Virus Type 1 (HIV-1) Infection	Gilead Sciences	2022-08-19	PHASE1
NCT04364035	COMPLETED	HIV/AIDS	Aelix Therapeutics	2020-02-20	PHASE2
NCT03060447	COMPLETED	HIV-1 Infection	Gilead Sciences	2017-05-09	PHASE1
NCT02858401	COMPLETED	HIV-1 Infection	Gilead Sciences	2015-01-29	PHASE1
NCT02579382	COMPLETED	Chronic Hepatitis B	Gilead Sciences	2015-11-10	PHASE2
NCT02166047	COMPLETED	Chronic Hepatitis B	Gilead Sciences	2014-06-30	PHASE2
NCT01590654	COMPLETED	Hepatitis B	Gilead Sciences	2012-04	PHASE1
NCT01590641	COMPLETED	Hepatitis B; HBV	Gilead Sciences	2012-04	PHASE1
NCT01591668	COMPLETED	Hepatitis C	Gilead Sciences	2012-03	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Vesatolimod (GS-9620) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vesatolimod selectively binds to and activates Toll-like receptor 7 (TLR7), triggering downstream intracellular signaling cascades that stimulate the secretion of type I interferons and pro-inflammatory cytokines. This immune activation stimulates innate and adaptive immune effector responses, which aids in targeting viral reservoirs and viral clearance in clinical settings such as HIV-1 infection and chronic hepatitis B.

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>).