GS-6207 (Lenacapavir) Clinical Trials

Size	Price	Qty
5mg	USD 347
25mg	USD 777

Clinical Trials

Multiple clinical trials evaluate the therapeutic profile of the HIV-1 capsid inhibitor GS-6207 (Lenacapavir) across Phase 1 safety and pharmacokinetic assessments through Phase 2 and Phase 3 efficacy studies. Sponsored predominantly by Gilead Sciences, alongside collaborative efforts with Merck Sharp & Dohme LLC, these trials investigate oral and long-acting regimens combined with background antiretroviral therapies or broadly neutralizing antibodies. Across these investigations, recruitment is currently either completed or active, not recruiting, reflecting advanced clinical evaluation of the drug in managing viral burden.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04811040	COMPLETED	HIV-1 Infection	Gilead Sciences	2021-04-08	PHASE1
NCT04143594	COMPLETED	HIV-1-infection	Gilead Sciences	2019-11-22	PHASE2
NCT05052996	Active not recruiting	HIV-1 Infection	Gilead Sciences\|Merck Sharp & Dohme LLC	2021-10-05	Phase 2
NCT04150068	ACTIVE_NOT_RECRUITING	HIV-1-infection	Gilead Sciences	2019-11-21	PHASE2; PHASE3
NCT03739866	COMPLETED	HIV-1 Infection	Gilead Sciences	2018-11-26	PHASE1
NCT03739866	Completed	HIV-1 Infection	Gilead Sciences	2018-11-26	Phase 1

(data from https://clinicaltrials.gov, updated on 2025-01-27)

Check the GS-6207 (Lenacapavir) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

GS-6207 (Lenacapavir) selectively binds to the HIV-1 capsid protein interface, disrupting viral capsid disassembly and assembly processes required for viral nuclear transport, reverse transcription, and virion maturation. By blocking these essential stages of viral replication, the compound exerts potent antiviral activity, providing the mechanistic basis for its ongoing clinical evaluation in patients with HIV-1 infection.

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>).