Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 have evaluated the therapeutic efficacy, safety, and pharmacokinetics of fostemsavir for human immunodeficiency virus type 1 (HIV-1) infections, including multidrug-resistant cases and associated cardiovascular risk factors. Ranging from early bioavailability assessments to pivotal post-marketing evaluations, these studies encompass various recruitment statuses including recruiting, active, completed, and compassionate use programs. Sponsorship is driven by commercial entities such as ViiV Healthcare and GlaxoSmithKline alongside collaborative research networks and foundations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07393659 RECRUITING
HIV Infections
ViiV Healthcare
 2026-07-21 PHASE3
NCT04648280 ACTIVE_NOT_RECRUITING
HIV Infections With Multi Drug Resistant Virus
PENTA Foundation
 2022-06-30 PHASE1; PHASE2
NCT07030920 RECRUITING
Human Immunodeficiency Virus (HIV); Cardiovascular Risk Factor
Centre hospitalier de l'Université de Montréal (CHUM)
 2025-09-30 PHASE2
NCT07053384 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2025-07-10 PHASE1
NCT05220358 ACTIVE_NOT_RECRUITING
HIV-1-infection
Orlando Immunology Center
 2022-06-15 PHASE4
NCT04648280 Recruiting
HIV Infections With Multi Drug Resistant Virus
PENTA Foundation|ViiV Healthcare|PHPT Foundation|Hospital Universitario 12 de Octubre|Cromsource
 2022-06-30 Phase 1|Phase 2
NCT05220358 Recruiting
HIV-1-infection
Orlando Immunology Center|ViiV Healthcare
 2022-05-01 Phase 4
NCT04757974 COMPLETED
HIV Infections
ViiV Healthcare
 2021-03-05 PHASE1
NCT02362503 ACTIVE_NOT_RECRUITING
HIV Infections
ViiV Healthcare
 2015-02-23 PHASE3
NCT02805556 Completed
Infection Human Immunodeficiency Virus
ViiV Healthcare|GlaxoSmithKline
 2016-03-15 Phase 1
NCT02508064 Completed
Infection Human Immunodeficiency Virus
ViiV Healthcare|GlaxoSmithKline
 2015-08-03 Phase 1
NCT02362503 Active not recruiting
HIV Infections
ViiV Healthcare
 2015-02-23 Phase 3

(data from https://clinicaltrials.gov, updated on 2026-08-14)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fostemsavir functions as a phosphonooxymethyl prodrug that converts to its active metabolite BMS-626529, which specifically binds to the HIV-1 envelope glycoprotein 120 (gp120). By binding to gp120, the compound prevents downstream conformational changes necessary for CD4+ T-cell receptor attachment, thereby blocking viral entry and cell infection to suppress viral replication in patients with HIV-1 infections.

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>).

Jump to

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