Clinical Trials

Multiple clinical trials evaluate temsavir (BMS-626529) and its prodrug, fostemsavir, primarily targeting human immunodeficiency virus (HIV) infections, including multi-drug resistant cases. Sponsored by key industry and academic entities such as ViiV Healthcare, GlaxoSmithKline, and the PENTA Foundation, these Phase 1 and Phase 1/2 studies assess pharmacokinetic profiles, antiviral efficacy, drug interactions, and relative bioavailability. While several bioavailability and interaction trials have completed evaluation, other studies remain actively recruiting to assess antiviral activity in multi-drug resistant HIV populations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
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
NCT04757974 Completed
HIV Infections
ViiV Healthcare
 2021-03-05 Phase 1
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
NCT02480894 Completed
Infection Human Immunodeficiency Virus
ViiV Healthcare|GlaxoSmithKline
 2015-07-07 Phase 1

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

Check the Temsavir (BMS-626529) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Temsavir (BMS-626529) directly binds to the viral envelope glycoprotein gp120, thereby blocking its conformational transition and preventing interaction with host CD4 cellular receptors. This inhibition of primary viral attachment halts HIV-1 viral entry into host immune cells, providing a targeted therapeutic strategy against both CCR5- and CXCR4-tropic strains in patients with multi-drug resistant HIV 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>).

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