Bevirimat Clinical Trials

Size	Price	Qty
1mg	USD 147

Clinical Trials

Multiple clinical trials examine Bevirimat across therapeutic areas including HIV-1 infection and multiple sclerosis. A completed Phase 2 study sponsored by Myrexis Inc. evaluated the pharmacokinetic profile of Bevirimat tablet formulations in subjects with HIV-1 infection. Additionally, an active, non-recruiting study sponsored by the State University of New York at Buffalo investigates its application in multiple sclerosis under a non-applicable phase classification.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04953689	Active not recruiting	Multiple Sclerosis	State University of New York at Buffalo	2021-10-19	Not Applicable
NCT01097070	Completed	HIV-1 Infection	Myrexis Inc.	2008-11	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bevirimat selectively binds to the capsid-spacer peptide 1 (CA-SP1) cleavage site within the HIV-1 Gag polyprotein, thereby disrupting the final rate-limiting cleavage executed by the viral protease. This action prevents structural capsid assembly and viral core condensation, resulting in the release of immature, non-infectious virions to suppress viral replication 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>).