BMS-707035 Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

A clinical trial sponsored by Bristol-Myers Squibb was designed to evaluate the safety, pharmacodynamics, and pharmacokinetics of BMS-707035 in individuals with HIV infections. This randomized, placebo-controlled Phase 2 study was ultimately withdrawn prior to completion, leaving human evaluation of the compound incomplete. Consequently, no further clinical studies have been initiated, and no completed Phase 2 data exist in published registries.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00397566	Withdrawn	HIV Infections	Bristol-Myers Squibb	2007-02	Phase 2

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

Check the BMS-707035 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

BMS-707035 specifically binds to HIV-1 integrase with an IC50 value of 15 nM, blocking the enzymatic insertion of viral cDNA into the host genome and preventing proviral establishment. This inhibition of viral integration halts productive viral replication within host immune cells, directly underlying its biological potential for the treatment of 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>).