Iniparib (BSI-201) Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

Iniparib (BSI-201) has been evaluated across multiple Phase 1, Phase 2, and Phase 3 clinical trials, focusing predominantly on solid malignancies such as metastatic breast cancer, ovarian cancer, glioblastoma, uterine carcinosarcoma, and advanced non-small cell lung cancer. Sponsored primarily by Sanofi alongside academic entities like the Institut du Cancer de Montpellier - Val d'Aurelle, these studies assessed iniparib as monotherapy or in combination with chemotherapeutics. Currently, these trials have attained completed, terminated, or no longer available recruitment statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01593228	COMPLETED	Solid Tumors	Sanofi	2012-05	PHASE3
NCT00687765	COMPLETED	Glioblastoma	Sanofi	2008-07	PHASE1; PHASE2
NCT01551680	TERMINATED	Brain Metastases	Institut du Cancer de Montpellier - Val d'Aurelle	2012-09	PHASE1
NCT01455532	COMPLETED	Neoplasm Malignant	Sanofi	2011-11	PHASE1
NCT01082549	COMPLETED	Squamous Cell Lung Cancer	Sanofi	2010-03	PHASE3
NCT01213381	COMPLETED	Advance Solid Tumors	Sanofi	2010-09	PHASE1
NCT01033292	COMPLETED	Ovarian Cancer	Sanofi	2009-12	PHASE2
NCT01204125	COMPLETED	Breast Cancer Female	Sanofi	2010-09	PHASE2
NCT01173497	COMPLETED	Estrogen Receptor Negative (ER-Negative) Breast Cancer; Progesterone Receptor Negative (PR-Negative) Breast Cancer; Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer; Brain Metastases	Sanofi	2010-07	PHASE2
NCT00813956	COMPLETED	Triple Negative Breast Cancer	Sanofi	2008-12	PHASE2
NCT01033123	COMPLETED	Ovarian Cancer	Sanofi	2009-12	PHASE2
NCT01086254	COMPLETED	Non-small Cell Lung Cancer Stage IV	Sanofi	2010-05	PHASE2
NCT01045304	COMPLETED	Breast Cancer, Metastatic	Sanofi	2010-02	PHASE2
NCT01161836	COMPLETED	Advanced Solid Tumors	Sanofi	2010-07	PHASE1
NCT00938652	COMPLETED	Breast Cancer	Sanofi	2009-07	PHASE3
NCT00298675	COMPLETED	Tumors	Sanofi	2006-03	PHASE1
NCT01161836	Completed	Advanced Solid Tumors	Sanofi	2010-07	Phase 1
NCT00687687	COMPLETED	Uterine Carcinosarcoma	Sanofi	2008-05	PHASE2
NCT01033292	Completed	Ovarian Cancer	Sanofi	2009-12	Phase 2
NCT01033123	Completed	Ovarian Cancer	Sanofi	2009-12	Phase 2
NCT00540358	COMPLETED	Breast Cancer	Sanofi	2007-10	PHASE2
NCT00422682	COMPLETED	Tumors	Sanofi	2007-01	PHASE1
NCT00677079	COMPLETED	Primary Peritoneal Cancer; Advanced Epithelial Ovarian Cancer	Sanofi	2008-06	PHASE2
NCT00687765	Completed	Glioblastoma	Sanofi	2008-07	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2017-09-19)

Check the Iniparib (BSI-201) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Iniparib covalently binds to poly (ADP-ribose) polymerase-1 (PARP1), inhibiting its enzymatic activity and blocking the repair of single-strand DNA breaks. This accumulation of unrepaired genomic damage leads to double-strand DNA breaks and apoptotic cell death, restricting tumor cell proliferation in clinical indications such as breast cancer, ovarian cancer, and glioblastoma.

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>).