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Iniparib (SAR240550/BSI-201)
Iniparib inhibits poly(ADP-ribose) polymerase (PARP), an enzyme involved in DNA repair, thereby sensitizing cancer cells to chemotherapy and radiation.
Iniparib inhibits poly(ADP-ribose) polymerase (PARP), an enzyme involved in DNA repair, thereby sensitizing cancer cells to chemotherapy and radiation. Used for Metastatic triple-negative breast cancer (in combination with chemotherapy), BRCA-mutant cancers.
At a glance
| Generic name | Iniparib (SAR240550/BSI-201) |
|---|---|
| Sponsor | Sanofi |
| Drug class | PARP inhibitor |
| Target | PARP (poly(ADP-ribose) polymerase) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
PARP inhibitors block the repair of DNA damage, particularly single-strand breaks. In cancer cells, especially those with BRCA mutations or homologous recombination deficiency, this leads to accumulation of unrepaired DNA damage and cell death. Iniparib was developed as a PARP inhibitor to enhance the efficacy of chemotherapy agents like gemcitabine and carboplatin.
Approved indications
- Metastatic triple-negative breast cancer (in combination with chemotherapy)
- BRCA-mutant cancers
Common side effects
- Nausea
- Fatigue
- Anemia
- Thrombocytopenia
- Neutropenia
Key clinical trials
- Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial (PHASE3)
- Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients (PHASE2)
- Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC) (PHASE3)
- A Dose Escalation Study of Iniparib as a Single Agent and in Combination in Solid Tumors (PHASE1)
- Study of SAR240550 (BSI-201) in Combination With Gemcitabine/Carboplatin, in Patients With Metastatic Triple Negative Breast Cancer (PHASE2)
- Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (PHASE2)
- SAR240550 in Combination With Gemcitabine/Cisplatin in Non-small Cell Lung Cancer (PHASE2)
- An Open-label Study Investigating the Disposition and QT/QTc Interval Effects of 400 mg [14C]-Iniparib(3.7 MBq, 100 µCi) (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Iniparib (SAR240550/BSI-201) CI brief — competitive landscape report
- Iniparib (SAR240550/BSI-201) updates RSS · CI watch RSS
- Sanofi portfolio CI