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BSI-201
BSI-201 is a DNA-damaging agent Small molecule drug developed by Sanofi. It is currently in Phase 2 development. Also known as: PARP inhibitor.
BSI-201 causes DNA damage through a mechanism distinct from PARP inhibition, though its exact molecular target remains unclear.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Sanofi is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | BSI-201 |
|---|---|
| Also known as | PARP inhibitor |
| Sponsor | Sanofi |
| Drug class | DNA-damaging agent |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
BSI-201 was originally developed as a PARP inhibitor but subsequent studies revealed it does not significantly inhibit PARP enzymes. The drug appears to modify cysteine residues in proteins and may cause DNA damage through alternative pathways, though its precise molecular mechanism remains incompletely understood.
Approved indications
Common side effects
Key clinical trials
- A Trial Evaluating Concurrent Whole Brain Radiotherapy and Iniparib in Multiple Non Operable Brain Metastases (PHASE1)
- Study of the Poly (ADP-ribose) Polymerase-1 (PARP-1) Inhibitor BSI-201 in Patients With Newly Diagnosed Malignant Glioma (PHASE1, PHASE2)
- 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)
- A Study Evaluating BSI-201 in Combination With Chemotherapeutic Regimens in Subjects With Advanced Solid Tumors (PHASE1)
- A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer (PHASE2)
- A Single-Arm Study Evaluating Carboplatin/Gemcitabine in Combination With BSI-201 in Patients With Platinum-Sensitive Recurrent Ovarian Cancer (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)
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:
- BSI-201 CI brief — competitive landscape report
- BSI-201 updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about BSI-201
What is BSI-201?
How does BSI-201 work?
Who makes BSI-201?
Is BSI-201 also known as anything else?
What drug class is BSI-201 in?
What development phase is BSI-201 in?
Related
- Drug class: All DNA-damaging agent drugs
- Manufacturer: Sanofi — full pipeline
- Also known as: PARP inhibitor
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing