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MSC1936369B
MSC1936369B is a Small molecule drug developed by Sanofi. It is currently in Phase 1 development. Also known as: Pimasertib.
MSC1936369B, also known as Pimasertib, is a small molecule used in clinical trials for various cancer types, including N-Ras mutated locally advanced or metastatic malignant cutaneous melanoma and metastatic colorectal cancer. It has been studied in a Phase II trial as a potential treatment compared to Dacarbazine in N-Ras mutated cutaneous melanoma.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% 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 | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | MSC1936369B |
|---|---|
| Also known as | Pimasertib |
| Sponsor | Sanofi |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Bintrafusp Alfa and Pimasertib for the Treatment of Patients With Brain Metastases (PHASE1, PHASE2)
- Trial of MSC1936369B in Subjects With Solid Tumors (PHASE1)
- Combination Trial of Pimasertib (MSC1936369B) With Temsirolimus (PHASE1)
- Phase II Trial of Pimasertib Versus Dacarbazine in N-Ras Mutated Cutaneous Melanoma (PHASE2)
- Trial of Pimasertib in Hematological Malignancies (PHASE2)
- Relative Bioavailability of Pimasertib in Cancer Patients (PHASE1)
- Trial of Gemcitabine With or Without MSC1936369B in Pancreatic Cancer (PHASE1, PHASE2)
- Trial of MEK Inhibitor and PI3K/mTOR Inhibitor in Subjects With Locally Advanced or Metastatic Solid Tumors (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:
- MSC1936369B CI brief — competitive landscape report
- MSC1936369B updates RSS · CI watch RSS
- Sanofi portfolio CI
Frequently asked questions about MSC1936369B
What is MSC1936369B?
Who makes MSC1936369B?
Is MSC1936369B also known as anything else?
What development phase is MSC1936369B in?
Related
- Manufacturer: Sanofi — full pipeline
- Also known as: Pimasertib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing