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pilimumab
pilimumab is a Small molecule drug developed by Memorial Sloan Kettering Cancer Center. It is currently in Phase 2 development.
Ipilimumab is a medication used in combination with other treatments to study various types of cancer, including urothelial carcinoma, bladder cancer, unresectable hepatocellular carcinoma, and advanced stage non-small cell lung cancer. It has been studied in combination with nivolumab, lenvatinib, and other treatments in clinical trials for these conditions.
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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).
| 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 | pilimumab |
|---|---|
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma (PHASE1, PHASE2)
- Evaluate the Mediators of Sensitivity and Resistance to Nivolumab Plus Ipilimumab in Patients With Advanced NSCLCs (PHASE2)
- Checkpoint Inhibition and Chemoradiotherapy as Bladder Sparing Treatment in UC (PHASE2)
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:
- pilimumab CI brief — competitive landscape report
- pilimumab updates RSS · CI watch RSS
- Memorial Sloan Kettering Cancer Center portfolio CI
Frequently asked questions about pilimumab
What is pilimumab?
Who makes pilimumab?
What development phase is pilimumab in?
Related
- Manufacturer: Memorial Sloan Kettering Cancer Center — full pipeline
- Therapeutic area: All drugs in Other
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing