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OSI-461
OSI-461 is a Small molecule drug developed by Astellas Pharma Inc. It is currently in Phase 2 development.
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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 | OSI-461 |
|---|---|
| Sponsor | Astellas Pharma Inc |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Dose-Escalating and Safety Study of CP-461 in Patients With Chronic Lymphocytic Leukemia (PHASE1)
- CP-461 for the Treatment of Crohn's Disease (PHASE2)
- A Pilot Study of OSI-461 in Patients With Chronic Lymphocytic Leukemia (CLL) (PHASE2)
- Study of CP-461 in Patients With Advanced Renal Cell Cancer (PHASE2)
- Study Using CP-461 to Treat Advanced Prostate Cancer (PHASE2)
- CP-461 in the Treatment of Patients With Advanced Melanoma (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:
- OSI-461 CI brief — competitive landscape report
- OSI-461 updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI
Frequently asked questions about OSI-461
What is OSI-461?
Who makes OSI-461?
What development phase is OSI-461 in?
Related
- Manufacturer: Astellas Pharma Inc — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing