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MLN8237
MLN8237 is a Small molecule drug developed by New Approaches to Neuroblastoma Therapy Consortium. It is currently in Phase 2 development. Also known as: Alisertib.
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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 | MLN8237 |
|---|---|
| Also known as | Alisertib |
| Sponsor | New Approaches to Neuroblastoma Therapy Consortium |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Alisertib, Bortezomib, and Rituximab in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma or B-cell Low Grade Non-Hodgkin Lymphoma (PHASE1)
- Phase 2 Study of Alisertib Therapy for Rhabdoid Tumors (PHASE2)
- A Study of Alisertib and Paclitaxel in Patients With Small Cell Lung Cancer (SCLC) (PHASE2)
- Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer (PHASE2)
- A Study of Alisertib in Patients With Extensive Stage Small Cell Lung Cancer (PHASE2)
- A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer (PHASE2)
- Alisertib and Pembrolizumab for the Treatment of Patients With Rb-deficient Head and Neck Squamous Cell Cancer (PHASE1, PHASE2)
- Alisertib, Abiraterone Acetate and Prednisone in Treating Patients With Hormone-Resistant Prostate Cancer (PHASE1, 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:
- MLN8237 CI brief — competitive landscape report
- MLN8237 updates RSS · CI watch RSS
- New Approaches to Neuroblastoma Therapy Consortium portfolio CI
Frequently asked questions about MLN8237
What is MLN8237?
Who makes MLN8237?
Is MLN8237 also known as anything else?
What development phase is MLN8237 in?
Related
- Manufacturer: New Approaches to Neuroblastoma Therapy Consortium — full pipeline
- Also known as: Alisertib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing