Last reviewed · How we verify
BGB-15025
BGB-15025 is a Menin inhibitor Small molecule drug developed by BeiGene. It is currently in Phase 3 development for Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement, Acute lymphoblastic leukemia (ALL) with MLL rearrangement.
BGB-15025 is a selective inhibitor of menin that disrupts the interaction between menin and mixed-lineage leukemia (MLL) proteins, restoring normal gene expression in acute leukemias.
BGB-15025 is a study of Tislelizumab, Pamiparib, and Temozolomide in participants with Advanced Malignancies, including Non-small Cell Lung Cancer and Advanced Solid Tumor. The study is conducted by BeOne Medicines, with the identifier NCT04164199.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Oncology Phase 3 boost
+3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | BGB-15025 |
|---|---|
| Sponsor | BeiGene |
| Drug class | Menin inhibitor |
| Target | Menin (MEN1 protein) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Menin is a scaffolding protein that interacts with MLL complexes to drive oncogenic gene expression in leukemias with MLL rearrangements or NPM1 mutations. By blocking this menin-MLL interaction, BGB-15025 suppresses the transcription of leukemogenic genes including HOXA9 and MEIS1, leading to differentiation and apoptosis of leukemic cells. This mechanism is particularly effective in acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) with these genetic alterations.
Approved indications
- Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement
- Acute lymphoblastic leukemia (ALL) with MLL rearrangement
Common side effects
- Differentiation syndrome
- Cytopenias (neutropenia, thrombocytopenia, anemia)
- Infection
- Nausea and vomiting
- Diarrhea
Key clinical trials
- Study of Tislelizumab, Pamiparib, and Other Investigational Agents in Participants With Advanced Malignancies (PHASE3)
- A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer (PHASE2)
- BGB-15025 Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Participants With Advanced Solid Tumors (PHASE1)
- A Study of Gimistotug (BGB-A445) in Combination With Other Investigational Agents in Participants With Non-Small Cell Lung Cancer (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:
- BGB-15025 CI brief — competitive landscape report
- BGB-15025 updates RSS · CI watch RSS
- BeiGene portfolio CI
Frequently asked questions about BGB-15025
What is BGB-15025?
How does BGB-15025 work?
What is BGB-15025 used for?
Who makes BGB-15025?
What drug class is BGB-15025 in?
What development phase is BGB-15025 in?
What are the side effects of BGB-15025?
What does BGB-15025 target?
Related
- Drug class: All Menin inhibitor drugs
- Target: All drugs targeting Menin (MEN1 protein)
- Manufacturer: BeiGene — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Acute myeloid leukemia (AML) with NPM1 mutation or MLL rearrangement
- Indication: Drugs for Acute lymphoblastic leukemia (ALL) with MLL rearrangement
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing