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PI3K inhibitor BKM120
PI3K inhibitor BKM120 is a Small molecule drug developed by Kami Maddocks, MD. It is currently in Phase 1 development. Also known as: BKM120, PI3K_Inhibitor_BKM120, Buparlisib.
BKM120 is a small molecule PI3K inhibitor used in clinical trials for various types of cancer, including non-small cell lung cancer and prostate cancer. It has been studied in combination with other treatments, such as gefitinib and thoracic radiotherapy, in clinical trials.
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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).
| 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 | PI3K inhibitor BKM120 |
|---|---|
| Also known as | BKM120, PI3K_Inhibitor_BKM120, Buparlisib |
| Sponsor | Kami Maddocks, MD |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- The BURAN Study of Buparlisib in Patients With Recurrent or Metastatic HNSCC (PHASE3)
- Double/Triple Combinations of AN2025, AN0025 and Atezolizumab in Advanced Solid Tumors (PHASE1)
- Phase Ib Study of BKM120 With Cisplatin and XRT in High Risk Locally Advanced Squamous Cell Cancer of Head and Neck (PHASE1)
- LGX818 and MEK162 in Combination With a Third Agent (BKM120, LEE011, BGJ398 or INC280) in Advanced BRAF Melanoma (PHASE2)
- Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer (PHASE1)
- GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer (PHASE2)
- Buparlisib in Patients With Relapsed and Refractory Chronic Lymphocytic Leukemia (PHASE2)
- P13Kinase Inhibitor BKM120 in Combination With Panitumumab in Metastatic/Advanced RAS-Wild Type Colorectal 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:
- PI3K inhibitor BKM120 CI brief — competitive landscape report
- PI3K inhibitor BKM120 updates RSS · CI watch RSS
- Kami Maddocks, MD portfolio CI
Frequently asked questions about PI3K inhibitor BKM120
What is PI3K inhibitor BKM120?
Who makes PI3K inhibitor BKM120?
Is PI3K inhibitor BKM120 also known as anything else?
What development phase is PI3K inhibitor BKM120 in?
Related
- Manufacturer: Kami Maddocks, MD — full pipeline
- Also known as: BKM120, PI3K_Inhibitor_BKM120, Buparlisib
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing