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Copanlisib (BAY 80-6946)
Copanlisib is a pan-class I phosphatidylinositol 3-kinase (PI3K) inhibitor that blocks PI3K signaling to suppress tumor cell proliferation and survival.
Copanlisib is a pan-class I phosphatidylinositol 3-kinase (PI3K) inhibitor that blocks PI3K signaling to suppress tumor cell proliferation and survival. Used for Relapsed or refractory follicular lymphoma, Relapsed or refractory indolent non-Hodgkin lymphoma.
At a glance
| Generic name | Copanlisib (BAY 80-6946) |
|---|---|
| Sponsor | Bayer |
| Drug class | PI3K inhibitor |
| Target | PI3K (phosphatidylinositol 3-kinase), pan-class I |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
Copanlisib inhibits all four isoforms of class I PI3K (α, β, γ, δ), which are frequently dysregulated in hematologic and solid tumors. By blocking PI3K, the drug suppresses the downstream AKT/mTOR signaling pathway, leading to reduced cell proliferation, increased apoptosis, and inhibition of tumor growth. It has shown particular activity in lymphoid malignancies where PI3K signaling is critical for survival.
Approved indications
- Relapsed or refractory follicular lymphoma
- Relapsed or refractory indolent non-Hodgkin lymphoma
Common side effects
- Hyperglycemia
- Diarrhea
- Hypertension
- Nausea
- Fatigue
- Rash
- Pneumonitis
Key clinical trials
- Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (PHASE1, PHASE2)
- Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H) (PHASE2)
- Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) (PHASE2)
- Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma (PHASE1)
- Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (PHASE1, PHASE2)
- Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) (PHASE2)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer (PHASE1)
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:
- Copanlisib (BAY 80-6946) CI brief — competitive landscape report
- Copanlisib (BAY 80-6946) updates RSS · CI watch RSS
- Bayer portfolio CI