Sold as Aliqopa. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Copanlisib Dihydrochloride (sold as Aliqopa), first approved Sep 14, 2017, with 0 new uses approved and 0 published complete response letters.
| Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)Advanced Lymphoma, Advanced Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Aug 8, 2022 |
| Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell LymphomaRecurrent Mantle Cell Lymphoma, Refractory Mantle Cell Lymphoma · City of Hope Medical Center | Phase 1 / Phase 2 | Active, not recruiting | Jun 25, 2021 |
| Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast CancerAnatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 · National Cancer Institute (NCI) | Phase 1 / Phase 2 | Active, not recruiting | Apr 15, 2020 |
| 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 PTENAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 1 / Phase 2 | Active, not recruiting | Mar 23, 2020 |
| Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast CancerAnatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma · National Cancer Institute (NCI) | Phase 1 | Active, not recruiting | May 7, 2019 |
| Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected MutationsAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 1 | Active, not recruiting | Feb 15, 2019 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)Advanced Lymphoma, Advanced Malignant Solid Neoplasm · National Cancer Institute (NCI) | Phase 2 | Active, not recruiting | Jun 8, 2015 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Sep 14, 2017 | AliqopaNDA 209936 · New molecular entity | Bayer Healthcare | 7 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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