Copanlisib - Bayer HealthCare Pharmaceuticals
Alternative Names: 5-Pyrimidinecarboxamide, 2-Amino-N-(2,3-dihydro-7-methoxy-8-(3-(4-morpholinyl)propoxy)imidazo(1,2-C)quinazolin-5-yl)-, Hydrochloride (1:2)Aliqopa; Aliqopa; BAY-80-6946 Dihydrochloride; BAY-806946; BAY-841236; Copanlisib Dihydrochloride; Copanlisib hydrochlorideLatest Information Update: 15 Dec 2023
At a glance
- Originator Bayer Schering Pharma; Memorial Sloan-Kettering Cancer Center; National Cancer Institute (USA)
- Developer All Ireland Cooperative Oncology Research Group; Bayer HealthCare Pharmaceuticals; Bristol-Myers Squibb; Chonnam National University Hospital; H. Lee Moffitt Cancer Center and Research Institute; Memorial Sloan-Kettering Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; UNICANCER; University Hospital Muenster; University of Washington
- Class 3-ring heterocyclic compounds; Amides; Antineoplastics; Imidazoles; Morpholines; Pyrimidines; Quinazolines; Small molecules
- Mechanism of Action Phosphatidylinositol 3 kinase alpha inhibitors; Phosphatidylinositol 3 kinase delta inhibitors
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
Highest Development Phases
- Marketed Follicular lymphoma; Marginal zone B-cell lymphoma
- Registered Non-Hodgkin's lymphoma
- Phase II Cholangiocarcinoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Endometrial cancer; Mantle-cell lymphoma; Solid tumours
- Phase I/II Breast cancer; Colorectal cancer; HER2 positive breast cancer; Peripheral T-cell lymphoma; Squamous cell cancer
- No development reported Lymphoma; Urogenital cancer
Most Recent Events
- 01 Dec 2023 Bayer terminates a phase-III trial in Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in the US, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Singapore, South Korea, Mexico, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine and the UK (IV) due to the reason that trial did not meet its primary endpoints (NCT02626455)
- 13 Nov 2023 Bayer plans to withdraw the NDA of copanlisib for Follicular lymphoma (Second-line therapy or greater) in the US
- 02 Jun 2023 VA Office of Research and Development and Bayer plans a phase I/II trial for Urogenital cancer (Adjunctive therapy, Late-stage disease, Metastatic disease) in USA (IV) in July 2023 (NCT05687721)