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Copanlisib - Bayer HealthCare Pharmaceuticals

Drug Profile

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 hydrochloride

Latest Information Update: 25 Jun 2025

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Marginal zone B-cell lymphoma; Follicular lymphoma; Waldenstrom's macroglobulinaemia; Chronic lymphocytic leukaemia
  • 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

  • 15 Jun 2025 VA Office of Research and Development and Bayer withdraws a phase I/II trial prior to enrolment for Urogenital cancer (Adjunctive therapy, Late-stage disease, Metastatic disease) in USA (IV) (NCT05687721)
  • 10 Dec 2024 Copanlisib is still in the phase III CHRONOS-3 trial for Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, South Korea, Lithuania, Mexico, Malaysia, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine and Vietnam (NCT02367040)
  • 15 Nov 2024 Bayer completes the phase-III CHRONOS-3 trial for Non-Hodgkin's lymphoma (Combination therapy, Second-line therapy or greater) in USA, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Chile, China, Colombia, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, South Korea, Lithuania, Mexico, Malaysia, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Singapore, Slovakia, South Africa, Spain, Taiwan, Thailand, Turkey, Ukraine and Vietnam (NCT02367040),

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