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Copanlisib - Bayer HealthCare Pharmaceuticals

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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: 20 Jan 2026

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

  • 12 Dec 2025 Bayer terminates phase II trial Solid tumours (Combination therapy, Late-stage disease) in USA (IV) as development of copanlisib was discontinued due to withdrawal of the drug in relapsed follicular lymphoma(NCT05082025)
  • 30 Jun 2025 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins completes a phase I/II trial for microsatellite stable (MSS) Solid tumours and MSS Colon cancer (Combination therapy, Inoperable/unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in the US (IV, Infusion) (NCT03711058)
  • 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)

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