Copanlisib - Bayer HealthCare Pharmaceuticals

Drug Profile

Copanlisib - Bayer HealthCare Pharmaceuticals

Alternative Names: Aliqopa; BAY-806946; BAY84-1236; Copanlisib hydrochloride

Latest Information Update: 15 Sep 2017

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At a glance

  • Originator Bayer Schering Pharma
  • Developer All Ireland Cooperative Oncology Research Group; Bayer HealthCare Pharmaceuticals; H. Lee Moffitt Cancer Center and Research Institute; National Cancer Institute (USA)
  • 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 - Follicular lymphoma; MALT lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Registered Follicular lymphoma
  • Phase III MALT lymphoma; Non-Hodgkin's lymphoma
  • Phase II Cholangiocarcinoma; Diffuse large B cell lymphoma; Endometrial cancer; Mantle-cell lymphoma
  • Phase I/II Breast cancer
  • Phase I Solid tumours

Most Recent Events

  • 14 Sep 2017 Registered for Follicular lymphoma (Second-line therapy or greater) in USA (IV) - First global approval
  • 02 Aug 2017 Phase-I/II clinical trials in Breast cancer (Combination therapy, First-line therapy) in USA (IV) (NCT03128619)
  • 14 Jun 2017 Bayer initiates enrolment in a phase I pharmacokinetics trial (In volunteers) in Germany (NCT03172884)
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