Copanlisib

Drug Profile

Copanlisib

Alternative Names: BAY-806946; BAY84-1236

Latest Information Update: 20 Apr 2017

Price : $50

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 1 Phosphatidylinositol 3 kinase inhibitors; Phosphatidylinositol 3 kinase alpha inhibitors; Phosphatidylinositol 3 kinase beta inhibitors; Phosphatidylinositol 3 kinase delta inhibitors; Phosphatidylinositol 3 kinase delta modulators
  • 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

  • Phase III Follicular lymphoma; 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

  • 06 Apr 2017 Bayer completes a phase I pharmacodynamics trial for Non-Hodgkin's lymphoma & Solid tumours (including diabetic patients) in France, United Kingdom and Belgium (NCT02155582)
  • 03 Apr 2017 Bayer Healthcare Pharmaceuticals announces intention to submit NDA to the US FDA for Follicular lymphoma (second-line therapy or greater) under an accelerated approval programme
  • 03 Apr 2017 Copanlisib receives Fast Track designation for Follicular lymphoma [IV,Infusion] (Second-line therapy or greater) in USA
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