Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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: 15 Dec 2023

Price : $50 *
  • Adis is an information provider. We do not sell or distribute actual drugs.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.
  • A link to download a PDF version of the drug profile will be included in your email receipt.

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

  • 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)
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top