Copanlisib hydrochloride is under clinical development by Bayer and currently in Phase II for Mantle Cell Lymphoma. According to GlobalData, Phase II drugs for Mantle Cell Lymphoma have a 34% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Copanlisib hydrochloride’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Copanlisib hydrochloride overview

Copanlisib dihydrochloride (Aliqopa, BAY80-6946) is quinazolinamines derivative acts as an anti-neoplastic agent. It is formulated as lyophilized powder for solution for intravenous route of administration. It is indicated for the treatment of adult patients with relapsed follicular lymphoma (FL) who have received at least two prior systemic therapies.

Copanlisib hydrochloride is under development for the treatment of relapsed, refractory chronic lymphocytic leukemia (CLL), relapsed or refractory adult B-cell acute lymphoblastic leukemia, previously untreated diffuse large b-cell lymphoma (DLBCL), metastatic castration-resistant prostate cancer, elapsed or refractory burkitt lymphoma and other high-grade B-cell Lymphomas, recurrent endometrial cancer, recurrent ovarian cancer, Hodgkin lymphoma, primary peritoneal cancer, fallopian tube cancer, hepatocellular carcinoma, metastatic urothelial carcinoma (transitional cell carcinoma), follicular lymphoma, primary mediastinal large B-cell lymphoma (PMBCL), relapsed indolent or aggressive non-Hodgkin's lymphomas such as indolent B-cell non-Hodgkin lymphoma, marginal zone lymphoma (including nodal, extranodal, splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue lymphoma), lymphoplasmacytic lymphoma/Waldenstrom macroglobulinemia, chronic lymphocytic leukemia (CLL), diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma, anaplastic large cell lymphoma primary systemic type, angioimmunoblastic T cell lymphoma, metastatic breast cancer, relapsed and refractory PTCL, NK/T cell lymphoma, recurrent and metastatic head and neck squamous cell carcinoma, cholangiocarcinoma, gall bladder cancer, multiple myeloma and metastatic colorectal cancer. It was also under development for the treatment of non-small cell lung cancer, triple-negative breast cancer and advanced or refractory solid tumors.

Bayer overview

Bayer is engaged in the discovery, development, manufacturing, and commercialization of products for human health, and agriculture. It provides medicines for cardiovascular diseases, women’s health, cancer, hematology, ophthalmology and other indications. It also strives to develop new molecules and technologies for use in the fields of medicine and modern agriculture. The company’s product portfolio includes prescription products, specialty pharmaceuticals, diagnostic imaging equipment, non-prescription (over the counter or OTC) products, seeds, crop protection solutions and non-agricultural pest control solutions. Bayer markets its healthcare and crop protection products essentially through wholesalers, pharmacies, hospitals and retailers. It operates through a network of subsidiaries in Asia-Pacific, Europe, North America, Latin America, Africa and the Middle East. Bayer is headquartered in Leverkusen, North Rhine-Westphalia, Germany.

For a complete picture of Copanlisib hydrochloride’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.