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Copanlisib

Alternative Names: copanlisib, bay 80-6946, bay80-6946, bay-806946, bay806946, bay 806946, aliqopa
Latest Update: 2024-12-18
Latest Update Note: Clinical Trial Update

Product Description

Copanlisib (BAY 80-6946) is a pan-specific PI3K small molecule inhibitor for four key isoforms with increased activity against PI3Kalpha and PI3Kdelta, both important in B-cell malignancies.  (Sourced from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6097514/)

Mechanisms of Action: PI3K Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Intravenous

FDA Designation: None *

Approval Status: Approved

Approved Countries: Israel | Taiwan | United States

Approved Indications: Follicular Lymphoma | Lymphoma

Known Adverse Events: Hypertension | Leukopenia | Thrombocytopenia | Neutropenia | Respiratory Tract Infections | Hyperglycemia | Diarrhea

Company: Elanco Animal Health
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Copanlisib

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Poland, Portugal, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 21

Highest Development Phases

Phase 3: Lymphoma, Non-Hodgkin

Phase 2: B-Cell Marginal Zone Lymphoma|Bladder Cancer|Breast Cancer|Colorectal Cancer|Diffuse Large B-Cell Lymphoma|Endometrial Cancer|Follicular Lymphoma|Lymphoma|Mantle-Cell Lymphoma|Marginal Zone Lymphoma|Neuroblastoma|Osteosarcoma|Ovarian Cancer|Prostate Cancer|Rhabdomyosarcoma|Sarcoma, Ewing|Transitional Cell Carcinoma

Phase 1: Head and Neck Cancer|Hepatocellular Carcinoma|Non-Small-Cell Lung Cancer|Squamous Cell Carcinoma

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
COUP-1

P2

Active, not recruiting

Marginal Zone Lymphoma

2028-08-06

ONCA-016-21F

P2

Not yet recruiting

Transitional Cell Carcinoma|Bladder Cancer

2028-06-30

Safety, tolerability, efficacy and pharmacokinetics of copanlisib in pediatric patients

P2

Active, not recruiting

Neuroblastoma|Rhabdomyosarcoma|Lymphoma|Sarcoma, Ewing|Osteosarcoma

2027-11-27

BrUOG 360

P2

Active, not recruiting

Prostate Cancer

2027-01-01

Recent News Events

Date

Type

Title

11/13/2023

News Article

 Bayer Provides Update on Aliqopa® (copanlisib)

10/09/2023

News Article

 Phosphoinositide 3-Kinase Inhibitor Market 2023 Witness Widespread Expansion of Industry Growth with leading

05/25/2023

News Article

 Bayer Presents New Data Across Oncology Portfolio at the 2023 ASCO Annual Meeting

04/04/2023

News Article

 Phosphoinositide 3-Kinase (PI3K) Inhibitors Market size to grow by USD 71.29 million from 2021 to 2026, Driven by the recent approvals for therapies - Technavio

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