Copanlisib Hydrochloride

Phase 2Small molecule

NNational Cancer Institute (NCI)

Copanlisib Hydrochloride is one of 129 small molecule programs targeting Advanced Lymphoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

128

Competitors

Pipeline

Status by Indication[3][1]

Indication

Advanced LymphomaActive, not recruiting

Advanced Malignant Solid NeoplasmActive, not recruiting

Anatomic Stage III Breast Cancer AJCC V8Active, not recruiting

Mantle Cell LymphomaActive, not recruiting

Advanced Solid CancersActive, not recruiting

PIK3CA MutationActive, not recruiting

Advanced LymphomaPhase 2

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 1

Active, not recruiting

Anatomic Stage III Breast Cancer AJCC V8Preclinical

Active, not recruiting

Mantle Cell LymphomaPhase 2

Active, not recruiting

Advanced Solid CancersPhase 2

Active, not recruiting

PIK3CA MutationPhase 2

Active, not recruiting

Competition

Competitive Landscape

54 competitors in Mantle Cell Lymphoma

#DrugCompanyPhaseTrials

Rituxan

Roche

Approved

78 2

Cytosar

Teva

Approved

22 3

Calquence

AstraZeneca

Approved

17 4

Cytoxan

BBaxter Healthcare Corporation

Approved

31 5

Oncovin

Eli Lilly

Approved

11 6

Adriamycin

Pfizer

Approved

9 7

Decadron

AAspen Global Incorporated

Approved

17 8

Thalomid

Bristol-Myers Squibb

Approved

3 9

Rayos

RRoxane Laboratories

Approved

9 10

Vepesid

AAvyxa

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1/2Active, not recruiting

Advanced Solid Cancers

NCT04317105

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Phase 1Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03842228

Q1 2027

Phase 2Active, not recruiting

PIK3CA Mutation

NCT05490771

Q2 2027

PreclinicalActive, not recruiting

Anatomic Stage III Breast Cancer AJCC V8

NCT04345913

Q3 2027

Phase 1Active, not recruiting

Anatomic Stage IV Breast Cancer AJCC V8

NCT03939897

Clinical

Trials by Indication[1]

Mantle Cell Lymphoma1 trial

Copanlisib and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Active, not recruiting·—·Phase 1/2·NCT04939272·8 enrolled

Diffuse Large B-Cell Lymphoma1 trial

Copanlisib Hydrochloride and Nivolumab in Treating Patients With Recurrent or Refractory Diffuse Large B-cell Lymphoma or Primary Mediastinal Large B-cell Lymphoma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03484819·12 enrolled

Advanced Solid Cancers1 trial

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT04317105·54 enrolled

PIK3CA Mutation1 trial

Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05490771·35 enrolled

Breast Cancer1 trial

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Terminated·MMayo Clinic·Phase 1·NCT03432741·17 enrolled

5 more indications

Ovarian Cancer1 trial

Comparing Standard of Care Chemotherapy Treatment to the Combination of Copanlisib and Olaparib for Recurrent Platinum Resistant Ovarian Cancer That Has Progressed Through PARP Inhibitor Therapy

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05295589

Anatomic Stage IV Breast Cancer AJCC v81 trial

A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination With Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03939897·24 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Anatomic Stage III Breast Cancer AJCC v81 trial

A Phase I/II Trial Evaluating the Safety and Efficacy of Eribulin in Combination With Copanlisib in Patients With Metastatic Triple Negative Breast Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Preclinical·NCT04345913·24 enrolled

Advanced Malignant Solid Neoplasm1 trial

A Phase 1b Biomarker-Driven Combination Trial of Copanlisib, Olaparib, and Durvalumab (MEDI4736) in Patients With Advanced Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03842228·39 enrolled

Sources

References

[1]
ClinicalTrials.gov — 10 trial records for Copanlisib Hydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Copanlisib Hydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Copanlisib Hydrochloride. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Cancer Institute (NCI) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: NNational Cancer Institute (NCI)

Copanlisib Hydrochloride

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2027

Trials by Indication[1]

Mantle Cell Lymphoma1 trial

Diffuse Large B-Cell Lymphoma1 trial

Advanced Solid Cancers1 trial

PIK3CA Mutation1 trial

Breast Cancer1 trial

Ovarian Cancer1 trial

Anatomic Stage IV Breast Cancer AJCC v81 trial

Advanced Lymphoma1 trial

Anatomic Stage III Breast Cancer AJCC v81 trial

Advanced Malignant Solid Neoplasm1 trial

References

Drug Info

Quick Facts

Related News