Aliqopa

(Copanlisib)

ApprovedSmall molecule

Copanlisib is used to treat certain types of blood cancers, specifically a form of lymphoma that has stopped responding to other treatments. It works by blocking proteins that help cancer cells grow and divide.[2] Aliqopa is currently approved and in use across 14 indications[4].[1]

Aliqopa is one of 426 small molecule programs targeting Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

425

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

LymphomaActive, not recruiting

TreatmentActive, not recruiting

Acute Lymphoblastic LeukemiaApproved

Non-Small Cell Lung CancerApproved

Squamous Cell CarcinomaApproved

Renal InsufficiencyApproved

Breast CarcinomaApproved

Marginal Zone B-Cell LymphomaApproved

Advanced LymphomaActive, not recruiting

Non-Hodgkins LymphomaCompleted

LymphomaPhase 3

Active, not recruiting

TreatmentPhase 2

Active, not recruiting

Acute Lymphoblastic LeukemiaApproved

Approved

Non-Small Cell Lung CancerApproved

Approved

Squamous Cell CarcinomaApproved

Approved

Renal InsufficiencyApproved

Approved

Breast CarcinomaApproved

Approved

Marginal Zone B-Cell LymphomaApproved

Approved

Advanced LymphomaPhase 2

Active, not recruiting

Non-Hodgkins LymphomaApproved

Completed

Showing 10 of 14 indications

Competition

Competitive Landscape

449 competitors in Non-Small Cell Lung Cancer

#DrugCompanyPhaseTrials

Aliqopa

Bayer

Approved

63 2

Enlonstobart

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Phase 3

2 3

Paclitaxel or Nab-Paclitaxel

AstraZeneca

Phase 3

1 4

Glumetinib

HHaihe Biopharma Co., Ltd.

Phase 3

5 5

Remeron

OOrganon and Co

Preclinical

1 6

Valemetostat Tosylate

Daiichi Sankyo

Preclinical

1 7

Aqupla

Jiangsu Simcere Pharmaceutical Co., Ltd.

Preclinical

—8

Ftorafur

TThe First Affiliated Hospital with Nanjing Medical University

Preclinical

—9

Vibramycin

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Treatment

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

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Chronic Lymphocytic Leukemia

NCT03884998

Phase 2Active, not recruiting

Treatment

NCT06400238

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 2Active, not recruiting

Follicular Lymphoma

NCT03789240

Phase 1/2Active, not recruiting

Prostate Cancer

NCT04253262

Phase 2Active, not recruiting

Treatment

NCT06360588

Clinical

Trials by Indication[1]

Lymphoma10 trials

Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas

Terminated·NNational Cancer Institute (NCI)·Phase 1·NCT04933617·8 enrolled

Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma

Withdrawn·—·Phase 1·NCT04233697

A Study to Learn More About Copanlisib Treatment Patterns in People With Indolent Non-Hodgkin Lymphoma, a Type of Cancer That Grows and Spread Slowly and Develops in the Lymphatic System (a Part of Immune System) in Taiwan Under Real-word Conditions

Completed· Bayer logo

Bayer··NCT05217914·6 enrolled

Show 7 more trials

Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)

Completed· Bayer logo

Bayer·Phase 3·NCT02367040·458 enrolled

Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)

Terminated· Bayer logo

Bayer·Phase 3·NCT02626455·551 enrolled

Open-label, Uncontrolled Phase II Trial of Intravenous PI3K Inhibitor BAY80-6946 in Patients With Relapsed, Indolent or Aggressive Non-Hodgkin's Lymphomas

Completed· Bayer logo

Bayer·Phase 2·NCT01660451·227 enrolled

Dose De-escalation Study of the PI3k Alpha/Delta Inhibitor, Copanlisib Given in Combination With the Immunotherapeutic Agents, Nivolumab and Rituximab in Patients With Relapsed/Refractory Indolent Lymphoma

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 1·NCT04431635·6 enrolled

Copanlisib and Rituximab in Marginal Zone Lymphoma Patients

Active, not recruiting·CChristian Buske·Phase 2·NCT03474744·36 enrolled

Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma.

Terminated·SSwiss Cancer Institute·Phase 1·NCT03886649·7 enrolled

Phase Ib Study of Copanlisib in Combination With Nivolumab or With Nivolumab and Ipilimumab

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT03502733·64 enrolled

Breast Cancer6 trials

A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 1/2·NCT03803761

Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer

Terminated·NNational Cancer Institute (NCI)·Phase 1/2·NCT04108858·2 enrolled

Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03377101

Show 3 more trials

Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer

Terminated·CCancer Trials Ireland·Phase 1·NCT04042051·2 enrolled

Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study)

Completed·CCancer Trials Ireland·Phase 1·NCT02705859·26 enrolled

Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer

Terminated·JJonsson Comprehensive Cancer Center·Phase 1·NCT03128619·10 enrolled

Diffuse Large B-Cell Lymphoma4 trials

Phase II Copanlisib in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Completed· Bayer logo

Bayer·Phase 2·NCT02391116·67 enrolled

Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma

Terminated·UUniversity of Washington·Phase 1·NCT04156828·12 enrolled

Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma

Terminated·FFondazione Italiana Linfomi - ETS·Phase 2·NCT04433182·37 enrolled

Show 1 more trial

A Prospective Multicenter Phase 2 Study of Copanlisib in Combination With Rituximab and CHOP Chemotherapy (COPA-R-CHOP) in Patients With Previously Untreated Diffuse Large B-cell Lymphoma (DLBCL)

Completed·UUniversity Hospital Muenster·Phase 2·NCT04263584·62 enrolled

Mantle Cell Lymphoma2 trials

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03877055·8 enrolled

Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)

Terminated· Bayer logo

Bayer·Phase 2·NCT02455297·4 enrolled

Treatment2 trials

Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06400238·35 enrolled

Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06360588·22 enrolled

31 more indications

Chronic Lymphocytic Leukemia2 trials

Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Terminated·UUniversity of Washington·Phase 2·NCT04155840·1 enrolled

A Phase I Study of PI3Kα,δ Inhibitor Copanlisib in Combination With PD-1 Antagonist Nivolumab in Patients With Transformed Chronic Lymphocytic Leukemia (Richter's Transformation) or Non-Hodgkin Lymphoma

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT03884998·27 enrolled

Advanced Cancer2 trials

Phase I Study of PI3(Phosphoinositol 3)-Kinase Inhibitor BAY80-6946 With Paclitaxel in Patients With Advanced Cancer

Completed· Bayer logo

Bayer·Phase 1·NCT01411410·55 enrolled

BAY80-6946 Open Label, Phase I Study in Patients With Advanced Cancer

Completed· Bayer logo

Bayer·Phase 1·NCT00962611·57 enrolled

Patients With Advanced Solid Tumors2 trials

BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT05010096

An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors

Completed· Bayer logo

Bayer·Phase 1·NCT03735628·16 enrolled

Follicular Lymphoma2 trials

Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03789240·33 enrolled

A Prospective Multicenter Phase 2 Study of the Chemotherapy-Free Combination of the Intravenous Phosphatidylinositol-3-Kinase (PI3K) Inhibitor Copanlisib in Combination With Obinutuzumab in Patients With Previously Untreated Follicular Lymphoma (FL) and a High Tumor Burden

Active, not recruiting·LLudwig-Maximilians - University of Munich·Phase 2·NCT05387616·98 enrolled

Prostate Cancer2 trials

A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer

Active, not recruiting·—·Phase 1/2·NCT04253262·13 enrolled

A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer

Withdrawn·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT06218667

CLL1 trial

Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

Withdrawn·IInhye Ahn·Phase 2·NCT04685915

Relapsed/Refractory1 trial

Copanlisib and Gemcitabine in Relapsed/Refractory PTCL

Completed·—·Phase 1/2·NCT03052933·28 enrolled

Lung Cancer1 trial

Lung Cancer With Copanlisib and Durvalumab

Completed·ZZhonglin Hao·Phase 1·NCT04895579·11 enrolled

Trial1 trial

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

T-cell non-Hodgkin lymphoma1 trial

Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma

Terminated·FFox Chase Cancer Center·Phase 1/2·NCT02535247·17 enrolled

Phase 21 trial

Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT05082025·7 enrolled

Colorectal Cancer1 trial

Study of PI3Kinase Inhibition (Copanlisib) and Anti-PD-1 Antibody Nivolumab in Relapsed/Refractory Solid Tumors With Expansions in Mismatch-repair Proficient (MSS) Colorectal Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT03711058·48 enrolled

Pediatric Patients1 trial

Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients

Terminated· Bayer logo

Bayer·Phase 1/2·NCT03458728·31 enrolled

B-cell NHL1 trial

Japanese Phase Ib/II Copanlisib in Relapsed, Indolent B-cell NHL

Completed· Bayer logo

Bayer·Phase 1/2·NCT02342665·25 enrolled

Non-Hodgkins Lymphoma1 trial

COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients

Completed· Bayer logo

Bayer·Phase 1·NCT02253420·51 enrolled

Growth1 trial

Phase 1 Study of the Combination of Rogaratinib With Copanlisib in Patients With Fibroblast Growth Factor Receptor (FGFR)-Positive, Locally Advanced or Metastatic Solid Tumors

Completed· Bayer logo

Bayer·Phase 1·NCT03517956·16 enrolled

Refractory1 trial

Phase III Copanlisib in Rituximab-refractory iNHL

Completed· Bayer logo

Bayer·Phase 3·NCT02369016·25 enrolled

Renal Impairment1 trial

Study of Copanlisib in Hepatic or Renal Impairment

Completed· Bayer logo

Bayer·Phase 1·NCT03172884·30 enrolled

Metformin1 trial

Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

Completed· Bayer logo

Bayer·Phase 1·NCT03655301·13 enrolled

Cholangiocarcinoma1 trial

Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 2·NCT02631590·24 enrolled

Thyroid Cancer1 trial

Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT04462471·8 enrolled

Cancer1 trial

Expanded Access to Provide Copanlisib for Patients With Cancer Who Are Experiencing a Positive Response, as Determined by Their Doctors

No longer available· Bayer logo

Bayer··NCT06238583

Head and Neck Squamous Cell Carcinoma1 trial

Copanlisib in Association With Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinomas Harboring a PI3KCA Mutation/Amplification and/or a PTEN Loss

Terminated·UUNICANCER·Phase 1/2·NCT02822482·11 enrolled

Central Nervous System Lymphoma1 trial

Copanlisib With Ibrutinib for Patients With Recurrent/ Refractory Primary Central Nervous System Lymphoma (PCNSL)

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1/2·NCT03581942·18 enrolled

Bladder Cancer1 trial

Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer

Withdrawn·VVA Office of Research and Development·Phase 1/2·NCT05687721

Endometrial Cancer1 trial

Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer

Completed·NNRG Oncology·Phase 2·NCT02728258·11 enrolled

DLBCL1 trial

Copanlisib Plus Venetoclax in R/R DLBCL

Active, not recruiting·—·Phase 1/2·NCT04572763·48 enrolled

B-Cell1 trial

Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL

Terminated·—·Phase 1·NCT04803123·3 enrolled

Advanced Lymphoma1 trial

Molecular Analysis for Therapy Choice (MATCH)

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

Deleterious BRCA1 Gene Mutation1 trial

A Phase Ib Study of the Oral PARP Inhibitor Niraparib With the Intravenous PI3K Inhibitor Copanlisib for Recurrent Endometrial and Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03586661·31 enrolled

Unspecified4 trials

Copanlisib Mass Balance Study

Completed· Bayer logo

Bayer·Phase 1·NCT02119221·6 enrolled

Copanlisib Chinese PK Study

Completed· Bayer logo

Bayer·Phase 1·NCT03498430·13 enrolled

Copanlisib Pharmacodynamic Study

Completed· Bayer logo

Bayer·Phase 1·NCT02155582·63 enrolled

Show 1 more trial

Study of Copanlisib and Ketogenic Diet

Terminated·—·Phase 2·NCT04750941·1 enrolled

Regulatory

FDA Approval Timeline[5]

Sep 14, 2017

ALIQOPA

NDA NDA209936

Sources

References

[1]
ClinicalTrials.gov — 63 trial records for Copanlisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Aliqopa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Copanlisib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Copanlisib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA209936). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Aliqopa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase P110-Alpha Subunit Inhibitor; PI3-Kinase P110-Delta Subunit Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

Oct 22, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE46856Oct 22, 2029

9636344Mar 29, 2032

10383876Mar 29, 2032

Aliqopa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Lymphoma10 trials

Breast Cancer6 trials

Diffuse Large B-Cell Lymphoma4 trials

Mantle Cell Lymphoma2 trials

Treatment2 trials

Chronic Lymphocytic Leukemia2 trials

Advanced Cancer2 trials

Patients With Advanced Solid Tumors2 trials

Follicular Lymphoma2 trials

Prostate Cancer2 trials

CLL1 trial

Relapsed/Refractory1 trial

Lung Cancer1 trial

Trial1 trial

T-cell non-Hodgkin lymphoma1 trial

Phase 21 trial

Colorectal Cancer1 trial

Pediatric Patients1 trial

B-cell NHL1 trial

Non-Hodgkins Lymphoma1 trial

Growth1 trial

Refractory1 trial

Renal Impairment1 trial

Metformin1 trial

Cholangiocarcinoma1 trial

Thyroid Cancer1 trial

Cancer1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Central Nervous System Lymphoma1 trial

Bladder Cancer1 trial

Endometrial Cancer1 trial

DLBCL1 trial

B-Cell1 trial

Advanced Lymphoma1 trial

Deleterious BRCA1 Gene Mutation1 trial

Unspecified4 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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