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 28 indications[4].[1]

Aliqopa is one of 717 small molecule programs targeting Non-Hodgkins Lymphoma. It is currently in Approved.

Indications

Total Trials

Active Trials

716

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Non-Hodgkins LymphomaActive, not recruiting

Lung CancerActive, not recruiting

T-Cell Non-Hodgkin LymphomaActive, not recruiting

Central Nervous System LymphomaActive, not recruiting

LymphomaActive, not recruiting

Breast CarcinomaApproved

Fallopian Tube CancerActive, not recruiting

Acute Lymphoblastic LeukemiaApproved

Non-Small Cell Lung CancerApproved

Breast CancerActive, not recruiting

Non-Hodgkins LymphomaApproved

Active, not recruiting

Lung CancerPhase 1

Active, not recruiting

T-Cell Non-Hodgkin LymphomaPhase 1/Phase 2

Active, not recruiting

Central Nervous System LymphomaPhase 1/Phase 2

Active, not recruiting

LymphomaPhase 3

Active, not recruiting

Breast CarcinomaApproved

Approved

Fallopian Tube CancerPhase 1

Active, not recruiting

Acute Lymphoblastic LeukemiaApproved

Approved

Non-Small Cell Lung CancerApproved

Approved

Breast CancerPhase 2

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Aliqopa

Bayer

Approved

6 2

Tykerb

GSK

Preclinical

80 3

Avastin

Voltaren

1 5

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 6

Neoadjuvant Therapy

SSun Yat-sen University

Preclinical

3 7

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Preclinical

1 8

Neoadjuvant Treatment

SShanghai Zhongshan Hospital

Preclinical

1 9

Diuretic

RReprieve Cardiovascular, Inc

Preclinical

1 10

Recombinant Human Endostatin

PPeking University Third Hospital

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Phase 1/2Active, not recruiting

DLBCL

NCT04572763

Q4 2026

Phase 1Active, not recruiting

Lymphoma

NCT03884998

Phase 2Active, not recruiting

Treatment

NCT06400238

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Q1 2027

Phase 1/2Active, not recruiting

Prostate Cancer

NCT04253262

Phase 2Active, not recruiting

Follicular Lymphoma

NCT03789240

Clinical

Trials by Indication[1]

Lymphoma11 trials

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

Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma

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

Copanlisib and Rituximab in Marginal Zone Lymphoma Patients

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

Show 8 more trials

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

Withdrawn·—·Phase 1·NCT04233697

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

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

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

Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma

Active, not recruiting·—·Phase 1·NCT03884998·27 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

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, 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

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 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

Diffuse Large B-Cell Lymphoma3 trials

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

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

Completed· Bayer logo

Bayer·Phase 2·NCT02391116·67 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

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

32 more indications

Treatment2 trials

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

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

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

Mantle Cell Lymphoma2 trials

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

Terminated· Bayer logo

Bayer·Phase 2·NCT02455297·4 enrolled

A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma

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

Chemotherapy1 trial

Copanlisib in Combination With Rituximab and CHOP Chemotherapy in Patients With Previously Untreated DLBCL

Unknown status·UUniversity Hospital Muenster·Phase 2·NCT04263584·62 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

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

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

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

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

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

Chronic Lymphocytic Leukemia1 trial

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

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

Pediatric Patients1 trial

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

Terminated· Bayer logo

Bayer·Phase 1/2·NCT03458728·31 enrolled

Metformin1 trial

Effect of Copanlisib on Metformin Pharmacokinetics and Pharmacodynamics

Completed· Bayer logo

Bayer·Phase 1·NCT03655301·13 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

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

CLL1 trial

Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL

Withdrawn·IInhye Ahn·Phase 2·NCT04685915

Trial1 trial

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

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

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

DLBCL1 trial

Copanlisib Plus Venetoclax in R/R DLBCL

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

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

Study of Copanlisib and Ketogenic Diet

Terminated·—·Phase 2·NCT04750941·1 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

Copanlisib Mass Balance Study

Completed· Bayer logo

Bayer·Phase 1·NCT02119221·6 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

Q3 2026

Q4 2026

Q1 2027

Trials by Indication[1]

Lymphoma11 trials

Breast Cancer6 trials

Diffuse Large B-Cell Lymphoma3 trials

Patients With Advanced Solid Tumors2 trials

Prostate Cancer2 trials

Treatment2 trials

Follicular Lymphoma2 trials

Mantle Cell Lymphoma2 trials

Advanced Cancer2 trials

Chemotherapy1 trial

Central Nervous System Lymphoma1 trial

Bladder Cancer1 trial

Endometrial Cancer1 trial

T-cell non-Hodgkin lymphoma1 trial

Cholangiocarcinoma1 trial

Thyroid Cancer1 trial

Phase 21 trial

Head and Neck Squamous Cell Carcinoma1 trial

B-Cell1 trial

Chronic Lymphocytic Leukemia1 trial

Growth1 trial

Refractory1 trial

Renal Impairment1 trial

Pediatric Patients1 trial

Metformin1 trial

B-cell NHL1 trial

Non-Hodgkins Lymphoma1 trial

Cancer1 trial

CLL1 trial

Trial1 trial

Relapsed/Refractory1 trial

Lung Cancer1 trial

DLBCL1 trial

Colorectal Cancer1 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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