Data updated: May 26, 2026
ALIQOPA (copanlisib dihydrochloride)
Trial Activity: Stable 11 active trials
Orphan Drug Priority Review Accelerated Approval Fast Track
Oncology
Approved 2017-09-14
Development Insights
National Cancer Institute (NCI) conducting 9 trials (21%)
199 indications explored (Broad Platform)
→ follicular lymphoma (4 trials)
→ recurrent malignant solid neoplasm (3 trials)
→ refractory malignant solid neoplasm (3 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
8
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2017-09-14
- Patent Cliff
- 2032
- Routes
- INTRAVENOUS
- Dosage Forms
- POWDER
ALIQOPA Approval History
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2017 to 2023
May 2021 SUPPL
Label
What ALIQOPA Treats
1 FDA approvalsOriginally approved for its first indication in 2017 .
- Other (1)
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Clinical Trial Registry
42 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02465060 | NCI-2015-00054 NCI-2015-00054, EAY131 | Ph 2 | active not recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) |
| NCT03502733 | NCI-2017-02249 NCI-2017-02249, NCI CC 18-C-0122 | Ph 1 | active not recruiting | Testing the Combination of Copanlisib, Nivolumab and Ipilimumab in Patients With Advanced Cancer and Lymphoma |
| NCT03474744 | COUP-1 | Ph 2 | active not recruiting | Copanlisib and Rituximab in Marginal Zone Lymphoma Patients |
| NCT06400238 results posted | NCI-2024-01162 NCI-2024-01162, EAY131-Z1H | Ph 2 | active not recruiting | Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H) |
| NCT06360588 results posted | NCI-2024-01141 NCI-2024-01141, EAY131-Z1G | Ph 2 | active not recruiting | Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) |
| NCT02705859 Panther | ICORG 15-02 | Ph 1 | completed | Phase Ib/II Trial of coPANlisib in Combination With Trastuzumab in HER2-positive Breast Cancer. (Panther Study) |
| NCT03586661 | 2017-0404 NCI-2018-01311, 2017-0404 | Ph 1 | active not recruiting | Niraparib and Copanlisib in Treating Patients With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer |
| NCT03789240 results posted | 190030 19-C-0030 | Ph 2 | active not recruiting | Response-Adapted Therapy With Copanlisib and Rituximab in Untreated Follicular Lymphoma |
| NCT03581942 | 18-246 | Ph 1, Ph 2 | completed | Copanlisib With Ibrutinib for Patients With Recurrent/ Refractory Primary Central Nervous System Lymphoma (PCNSL) |
| NCT05082025 results posted | 2020-1241 NCI-2021-09936 | Ph 2 | terminated | 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 |
| NCT04572763 | 20-069 | Ph 1, Ph 2 | active not recruiting | Copanlisib Plus Venetoclax in R/R DLBCL |
| NCT03884998 | 20066 NCI-2018-01880, STUDY00018655 | Ph 1 | active not recruiting | Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma |
| NCT04895579 LCD | MCC-20-LUN-119-PMC | Ph 1 | completed | Lung Cancer With Copanlisib and Durvalumab |
| NCT04108858 results posted | NCI-2019-06461 NCI-2019-06461, MDACC# 2020-0260 | Ph 1, Ph 2 | terminated | 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 |
| NCT03711058 results posted | J1887 IRB00175864, CA209-8LC | Ph 1, Ph 2 | completed | 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 |
| NCT04462471 results posted | 20-053 | Ph 1 | completed | Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers |
| NCT04433182 | FIL_Copa-RB | Ph 2 | terminated | Copanlisib With Rituximab-Bendamustine in Patients With Relapsed-Refractory Diffuse Large B-cell Lymphoma |
| NCT04042051 Panthera | CTRIAL-IE 17-13 | Ph 1 | terminated | Copanlisib in Combination With T-DM1 in Pretreated Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer |
| NCT05687721 | ONCA-016-21F CX002545 | Ph 1, Ph 2 | withdrawn | Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer |
| NCT04685915 | 20-281 | Ph 2 | withdrawn | Copanlisib Plus Ibrutinib or Acalabrutinib in R/R CLL |
| NCT04253262 | BrUOG 360 | Ph 1, Ph 2 | active not recruiting | A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer |
| NCT04750941 results posted | AAAS4953 | Ph 2 | terminated | Study of Copanlisib and Ketogenic Diet |
| NCT06218667 | 23-331 | Ph 1, Ph 2 | withdrawn | A Study of Copanlisib in Combination with Degarelix in People with Prostate Cancer |
| NCT04431635 | UMCC 2019.097 BTCRC-LYM17-145, HUM00166647 | Ph 1 | terminated | 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 |
| NCT04933617 results posted | 10000193 000193-C | Ph 1 | terminated | Copanlisib With Dose-Adjusted EPOCH-R in Relapsed and Refractory Burkitt Lymphoma and Other High-Grade B-cell Lymphomas |
| NCT05387616 Alternative-C | Alternative-C 2018-004038-13 | Ph 2 | active not recruiting | 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 |
| NCT03878524 | STUDY00015588 NCI-2020-02743, STUDY00015588 | Ph 1 | terminated | Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial |
| NCT03735628 | 19769 | Ph 1 | completed | An Study to Evaluate the Safety and Efficacy of Copanlisib in Combination With Nivolumab in Patients With Advanced Solid Tumors |
| NCT03803761 | NCI-2019-00048 NCI-2019-00048, NCI10195 | Ph 1, Ph 2 | withdrawn | A Study of a New Drug Combination, Copanlisib and Fulvestrant, in Advanced Breast Cancer |
| NCT04156828 | RG1005097 NCI-2019-07286, 10332 | Ph 1 | terminated | Copanlisib and Combination Chemotherapy for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma or Relapsed Grade 3b Follicular Lymphoma |
| NCT03877055 results posted | 18-450 | Ph 1, Ph 2 | completed | A Study of Copanlisib and Ibrutinib in Mantle Cell Lymphoma |
| NCT03128619 | 16-001271 NCI-2017-00435 | Ph 1 | terminated | Copanlisib, Letrozole, and Palbociclib in Treating Patients With Hormone Receptor Positive HER2 Negative Stage I-IV Breast Cancer |
| NCT02535247 results posted | HM-075 | Ph 1, Ph 2 | terminated | Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T-cell Non-Hodgkin Lymphoma |
| NCT03052933 | COPGEM | Ph 1, Ph 2 | completed | Copanlisib and Gemcitabine in Relapsed/Refractory PTCL |
| NCT05010096 | 2020-0706 NCI-2021-06215, 2020-0706 | Ph 1 | withdrawn | BAY1895344 and Copanlisib for the Treatment of Molecularly Selected Patients With Advanced Solid Tumors |
| NCT04155840 results posted | RG1005103 NCI-2019-07289, 10325 | Ph 2 | terminated | Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma |
| NCT03886649 | SAKK 66/18 | Ph 1 | terminated | Copanlisib in Combination With Venetoclax in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma. |
| NCT02728258 results posted | NRG-GY008 NCI-2016-00325, NRG-DT1419 | Ph 2 | completed | Copanlisib in Treating Patients With Persistent or Recurrent Endometrial Cancer |
| NCT02631590 results posted | MCC-18435 | Ph 2 | completed | Copanlisib (BAY 80-6946) in Combination With Gemcitabine and Cisplatin in Advanced Cholangiocarcinoma |
| NCT02822482 COPAN-ORL06 | UC-0130/1507 2015-004340-19 | Ph 1, Ph 2 | terminated | 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 |
| NCT04233697 | AAAR5207 | Ph 1 | withdrawn | Copanlisib in Combination With Romidepsin in Patients With Relapsed or Refractory Mature T-cell Lymphoma |
| NCT03377101 | NCI-2017-02320 NCI-2017-02320, 10194 | Ph 2 | withdrawn | Fulvestrant and Palbociclib With or Without Copanlisib in Treating Patients With Hormone Receptor Positive, HER2 Negative, Stage IV Breast Cancer |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ALIQOPA FDA Label Details
View full patent landscape →
3 OB patents · 2 families ·
128 international docs across 49 countries
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Deep insights for ALIQOPA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2032
- • 3 active patents
Trial Analysis
- • 42 total trials
- • Stage: Stable
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment