NDAINTRAVENOUSPOWDERPriority Review
Approved
Sep 2017
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
12
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed Yesterday · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALIQOPA (copanlisib dihydrochloride) is an intravenous PI3K inhibitor approved in 2017 for patients with relapsed follicular lymphoma. It is a small-molecule kinase inhibitor that targets phosphatidylinositol 3-kinase (PI3K) to inhibit B-cell proliferation and survival in lymphoid malignancies.
$0.363MPart D
Peak5.6 years to LOEProduct is in peak lifecycle stage with modest Part D penetration (30 claims, $363K spending in 2023), suggesting a niche but stable commercial footprint with limited near-term growth opportunities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (12)
Copanlisib and Avelumab as a Maintenance Therapy for Advanced Bladder Cancer
Started Jun 2025
0Advanced Urothelial Carcinoma
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
Started Sep 2022
7 enrolled
Endometrial CancerOvarian Cancer
Study of Copanlisib and Ketogenic Diet
Started Feb 2022
1 enrolled
Follicular LymphomaEndometrial Cancer
Copanlisib Plus Venetoclax in R/R DLBCL
Started Sep 2021
48 enrolled
Diffuse Large B Cell LymphomaRelapsed Diffuse Large B-Cell LymphomaRefractory Diffuse Large B-Cell Lymphoma
Window Trial to Evaluate Molecular Response to PI3K Inhibition With Copanlisib in r/r Adult B-cell ALL
Started Jun 2021
3 enrolled
Leukemia, Acute Lymphocytic
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.