OnCo
drugsProductWithdrawn

Copanlisib

Copanlisib is an intravenous PI3K inhibitor for relapsed follicular lymphoma, approved in 2017 and withdrawn in 2023 when its confirmatory trial failed.

CHRONOS-1: 59% response in relapsed indolent lymphoma (accelerated approval 2017). CHRONOS-3 (with rituximab) was positive for PFS but CHRONOS-4 failed and, after the 2022 FDA class review, Bayer withdrew the US indication in November 2023.

Loading structure…
|
Copanlisib
PubChem
Modality
Intravenous pan-class I PI3K inhibitor (α/δ predominant)
Mechanism
Weekly IV PI3K inhibition with PI3Kα and δ potency, reducing AKT signalling in B-cell lymphoma; hyperglycaemia and hypertension are on-target α effects.
Brand / code
Aliqopa

Regulatory

1top

Approvals

RegionYearIndication
US2017Relapsed follicular lymphoma after ≥2 therapiesWithdrawn 2023

Trials

top
ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
41 studies0 recruiting38 Phase 23 Phase 3
Search “Copanlisib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Copanlisib
intervention: Copanlisib
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Latest papers

top
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Copanlisib" OR ABSTRACT:"Copanlisib" OR TITLE:"Aliqopa" OR ABSTRACT:"Aliqopa") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Copanlisib, not a curated reading list.

Connected

6top