# Copanlisib

Source: https://onco.cc/drugs/copanlisib/  
OnCo record `copanlisib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Copanlisib is an intravenous PI3K inhibitor for relapsed follicular lymphoma, approved in 2017 and withdrawn in 2023 when its confirmatory trial failed.

## Summary

Copanlisib is an intravenous pan-class I PI3K inhibitor with predominant PI3K-alpha and PI3K-delta activity, reducing AKT signalling in B-cell lymphoma. Weekly intravenous dosing gives intermittent exposure, and hyperglycaemia and hypertension are on-target alpha effects that appear during infusion. CHRONOS-1 showed a 59% response rate in relapsed indolent lymphoma, supporting accelerated US approval in 2017 for follicular lymphoma after at least two therapies. CHRONOS-3, which added copanlisib to rituximab, was positive for progression-free survival, but CHRONOS-4 failed. After the FDA class review of PI3K inhibitors in 2022, Bayer withdrew the US indication in November 2023. Copanlisib is a case study in how a drug with a real response rate can still be withdrawn when confirmatory trials do not show a clear benefit that outweighs the class toxicity.

## Fields

- Kind: Treatment
- Status: withdrawn
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Aliqopa
- 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.
- Approvals: US 2017: Relapsed follicular lymphoma after ≥2 therapies

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Copanlisib
- Wikipedia: https://en.wikipedia.org/wiki/Copanlisib

## Connected records

- cancers: [Follicular lymphoma](https://onco.cc/cancers/follicular-lymphoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [PI3K delta (PIK3CD)](https://onco.cc/targets/pik3cd/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- terms: [Indication withdrawal](https://onco.cc/terms/approval-withdrawal/), [Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination](https://onco.cc/terms/lymphoma-tx-pjp-and-infection-prophylaxis/)
- trials: [NCI-MATCH (EAY131)](https://onco.cc/trials/nci-match/)

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