Copanlisib
As of the edition of 20 October 2026, Copanlisib is a small molecule: marketed, first approved in 2017 (US); acts on PIK3CA and PIK3CD; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Aliqopa
- First approved
- 14 September 2017 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Bayer
- Registered trials
- 74, 26 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health
US protection
US protection ends in 2032.
The last listed US drug-substance patent ends in 2032. The application that gives this date is held by Bayer.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product2 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Copanlisib.
See the 2 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 32 | 17 | 4 | 11 |
| Phase 2 | 37 | 11 | 11 | 14 |
| Phase 3 | 3 | 2 | 0 | 1 |
| All trials | 74 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Bayer | Originator and Lead sponsor of trials | 2017 to now |