Duvelisib
As of the edition of 20 October 2026, Duvelisib is a small molecule: marketed, first approved in 2018 (US); acts on PIK3CD and PIK3CG; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Copiktra
- First approved
- 24 September 2018 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Secura Bio
- Withdrawn from market
- 16 February 2026 (in some regions)
- Registered trials
- 55, 16 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Infections; Inherited and neonatal; Nervous system
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 Secura Bio.
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 product4 listings count towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
2 company-target rows on route B and 6 company-target rows on route A because of this drug.
Companies on route B for this drug
In the product2 company-target rows are on route B because of Duvelisib.
Companies on route A for this drug
In the product6 company-target rows are on route A because of Duvelisib.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 1 | 1 |
| Phase 1 | 22 | 12 | 5 | 5 |
| Phase 2 | 26 | 8 | 8 | 8 |
| Phase 3 | 5 | 2 | 1 | 2 |
| All trials | 55 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Secura Bio | Acquired holder | 2021 to now |
| Verastem | Originator | 2018 to 2021 |