Cabotegravir
As of the edition of 20 October 2026, Cabotegravir is a small molecule: marketed, first approved in 2020 (CA); US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Cabenuva Kit
- First approved
- 18 March 2020 (CA)
- Approvals on record
- 16 in 6 regions
- Holder of the most recent approval
- GSK; 3 holders in all
- Registered trials
- 86, 3 stopped early
- Disease areas
- Infections; Urinary and reproductive; Immune system; Chemically induced; Digestive system; Mental health
US protection
US protection ends in 2031.
The last listed US drug-substance patent ends in 2031. The application that gives this date is held by GSK.
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 product12 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 12 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 19 | 1 | 12 | 2 |
| Phase 1 | 26 | 22 | 4 | 0 |
| Phase 2 | 14 | 9 | 4 | 1 |
| Phase 3 | 18 | 7 | 11 | 0 |
| Phase 4 | 9 | 5 | 4 | 0 |
| All trials | 86 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 2008 to now |