Cosibelimab
As of the edition of 20 October 2026, Cosibelimab is an antibody: marketed, first approved in 2024 (US); acts on CD274; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Antibody
- Brand name
- Unloxcyt
- First approved
- 13 December 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- SUN Pharmaceutical Industries
- Registered trials
- 6, 2 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Lungs and airways; Skin and connective tissue; Heart and blood vessels
US protection
US protection ends in 2036.
US protection ends in 2036, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by SUN Pharmaceutical Industries. The date is computed, not published.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Cosibelimab.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CD274 | Programmed cell death 1 ligand 1 | Q9NZQ7 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 4 | 1 | 2 | 1 |
| Phase 3 | 1 | 0 | 0 | 1 |
| Phase 4 | 1 | 0 | 1 | 0 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| SUN Pharmaceutical Industries | Originator, Applicant and Lead sponsor of trials | 2017 to now |