Cemiplimab
As of the edition of 20 October 2026, Cemiplimab is an antibody: marketed, first approved in 2018 (US); acts on PDCD1; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Antibody
- Brand name
- Libtayo
- First approved
- 28 September 2018 (US)
- Approvals on record
- 5 in 3 regions
- Holder of the most recent approval
- Sanofi; 4 holders in all
- Registered trials
- 212, 30 stopped early
- Disease areas
- Cancer; Lungs and airways; Skin and connective tissue; Urinary and reproductive; Pregnancy and women's health; Digestive system
US protection
US protection ends in 2030.
US protection ends in 2030, 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 Regeneron. 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.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Cemiplimab.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PDCD1 | Programmed cell death protein 1 | Q15116 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 2 | 6 | 0 |
| Phase 1 | 41 | 9 | 22 | 9 |
| Phase 2 | 145 | 14 | 104 | 20 |
| Phase 3 | 16 | 3 | 11 | 1 |
| All trials | 212 |