Pembrolizumab
As of the edition of 20 October 2026, Pembrolizumab is an antibody: marketed, first approved in 2014 (US); acts on PDCD1; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Antibody
- Brand name
- Keytruda
- First approved
- 4 September 2014 (US)
- Approvals on record
- 32 in 5 regions
- Holder of the most recent approval
- Merck & Co.; 2 holders in all
- Registered trials
- 2,366, 449 stopped early
- Disease areas
- Cancer; Lungs and airways; Skin and connective tissue; Urinary and reproductive; Digestive system; Pregnancy and women's health
US protection
US protection ends in 2031.
The orphan exclusivity ends in 2031 (it covers one use only). The application that gives this date is held by Merck & Co..
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 product3 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 3 listings behind itRequest access. Nothing is shown until you do.
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 Pembrolizumab.
See the 1 company 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 | 69 | 24 | 20 | 4 |
| Phase 1 | 535 | 200 | 202 | 111 |
| Phase 2 | 1,491 | 407 | 658 | 308 |
| Phase 3 | 262 | 85 | 147 | 25 |
| Phase 4 | 9 | 3 | 4 | 1 |
| All trials | 2,366 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck & Co. | Applicant, Earlier holder and Lead sponsor of trials | 2014 to now |