Dostarlimab
As of the edition of 20 October 2026, Dostarlimab is an antibody: marketed, first approved in 2021 (EU); acts on PDCD1; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Antibody
- Brand name
- Jemperli
- First approved
- 21 April 2021 (EU)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- GSK; 2 holders in all
- Registered trials
- 96, 16 stopped early
- Disease areas
- Cancer; Urinary and reproductive; Pregnancy and women's health; Digestive system; Lungs and airways; Hormones
US protection
US protection ends in 2033.
US protection ends in 2033, 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 GSK. 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
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 Dostarlimab.
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 | 2 | 0 | 1 | 0 |
| Phase 1 | 16 | 3 | 9 | 4 |
| Phase 2 | 64 | 9 | 41 | 11 |
| Phase 3 | 12 | 0 | 10 | 1 |
| Phase 4 | 2 | 0 | 2 | 0 |
| All trials | 96 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 2016 to now |