Pralsetinib
As of the edition of 20 October 2026, Pralsetinib is a small molecule: marketed, first approved in 2020 (US); acts on RET; US protection ends in 2042.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Gavreto
- First approved
- 4 September 2020 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Withdrawn from market
- 24 October 2024 (in some regions)
- Registered trials
- 16, 2 stopped early
- Disease areas
- Cancer; Lungs and airways; Hormones; Digestive system; Inherited and neonatal; Skin and connective tissue
US protection
US protection ends in 2042.
The last listed US drug-substance patent ends in 2042. The application that gives this date is held by Rigel Pharmaceuticals.
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 product7 listings count 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 Pralsetinib.
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 |
|---|---|---|
| RET | Proto-oncogene tyrosine-protein kinase receptor Ret | P07949 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 0 | 3 | 0 |
| Phase 2 | 7 | 2 | 4 | 0 |
| Phase 3 | 2 | 0 | 0 | 2 |
| Phase 4 | 3 | 0 | 3 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Originator and Lead sponsor of trials | 2020 to now |
| Rigel Pharmaceuticals | Acquired holder and Lead sponsor of trials | 2024 to now |