Encorafenib
As of the edition of 20 October 2026, Encorafenib is a small molecule: marketed, first approved in 2018 (US); acts on BRAF; US protection ends in 2030.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2021
- Kind
- Small molecule
- Brand name
- Braftovi
- First approved
- 27 June 2018 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Pfizer; 4 holders in all
- Registered trials
- 85, 21 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Nervous system; Lungs and airways; Blood and lymph
US protection
US protection ends in 2030.
The last listed US exclusivity ends in 2030. The application that gives this date is held by Pfizer.
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 product20 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
3 companies on route B because of this drug.
Companies on route B for this drug
In the product3 companies are on route B because of Encorafenib.
See the 3 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| BRAF | Serine/threonine-protein kinase B-raf | P15056 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 6 | 2 | 3 | 1 |
| Phase 1 | 17 | 5 | 6 | 5 |
| Phase 2 | 53 | 15 | 21 | 14 |
| Phase 3 | 7 | 2 | 5 | 0 |
| Phase 4 | 2 | 0 | 1 | 1 |
| All trials | 85 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2011 to now |
| Pierre Fabre | Applicant and Lead sponsor of trials | 2018 to now |
| Ono Pharmaceutical | Applicant | 2019 to now |