Binimetinib
As of the edition of 20 October 2026, Binimetinib is a small molecule: marketed, first approved in 2018 (US); acts on MAP2K1 and MAP2K2; US protection ends in 2033.
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
- Mektovi
- First approved
- 27 June 2018 (US)
- Approvals on record
- 7 in 4 regions
- Holder of the most recent approval
- Pfizer; 4 holders in all
- Registered trials
- 130, 34 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Lungs and airways; Hormones; Nervous system
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. 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 product3 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
6 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product6 company-target rows are on route B because of Binimetinib.
See the 6 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 5 | 2 | 2 | 1 |
| Phase 1 | 41 | 19 | 7 | 14 |
| Phase 2 | 75 | 29 | 25 | 17 |
| Phase 3 | 7 | 3 | 3 | 1 |
| Phase 4 | 2 | 0 | 1 | 1 |
| All trials | 130 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Pfizer | Originator, Applicant and Lead sponsor of trials | 2008 to now |
| Pierre Fabre | Applicant and Lead sponsor of trials | 2018 to now |
| Ono Pharmaceutical | Applicant | 2019 to now |