Avutometinib
As of the edition of 20 October 2026, Avutometinib is a small molecule: marketed, first approved in 2025 (US); acts on MAP2K1 and MAP2K2; US protection ends in 2032.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2025
- Kind
- Small molecule
- Brand name
- Avmapki Fakzynja Co-Pack (copackaged)
- First approved
- 8 May 2025 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Verastem
- Registered trials
- 30, 1 stopped early
- Disease areas
- Cancer; Hormones; Digestive system; Pregnancy and women's health; Urinary and reproductive; Lungs and airways
US protection
US protection ends in 2032.
The last listed US exclusivity ends in 2032. The application that gives this date is held by Verastem.
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 product5 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
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Avutometinib.
See the 1 company-target row 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 1 | 7 | 3 | 4 | 0 |
| Phase 2 | 22 | 2 | 18 | 1 |
| Phase 3 | 1 | 0 | 1 | 0 |
| All trials | 30 |