Mirdametinib
As of the edition of 20 October 2026, Mirdametinib is a small molecule: marketed, first approved in 2025 (US); acts on MAP2K1; US protection ends in 2041.
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
- Gomekli
- First approved
- 11 February 2025 (US)
- Approvals on record
- 6 in 2 regions
- Holder of the most recent approval
- Merck KGaA; 2 holders in all
- Registered trials
- 28, 4 stopped early
- Disease areas
- Cancer; Nervous system; Inherited and neonatal; Skin and connective tissue; Blood and lymph; Digestive system
US protection
US protection ends in 2041.
The last listed US drug-substance patent ends in 2041. The application that gives this date is held by Merck KGaA.
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
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 Mirdametinib.
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 |
|---|---|---|
| MAP2K1 | Dual specificity mitogen-activated protein kinase kinase 1 | Q02750 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 0 | 0 | 0 |
| Phase 1 | 7 | 4 | 2 | 1 |
| Phase 2 | 19 | 3 | 12 | 3 |
| All trials | 28 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Originator, Applicant and Lead sponsor of trials | 2023 to now |