Mirdametinib
Orphan DrugFDA Approved (2025)
Description
An oral MEK1/2 inhibitor for adults and children aged 2 years and older with neurofibromatosis type 1 and symptomatic, inoperable plexiform neurofibromas. FDA-approved February 2025.
Indications & Therapeutic Use
Neurofibromatosis type 1 (plexiform neurofibromas)
Linked Diseases:
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| Standard Marketing Authorization | — | — | Approved |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Mirdametinib
| Generic Name | mirdametinib |
| Brands | 1 brand available |
| Active Ingredient | mirdametinib |
| Drug Class | Neurofibromatosis type 1 (plexiform neurofibromas) |
| Manufacturer | SpringWorks Therapeutics |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Not Required |
| Reg. Status | FDA Approved (2025) |
| Countries | 1 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes