Prescription medicine

Mirdametinib Brand names: Gomekli

Mirdametinib (Gomekli) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the mirdametinib FDA label on DailyMed (effective July 10, 2026, SpringWorks Therapeutics, Inc.); the NDA 219389 record on Drugs@FDA; every mirdametinib label on DailyMed.

Highlights of the record

FDA label of July 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
GOMEKLI is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection [see Clinical Studies (14) ].

Forms and strengths

1 mg
2 mg

Capsule; tablet for suspension.

On the market

Earliest approval on file: February 11, 2025 Gomekli, Springworks; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: October 10, 2044 Gomekli capsules; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is mirdametinib used for?

From the label: indications and usage
GOMEKLI is indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection [see Clinical Studies (14) ]. GOMEKLI is a kinase inhibitor indicated for the treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection.

FDA pharmacologic class: Kinase Inhibitor.

Source: FDA drug label (Gomekli), SpringWorks Therapeutics, Inc., effective July 10, 2026 (SPL set 4c41bf90-5fa7-4935-a95c-e047ea6bbf8e), via openFDA; the full label on DailyMed

Is there a generic for mirdametinib (Gomekli)?

No generic mirdametinib is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 20 patents for Gomekli capsules: the compound patent runs to February 17, 2041, and the last listed entry to October 10, 2044. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2025 earliest approval on file
2044 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Other kinase inhibitors: the pharmacologic class, with prices and generics
Check an interaction: what two or more labels say about each other