Mirdametinib · Gomekli, PD-0325901

What is Mirdametinib?

Mirdametinib is a small-molecule inhibitor of MEK1/2 kinases, which are upstream regulators of the ERK pathway. It selectively binds to and inhibits MEK, reducing phosphorylation and activation of MAPK/ERK and inhibiting tumor cell proliferation.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as

Gomekli, PD-0325901, PD-901

Drug type

Small molecule

Targets

MEK1 (MAP2K1), MEK2 (MAP2K2)

Mechanism

Inhibitor of MEK1 (MAP2K1) and MEK2 (MAP2K2)

Pathways

MAPK/ERK, RAS/RAF/MEK/ERK signaling

Therapy area

Oncology

Developer

Springworks

In trials of

MRK

FDA status

Approved as Gomekli (February 11, 2025), NDA219379 · FDA label

UNII

86K0J5AK6M

✅ FDA-approved uses

• Neurofibromatosis type 1 with symptomatic plexiform neurofibromas not amenable to complete resection

From the indications section of the FDA label (version of Jul 10, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Neurofibromatosis Type 1-Associated Plexiform Neurofibromas

Other drugs acting on MAP2K1 / MAP2K2

Sources

• FDA label (DailyMed)
• FDA label Gomekli (2026-07-10), indications
• NCI Thesaurus
• ClinicalTrials.gov NCT07850635

Updated Oct 3, 2026.