Drug Profile

Mirdametinib - SpringWorks Therapeutics

Alternative Names: GOMEKLI; PD-0325901; PD-325901

Latest Information Update: 04 Jul 2025

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At a glance

Originator Pfizer
Developer BeOne Medicines; Pfizer; SpringWorks Therapeutics; St. Jude Childrens Research Hospital
Class Aniline compounds; Antineoplastics; Benzamides; Fluorinated hydrocarbons; Iodinated hydrocarbons; Small molecules
Mechanism of Action MAP kinase kinase 1 inhibitors; MAP kinase kinase 2 inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Neurofibromatosis 1
New Molecular Entity Yes
Available For Licensing Yes

Registered Neurofibromatosis 1
Phase II Histiocytosis; Vascular malformations
Phase I/II Glioma; Solid tumours
Phase 0 Nerve sheath neoplasms
Discontinued Breast cancer; Cancer; Cervical cancer; Chronic obstructive pulmonary disease; Colorectal cancer; Malignant melanoma; Non-small cell lung cancer

01 Jul 2025 SpringWorks Therapeutics has been acquired by Merck KGaA
23 May 2025 SpringWorks Therapeutics expects decision from European Commission for mirdametinib for Neurofibromatosis 1 (PO), in the third quarter of 2025
23 May 2025 The CHMP adopts positive opinion recommending the granting of a conditional marketing authorisation for mirdametinib for Neurofibromatosis 1 in paediatric and adult patients

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