Mirdametinib - SpringWorks Therapeutics
Alternative Names: EZMEKLY; GOMEKLI; PD-0325901; PD-325901Latest Information Update: 17 Dec 2025
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
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Orphan Drug Status
Yes - Neurofibromatosis 1
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity Yes
- Available For Licensing Yes
Highest Development Phases
- Registered Neurofibromatosis 1
- Phase II Histiocytosis; Malignant melanoma; Vascular malformations
- Phase I/II Glioma; Solid tumours
- Phase 0 Nerve sheath neoplasms
- Preclinical Aortic aneurysm
- Discontinued Breast cancer; Cancer; Cervical cancer; Chronic obstructive pulmonary disease; Colorectal cancer; Non-small cell lung cancer
Most Recent Events
- 12 Dec 2025 SpringWorks Therapeutics plans phase I pharmacokinetics trial (In volunteers) in US in December 2025 (PO) (NCT07279233)
- 26 Nov 2025 Springworks Therapeutics plans a phase I trial for Neurofibromatosis 1 (In infants, In neonates, In children, In adolescents) in Germany and Spain (PO) (CTIS2025-522000-24-00)
- 13 Oct 2025 Phase-II clinical trials in Malignant melanoma (Late-stage disease, Metastatic disease, Second-line therapy or greater, Inoperable/Unresectable) in USA (PO) (NCT07237100)