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Mirdametinib - SpringWorks Therapeutics

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Drug Profile

Mirdametinib - SpringWorks Therapeutics

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

Latest Information Update: 26 Oct 2026

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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

Highest Development Phases

  • Marketed 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

  • 26 Oct 2026 Merck Healthcare KGaA initiates a phase I pharmacokinetics trial in health volunteers in Germany (NCT07840612)
  • 03 Sep 2026 Phase-I clinical trials in Neurofibromatosis 1 (In children, In infants, In neonates, In adolescents) in Spain (PO) (CTIS2025-522000-24-00)
  • 03 Aug 2026 Merck KGaA plans a phase I trial in Neurofibromatosis 1 (In volunteers) in Germany (PO) (CTIS2026-526403-30-00)

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