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Mirdametinib - SpringWorks Therapeutics

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Drug Profile

Mirdametinib - SpringWorks Therapeutics

Alternative Names: PD-0325901; PD-325901

Latest Information Update: 02 Sep 2024

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At a glance

  • Originator Pfizer
  • Developer AstraZeneca; BeiGene; BIOENSIS; Memorial Sloan-Kettering Cancer Center; Pfizer; SpringWorks Therapeutics; St. Jude Childrens Research Hospital; University of Oxford
  • Class Aniline compounds; Anti-inflammatories; Antineoplastics; Benzamides; Immunotherapies; 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

  • Preregistration Neurofibromatosis 1
  • Phase I/II Glioma; Solid tumours
  • Preclinical Rhabdoid tumour; Teratoma
  • No development reported Cervical cancer; Chronic obstructive pulmonary disease
  • Discontinued Breast cancer; Cancer; Colorectal cancer; Malignant melanoma; Non-small cell lung cancer

Most Recent Events

  • 02 Sep 2024 FDA assigns PDUFA action date of (28/02/2025) for Mirdametinib for Neurofibromatosis 1
  • 29 Aug 2024 Mirdametinib receives priority review status for Neurofibromatosis 1 in USA
  • 28 Aug 2024 Preregistration for Neurofibromatosis 1 (In children, In adults, In the elderly, In adolescents) in European Union (PO)

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