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Mirdametinib - SpringWorks Therapeutics

Drug Profile

Mirdametinib - SpringWorks Therapeutics

Alternative Names: PD-0325901; PD-325901

Latest Information Update: 12 Mar 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
  • 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

  • 04 Mar 2024 Preregistration for Neurofibromatosis 1 (In adolescents, In children, In the elderly, Inoperable/Unresectable, In adults) in USA (PO)
  • 04 Mar 2024 SpringWorks Therapeutics announces intention to complete NDA submission to the US FDA for Neurofibromatosis 1 in the second quarter of 2024
  • 27 Feb 2024 SpringWorks Therapeutics receives patent allowance for mirdametinib in the US
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