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Mirdametinib - SpringWorks Therapeutics

Drug Profile

Mirdametinib - SpringWorks Therapeutics

Alternative Names: PD-0325901; PD-325901

Latest Information Update: 11 Oct 2019

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At a glance

  • Originator Pfizer
  • Developer AstraZeneca; BeiGene; BIOENSIS; Pfizer; SpringWorks Therapeutics; 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 - Neurofibromatoses
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Neurofibromatoses
  • Phase I Solid tumours
  • Preclinical Cervical cancer; Chronic obstructive pulmonary disease
  • Discontinued Breast cancer; Cancer; Colorectal cancer; Malignant melanoma; Non-small cell lung cancer

Most Recent Events

  • 06 Sep 2019 SpringWorks Therapeutics initiates a phase IIb RENEU trial for Neurofibromatosis type 1-associated plexiform neurofibromas (NF1-assosciated PN) (In children, In adolescents, In adults, In the elderly) in USA (PO, Capsule) (NCT03962543)
  • 31 Jul 2019 Mirdametinib receives Orphan Drug status for Neurofibromatoses in European Union
  • 04 Jun 2019 PD 325901 receives Fast Track designation for Neurofibromatoses [PO] in USA
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