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Pimicotinib - Abbisko Therapeutics

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Drug Profile

Pimicotinib - Abbisko Therapeutics

Alternative Names: ABSK-021

Latest Information Update: 16 Jun 2025

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At a glance

  • Originator Abbisko Therapeutics
  • Developer Abbisko Therapeutics; Sperogenix Therapeutics
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Macrophage colony-stimulating factor receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Giant cell tumours
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Giant cell tumour of tendon sheath
  • Phase III Solid tumours
  • Phase II Graft-versus-host disease; Pancreatic cancer
  • Phase I Unspecified
  • Preclinical Amyotrophic lateral sclerosis; Osteosarcoma

Most Recent Events

  • 10 Jun 2025 Merck plans to file a New Drug Application to the US Food and Drug Administration for pimicotinib in USA and other markets around the world
  • 10 Jun 2025 The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) accepts regulatory application for pimicotinib for Giant cell tumour of tendon sheath (In adults, In the elderly, Inoperable/Unresectable, Late-stage disease) (PO) for review
  • 28 May 2025 Preregistration for Giant cell tumour of tendon sheath (In the elderly, Inoperable/Unresectable, Late-stage disease, In adults) in China (PO)

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