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Pimicotinib - Abbisko Therapeutics

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Drug Profile

Pimicotinib - Abbisko Therapeutics

Alternative Names: ABSK-021

Latest Information Update: 20 Jan 2026

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At a glance

  • Originator Abbisko Therapeutics
  • Developer Abbisko Therapeutics; Sperogenix Therapeutics
  • Class Amides; Antineoplastics; Ethers; Pyrazoles; Pyridines; Pyrrolidinones; 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

Highest Development Phases

  • Registered Giant cell tumour of tendon sheath
  • Phase III Solid tumours
  • Phase II Graft-versus-host disease; Pancreatic cancer
  • No development reported Amyotrophic lateral sclerosis

Most Recent Events

  • 13 Jan 2026 Preregistration for Giant cell tumour of tendon sheath (Inoperable/Unresectable, Late-stage disease) in USA (PO)
  • 13 Jan 2026 US FDA accepts NDA for pimicotinib for Giant cell tumour of tendon sheath for review
  • 22 Dec 2025 Registered for Giant cell tumour of tendon sheath (Late-stage disease, Inoperable/Unresectable) in China (PO) - First global approval

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