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Serabelisib - ARTham Therapeutics

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Drug Profile

Serabelisib - ARTham Therapeutics

Alternative Names: ART-001; KP-001

Latest Information Update: 09 Feb 2026

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At a glance

  • Originator ARTham Therapeutics
  • Developer ARTham Therapeutics; Kaken Pharmaceutical
  • Class 2 ring heterocyclic compounds; Amines; Antineoplastics; Benzoxazoles; Cardiovascular therapies; Imidazoles; Ketones; Morpholines; Pyridines; Small molecules
  • Mechanism of Action Phosphatidylinositol 3 kinase alpha inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Vascular malformations

Most Recent Events

  • 09 Feb 2026 Chemical structure information added.
  • 23 Dec 2025 Kaken Pharmaceutical plans a phase III trial in Vascular malformations and Klippel Trenaunay Weber syndrome (In children, In adolescents, In adults, In the elderly) in North America, Canada, Taiwan and South Korea (PO) (NCT07285005)
  • 10 Nov 2025 Kaken Pharmaceutical plans to file marketing authorisation in Japan in 2026

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