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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: 29 Jul 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.

    Yes - Vascular malformations
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Vascular malformations
  • Phase III Klippel-Trenaunay-Weber syndrome

Most Recent Events

  • 17 Jul 2026 Efficacy and adverse events data from a phase III trial in vascular malformations released by Kaken Pharmaceutical
  • 15 May 2026 Preregistration for Vascular malformations (Second-line therapy or greater, In adolescents, In children, In adults, In the elderly) in Japan (PO)
  • 15 May 2026 Kaken Pharmaceutical files an regulatory application with the Ministry of Health, Labour and Welfare (MHLW) in Japan for vascular malformations

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