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Safusidenib - AnHeart Therapeutics

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Drug Profile

Safusidenib - AnHeart Therapeutics

Alternative Names: AB-218; DS-1001; DS-1001b

Latest Information Update: 26 Oct 2026

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At a glance

  • Originator Daiichi Sankyo Company; National Cancer Center (Tokyo)
  • Developer AnHeart Therapeutics; Daiichi Sankyo Company; National Cancer Center (Tokyo); Nuvation Bio
  • Class Alkenes; Antineoplastics; Carboxylic acids; Chlorobenzenes; Fluorinated hydrocarbons; Indoles; Isoxazoles; Ketones; Small molecules
  • Mechanism of Action Isocitrate dehydrogenase 1 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 Glioma
  • No development reported Acute myeloid leukaemia; Chondrosarcoma; Solid tumours
  • Discontinued Cholangiocarcinoma

Most Recent Events

  • 20 Oct 2026 Phase-II clinical trials in Glioma (Second-line therapy or greater) in USA (PO) (NCT07703436)
  • 21 Sep 2026 University of Zurich in collaboration with Nuvation Bio plans a phase II SAFU-G3 trial for Oligodendroglioma and Astrocytoma (First line therapy) in Switzerland (PO) (NCT07832123)
  • 20 Aug 2026 Safusidenib receives Fast Track designation for Glioma [PO] (Recurrent, Second-line therapy or greater, Late-stage disease) in USA

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