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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: 10 Dec 2025

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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)
  • Class Antineoplastics
  • 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 II Glioma
  • Phase I Cholangiocarcinoma; Solid tumours
  • No development reported Acute myeloid leukaemia; Chondrosarcoma

Most Recent Events

  • 03 Dec 2025 Efficacy and adverse events data from a phase-II trial in Glioma released by Nuvation Bio
  • 28 Nov 2025 No recent reports of development identified for phase-I development in Glioma(Neoadjuvant therapy) in Austria (PO)
  • 03 Nov 2025 Nuvation Bio completes a meeting with US FDA for protocol amendment

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