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Ranosidenib - HUTCHMED

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Drug Profile

Ranosidenib - HUTCHMED

Alternative Names: [14C] HMPL-306; HMPL-306

Latest Information Update: 20 Jun 2025

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At a glance

  • Originator Hutchison MediPharma
  • Developer HUTCHMED
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Isocitrate dehydrogenase 1 inhibitors; Isocitrate dehydrogenase 2 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 Acute myeloid leukaemia
  • Phase I Haematological malignancies; Solid tumours

Most Recent Events

  • 17 Jun 2025 Hutchmed plans a phase I trial for Glioma in China (PO) in July 2025(NCT07025018)
  • 15 Jan 2025 Hutchmed terminates a pPhase-I clinical trials in Haematological malignancies (Late-stage disease, Second-line therapy or greater) in USA, Spain (PO) based on strategic evaluation of the clinical development of HMPL-306 with no safety concerns (NCT04764474)
  • 26 Nov 2024 Hutchison MediPharma initiates enrolment in a phase I Mass Balance trial (In volunteers) in China(PO) (NCT06671873)

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