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Revumenib - Syndax Pharmaceuticals

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Drug Profile

Revumenib - Syndax Pharmaceuticals

Alternative Names: Revuforj; SNDX-5613

Latest Information Update: 30 Jun 2025

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At a glance

  • Originator Vitae Pharmaceuticals
  • Developer Syndax Pharmaceuticals
  • Class Antineoplastics; Aza compounds; Benzamides; Cyclohexanes; Pyrimidines; Small molecules; Spiro compounds; Sulfonamides
  • Mechanism of Action KMT2A protein inhibitors; Menin inhibitors; Protein-protein interaction inhibitors
  • Orphan Drug Status

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

    Yes - Leukaemia; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute biphenotypic leukaemia; Acute myeloid leukaemia; Precursor cell lymphoblastic leukaemia-lymphoma
  • Phase II Leukaemia
  • Phase I/II Colorectal cancer; Solid tumours

Most Recent Events

  • 24 Jun 2025 FDA assigns PDUFA action date of 25/10/2025 for Revumenib for Acute myeloid leukemia
  • 24 Jun 2025 The US FDA grants priority review for supplemental New Drug Application for Revumenib for Acute myeloid leukemia in USA
  • 12 Jun 2025 Efficacy and adverse events data from the phase I/II AUGMENT-101 trial in Acute myeloid leukaemia released by Syndax Pharmaceuticals

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