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Amezalpat - Tempest Therapeutics

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Drug Profile

Amezalpat - Tempest Therapeutics

Alternative Names: TPST 1120

Latest Information Update: 13 Nov 2025

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At a glance

  • Originator Tempest Therapeutics
  • Developer Roche; Sanofi; Tempest Therapeutics
  • Class Antineoplastics; Small molecules
  • Mechanism of Action PPAR alpha antagonists
  • Orphan Drug Status

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

    Yes - Liver cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Liver cancer
  • Phase I Solid tumours
  • Preclinical Haematological malignancies

Most Recent Events

  • 05 Nov 2025 Tempest Therapeutics plans a phase II TPST-1495 trial for Liver cancer (First-line therapy)
  • 30 Jun 2025 NMPA approves the regulatory application of amezalpat in China to proceed with the pivotal phase III TPST-1120-301 trial
  • 30 Jun 2025 Tempest Therapeutics receives agreement from the FDA and EMA on its phase III study design

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