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ETX 636

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Drug Profile

ETX 636

Alternative Names: ETX-636; PI3Kα targeted therapeutic - ENSEM Therapeutics

Latest Information Update: 07 Oct 2025

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At a glance

  • Originator ENSEM Therapeutics
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Phosphatidylinositol 3 kinase alpha 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 I/II HER2 negative breast cancer

Most Recent Events

  • 01 Oct 2025 ETX 636 receives Fast Track designation for HER2-negative-breast-cancer [PO,Tablet] (Monotherapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA
  • 06 Jun 2025 Phase-I/II clinical trials in HER2-negative-breast-cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Monotherapy) in USA (PO) (NCT06993844)
  • 06 Jun 2025 Phase-I/II clinical trials in HER2-negative-breast-cancer (Second-line therapy or greater, Metastatic disease, Late-stage disease, Combination therapy) in USA (PO) (NCT06993844)

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