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Endoxifen - Atossa Therapeutics

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Drug Profile

Endoxifen - Atossa Therapeutics

Alternative Names: (Z)-endoxifen

Latest Information Update: 22 Sep 2025

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At a glance

  • Originator Atossa Genetics
  • Developer Atossa Therapeutics; Weill Cornell Medicine
  • Class Antineoplastics; Methylamines; Phenyl ethers; Small molecules; Stilbenes
  • Mechanism of Action Estrogen receptor antagonists; Selective estrogen receptor modulators
  • Orphan Drug Status

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

    No
  • New Molecular Entity No

Highest Development Phases

  • Phase II Breast cancer; Ductal carcinoma; HER2 negative breast cancer
  • Preclinical Triple negative breast cancer
  • No development reported Gynaecomastia; Ovarian cancer

Most Recent Events

  • 08 Sep 2025 Atossa Therapeutics plans a Type C meeting with the US FDA to discuss regulatory strategies for development of low-dose (Z)-endoxifen for Breast cancer risk reduction in 2025.
  • 20 Aug 2025 Atossa Therapeutics plans a phase II trial in Breast cancer and HER2 negative breast cancer (Metastatic disease, Monotherapy, Combination therapy)
  • 12 Aug 2025 Efficacy and adverse event data from the phase II I-SPY trial in Breast cancer released by Atossa Therapeutics

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