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Atossa Therapeutics Announces Issuance of U.S. Patent Covering Enteric Oral (Z)-Endoxifen Formulations and Methods of Treating Patients Using (Z)-Endoxifen

ATOS
  • Atossa Therapeutics received U.S. Patent No. 12,479,790 B2 from the USPTO on Dec. 9, 2025, titled "Methods for Making and Using Endoxifen."
  • The patent contains 100 claims covering enteric oral formulations of highly pure (Z)-endoxifen free base, solid oral dosage forms, & methods to treat hormone-dependent breast disorders.
  • The patent protects stable formulations designed to provide sustained systemic exposure to (Z)-endoxifen & scalable manufacturing processes.
  • CEO Steven Quay states the patent strengthens Atossa's intellectual property estate to support (Z)-endoxifen development across the breast cancer spectrum & other hormone-driven conditions.
  • Atossa is advancing (Z)-endoxifen in metastatic breast cancer via a dose-ranging study, in neoadjuvant ER+/HER2- breast cancer through the Phase 2 EVANGELINE trial, & in breast cancer risk-reduction using a low-dose strategy.
  • The growing patent portfolio aims to secure long-term exclusivity for (Z)-endoxifen formulations, manufacturing, & therapeutic uses globally.
  • (Z)-endoxifen is a potent SERM that inhibits estrogen receptors, promotes receptor degradation, & targets the oncogenic protein PKCβ1.