EndoCyclic Therapeutics ENDO-205 IND Cleared March 23, 2026: First-in-Class Non-Hormonal Precision Peptide Therapeutic for Endometriosis Designed to Eliminate Lesions Rather Than Suppress Symptoms
EndoCyclic Therapeutics announced FDA clearance of the Investigational New Drug (IND) application for ENDO-205 on March 23, 2026. ENDO-205 is a first-in-class non-hormonal precision peptide therapeutic for endometriosis, designed to eliminate lesions rather than modulate hormones — distinguishing it from all currently approved endometriosis therapies, which are either oral GnRH antagonists (elagolix, relugolix) or hormonal contraceptives. In preclinical models, ENDO-205 eliminated endometriosis lesions and associated inflammation with no safety signals in GLP toxicology studies. The Phase 1 will enroll healthy pre-menopausal women of reproductive age. Endometriosis affects roughly 10% of women of reproductive age globally, with a 6-10 year average diagnostic delay and no curative therapy.