EndoCyclic New Drug application approved by US FDA for endometriosis treatment
Lucy Batizovsky | March 24, 2026 | News story | Research and Development |Â Â EndoCyclic Therapeutics, FDA, endometriosisÂ
EndoCyclic Therapeutics’ Investigational New Drug (IND) application for its lead programme, ENDO-205, has been approved by the US FDA.
With the approval, EndoCyclic plans to initiate a phase 1 clinical study evaluating the treatment in healthy pre-menopausal women of reproductive age.
Affecting approximately 10% of girls and women in their reproductive years, endometriosis is a chronic, progressive disease that causes the growth of endometrial-like tissue outside the uterus.
A first-in-class, non-hormonal targeted peptide therapeutic for endometriosis, ENDO-205 is designed to eliminate endometriosis lesions but not impact healthy tissue, avoiding hormonal manipulation, surgical intervention, immune modulation and systemic toxicity.
Tanya Petrossian, Founder and CEO of EndoCyclic Therapeutics, said: “[As we] advance ENDO-205 into the clinic, we pioneer the future of endometriosis care and move closer to bringing patients a much-needed treatment for endometriosis.
“This milestone marks an important step forward for the more than 190 million girls and women worldwide affected by endometriosis, which still remains one of the most overlooked diseases in medicine.”
Building on EndoCyclic’s proprietary precision peptide platform, over a decade of research went into designing ENDO-205 to target the root cause and underlying biology of endometriosis, a leading cause of female infertility.
Recognised as an NIH SBIR Success Story, the programme has been supported by multiple NIH awards from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and received an NIH Commercialisation Readiness Pilot grant with an overall impact score of ten.
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