For millions of women living with endometriosis, a new kind of hope just took a step forward.
The FDA has cleared EndoCyclic Therapeutics’ Investigational New Drug application for ENDO-205, allowing the company to begin human testing.
This does not mean the drug is approved.It means clinical trials can now begin.
The clearance, announced on March 23, 2026, paves the way for a Phase 1 study in healthy pre menopausal women of reproductive age to evaluate safety.
What makes ENDO-205 different? Most current endometriosis treatments work by shutting down hormones to dull pain. ENDO-205 takes a completely different route.
It is a first-in-class, non-hormonal precision peptide designed to find and eliminate endometriosis lesions themselves, while sparing healthy tissue.
The disease affects roughly 10% of girls and women more than 190 million worldwide and is a leading cause of chronic pain and infertility, yet it remains vastly overlooked.
Developed after more than 10 years of research and backed by NIH awards, the therapy avoids hormones, surgery, and systemic toxicity.
As CEO Dr. Tanya Petrossian noted, it is a move toward finally treating the root cause, not just the symptoms.
