EndoCyclic Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for ENDO-205. This marks a significant step towards a new era of endometriosis treatment, offering a first-in-class, non-hormonal precision peptide therapeutic aimed at directly addressing the disease’s root cause.
Key Takeaways
- FDA clearance for ENDO-205 IND application.
- ENDO-205 is a first-in-class, non-hormonal peptide therapeutic for endometriosis.
- Aims to eliminate lesions and associated symptoms, unlike current hormonal therapies.
- Phase 1 clinical study planned in healthy pre-menopausal women.
A New Approach to Endometriosis Care
EndoCyclic Therapeutics announced today that the FDA has cleared its IND application for ENDO-205, a groundbreaking therapeutic candidate for endometriosis. This development signifies a potential paradigm shift in how the chronic and often debilitating disease is treated. Unlike existing treatments that primarily focus on symptom management through hormonal modulation, ENDO-205 is designed to target and eliminate endometriosis lesions directly.
Pioneering Precision Peptide Therapy
Developed over a decade of research, ENDO-205 is built upon EndoCyclic’s proprietary precision peptide platform. The therapeutic is engineered to specifically target endometriosis lesions, acting only within diseased tissue. This targeted approach aims to avoid the systemic side effects associated with hormonal manipulation, surgical interventions, immune modulation, and general toxicity. Preclinical studies have shown promising results, including the elimination of endometriosis lesions and associated inflammation, with no observed safety concerns in toxicology studies.
Advancing into Clinical Trials
With the IND clearance secured, EndoCyclic Therapeutics is preparing to initiate a Phase 1 clinical study. This study will involve healthy pre-menopausal women of reproductive age. Dr. Tanya Petrossian, Founder and CEO of EndoCyclic Therapeutics, expressed enthusiasm about advancing ENDO-205 into clinical trials, stating, "FDA IND clearance validates the strong scientific foundation behind ENDO-205 and the work of our deeply experienced team… We are thrilled to advance ENDO-205 into the clinic as we pioneer the future of endometriosis care and move closer to bringing patients a much-needed treatment for endometriosis."
Addressing a Global Unmet Need
Endometriosis affects an estimated 10% of girls and women in their reproductive years worldwide, totaling over 190 million individuals. The disease, characterized by the growth of endometrial-like tissue outside the uterus, is a leading cause of infertility and is associated with significant pain, systemic complications, and an increased risk of certain cancers. Current treatments are largely symptomatic and hormone-based, often failing to eliminate lesions or address the underlying disease biology, leading to persistent pain, recurrence, and the frequent need for surgery. ENDO-205 represents a significant stride towards addressing this substantial unmet medical need.
Recognition and Future Development
The development of ENDO-205 has been supported by multiple awards from the National Institutes of Health (NIH), including recognition as an NIH SBIR Success Story. In 2025, the program received an NIH Commercialization Readiness Pilot grant with a perfect impact score, highlighting its scientific innovation and commercial viability. EndoCyclic Therapeutics was also recently named a founding member of the Milken Institute Women’s Health Network. Beyond ENDO-205, the company is also developing FemLUNA, an investigational imaging agent for endometriosis detection, and is expanding its precision peptide platform into other women’s health indications and oncology.
Sources
- EndoCyclic Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for ENDO-205, a
First-in-Class Non-Hormonal Precision Peptide Therapeutic for Endometriosis, BioSpace. - EndoCyclic Therapeutics Announces FDA Clearance of Investigational New Drug
(IND) Application for ENDO-205, a First-in-Class Non-Hormonal Precision
Peptide Therapeutic for Endometriosis, PR Newswire.
