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

IRVINE, Calif., March 23, 2026 /PRNewswire/ -- EndoCyclic Therapeutics, a biopharmaceutical company developing precision peptide therapeutics and diagnostics for complex diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for its lead program, ENDO-205, a first-in-class, non-hormonal targeted peptide therapeutic for endometriosis. The company plans to initiate a Phase 1 clinical study in healthy pre-menopausal women of reproductive age.

Unlike existing therapies that primarily suppress symptoms through hormonal modulation, ENDO-205 is the first candidate in development designed to eliminate endometriosis lesions and address associated symptoms, including pain and systemic complications.

"FDA IND clearance validates the strong scientific foundation behind ENDO-205 and the work of our deeply experienced team in R&D, regulatory affairs, and product development," said Dr. Tanya Petrossian, Founder and CEO of EndoCyclic Therapeutics. "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. 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."

ENDO-205 is the product of more than a decade of research designed to target the root cause and underlying biology of endometriosis. Built on EndoCyclic's proprietary precision peptide platform, ENDO-205 is developed to target endometriosis lesions and act only in diseased tissue while avoiding hormonal manipulation, surgical intervention, immune modulation, and systemic toxicity. In preclinical studies, ENDO-205 demonstrated elimination of endometriosis lesions and associated inflammation, with no safety signals observed in GLP toxicology studies.

The program has been supported by multiple NIH awards from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and has been recognized as an NIH SBIR Success Story. In 2025, ENDO-205 received an NIH Commercialization Readiness Pilot grant with a rare "unicorn" perfect overall impact score of 10, reflecting the highest level of scientific innovation, research rigor, and commercial viability. EndoCyclic Therapeutics was also recently selected as a founding member of the Milken Institute Women's Health Network, a global collaborative advancing women's health research and innovation.  

About Endometriosis

Endometriosis is a chronic, progressive disease that affects approximately 10% of girls and women in their reproductive years. It is characterized by the growth of endometrial-like tissue outside the uterus and is a leading cause of female infertility. Beyond its hallmark symptoms of pain, endometriosis has been associated with several comorbidities, including cardiovascular disease, increased risk of certain cancers, and other inflammatory conditions. Current medical therapies are largely hormone-based and symptomatic, and do not eliminate lesions or address the underlying disease biology driving persistent pain, recurrence, and ultimately the need for surgery. Endometriosis remains a highly prevalent and underserved therapeutic area with significant unmet medical need and limited innovation, underscoring the opportunity for novel targeted approaches that can directly eliminate endometriosis lesions and its associated symptoms.

About EndoCyclic Therapeutics

EndoCyclic Therapeutics is a biopharmaceutical company focused on the discovery and development of best-in-class and first-in-class precision peptide therapeutics and diagnostics to address complex diseases of high unmet need in women's health and oncology. Its lead programs include ENDO-205, an investigational non-hormonal therapeutic for endometriosis, and FemLUNA, an investigational imaging agent in development for accurate detection of endometriosis, including superficial lesions, as a potential non-invasive alternative to laparoscopy, the current gold standard for diagnosis. The company is also expanding its precision peptide platform into additional women's health indications and oncology.

EndoCyclic Therapeutics is headquartered in Irvine, California. For more information, visit www.endocyclictherapeutics.com and follow the company on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements regarding ENDO-205, FemLUNA, the potential of the Company's product candidates, planned clinical development, regulatory progress, and other pipeline programs. Actual results may differ materially from those expressed or implied due to risks and uncertainties inherent in drug development, regulatory review, and commercialization.

Media Contact

Raena Mina, Ph.D.
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SOURCE EndoCyclic Therapeutics