EndoCyclic Therapeutics Receives FDA IND Clearance for First-in-Class Non-Hormonal Endometriosis Treatment ENDO-205
核心洞察
EndoCyclic Therapeutics (搜索) received FDA clearance for its Investigational New Drug application for ENDO-205 (搜索), a first-in-class non-hormonal peptide therapeutic targeting endometriosis (搜索) lesions.
Unlike existing hormone-based treatments that suppress symptoms, ENDO-205 (搜索) is designed to eliminate endometriosis (搜索) lesions and address underlying disease biology while avoiding systemic toxicity.
The company plans to initiate Phase 1 clinical trials in healthy pre-menopausal women, representing a potential breakthrough for over 190 million women worldwide affected by endometriosis (搜索).
EndoCyclic Therapeutics (搜索) announced that the U.S. Food and Drug Administration has cleared the company's Investigational New Drug application for ENDO-205 (搜索), a first-in-class, non-hormonal targeted peptide therapeutic for endometriosis (搜索). The Irvine, California-based biopharmaceutical company plans to initiate a Phase 1 clinical study in healthy pre-menopausal women of reproductive age.
Novel Mechanism Targets Disease Biology
Unlike existing therapies that primarily suppress symptoms through hormonal modulation, ENDO-205 (搜索) represents the first candidate in development designed to eliminate endometriosis (搜索) lesions and address associated symptoms, including pain and systemic complications. The therapeutic is built on EndoCyclic's proprietary precision peptide platform and is developed to target endometriosis lesions while acting only in diseased tissue.
"FDA IND clearance validates the strong scientific foundation behind ENDO-205 (搜索) 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 (搜索). "We are thrilled to advance ENDO-205 into the clinic as we pioneer the future of endometriosis (搜索) care and move closer to bringing patients a much-needed treatment for endometriosis."
Addressing Significant Unmet Medical Need
The milestone represents an important step forward for more than 190 million girls and women worldwide affected by endometriosis (搜索), which remains one of the most overlooked diseases in medicine according to Dr. Petrossian. Endometriosis is a chronic, progressive disease that affects approximately 10% of girls and women in their reproductive years and is characterized by the growth of endometrial-like tissue outside the uterus.
The disease serves as a leading cause of female infertility (搜索) and extends beyond its hallmark symptoms of pain to include associations with several comorbidities, including cardiovascular disease (搜索), increased risk of certain cancers, and other inflammatory conditions. Current medical therapies are largely hormone-based and symptomatic, failing to eliminate lesions or address the underlying disease biology driving persistent pain, recurrence, and ultimately the need for surgery.
Decade of Research and Development
ENDO-205 (搜索) represents the product of more than a decade of research designed to target the root cause and underlying biology of endometriosis (搜索). The therapeutic is engineered to avoid hormonal manipulation, surgical intervention, immune modulation, and systemic toxicity while specifically targeting endometriosis lesions.
In preclinical studies, ENDO-205 (搜索) demonstrated elimination of endometriosis (搜索) lesions and associated inflammation, with no safety signals observed in GLP toxicology studies. The program has received support from multiple NIH awards from the Eunice Kennedy Shriver National Institute of Child Health and Human Development and has been recognized as an NIH SBIR Success Story.
Recognition and Future Development
In 2025, ENDO-205 (搜索) 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 (搜索) was also recently selected as a founding member of the Milken Institute (搜索) Women's Health Network, a global collaborative advancing women's health research and innovation.
The company's pipeline extends beyond ENDO-205 (搜索) to include FemLUNA (搜索), an investigational imaging agent in development for accurate detection of endometriosis (搜索), including superficial lesions, as a potential non-invasive alternative to laparoscopy, the current gold standard for diagnosis. EndoCyclic is also expanding its precision peptide platform into additional women's health indications and oncology.