PHILADELPHIA, July 31, 2026
Medicus Pharma Ltd. announced that the United Arab Emirates (UAE) Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) authorization for the company’s Phase 2a PRECISION-E2 clinical study evaluating Teverelix® in women with moderate-to-severe symptomatic endometriosis. The authorization follows a comprehensive regulatory review of the company’s chemistry, manufacturing and controls (CMC), non-clinical, clinical, and safety data, allowing the study to proceed following site-specific ethics and Institutional Review Board approvals. The randomized, placebo-controlled Phase 2a trial represents a significant regulatory milestone and positions Medicus Pharma at the forefront of genomics-guided precision medicine for women’s health. The company believes the study could help identify women most likely to benefit from long-acting GnRH antagonist therapy, while generating valuable clinical, pharmacodynamic, and genomic data to support future personalized treatment strategies.
PRECISION-E2 Integrates Genomics with Endometriosis Treatment
The PRECISION-E2 (Precision Estradiol Suppression and Genomic Response Study in Endometriosis) trial has been designed to move beyond conventional clinical development by prospectively integrating whole-genome analysis, endocrine pharmacology, pharmacokinetics, hormonal biomarkers, safety assessments, and patient-reported outcomes. Approximately 84 women with moderate-to-severe symptomatic endometriosis will be enrolled across multiple investigational sites in the UAE and randomized into four treatment groups receiving Teverelix® 60 mg subcutaneous, Teverelix® 90 mg subcutaneous, Teverelix® 90 mg intramuscular, or placebo. The study’s primary endpoint is the proportion of participants achieving and maintaining serum estradiol within the established Barbieri therapeutic window (20–50 pg/mL) for at least 14 consecutive days. Secondary and exploratory endpoints include pharmacokinetics, hormonal biomarkers, bone turnover markers, immunogenicity, pain reduction, quality-of-life improvements, and genomic analyses designed to identify potential treatment-response biomarkers.
Precision Medicine Approach Targets Significant Unmet Need
Endometriosis affects approximately one in ten women of reproductive age worldwide, causing chronic pelvic pain, infertility, menstrual discomfort, reduced quality of life, and substantial healthcare burden. Despite several available hormonal therapies, many patients continue to experience limited symptom control, adverse effects, disease recurrence, and inconsistent treatment responses. Medicus Pharma intends to evaluate whether Teverelix®, a next-generation, long-acting GnRH antagonist, can deliver rapid, controlled, and sustained estradiol suppression while minimizing unwanted hypoestrogenic effects. The study will also explore predefined genes involved in estrogen signaling, inflammation, reproductive hormone regulation, and pain pathways, including ESR1, ESR2, CYP19A1, GNRHR, FSHR, and LHCGR, potentially establishing one of the most comprehensive precision medicine datasets generated in endometriosis research.
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Teverelix Development Expands Across Multiple Therapeutic Areas
The UAE authorization strengthens Medicus Pharma’s broader clinical development strategy for Teverelix®, which is also being investigated for advanced prostate cancer, acute urinary retention associated with benign prostatic hyperplasia, and additional women’s health indications. According to the company, integrating genomic profiling, endocrine biomarkers, pharmacodynamic measurements, and clinical outcomes could optimize dose selection, route of administration, and future patient stratification strategies while creating opportunities for biomarker-guided therapeutic development. Although any candidate genomic biomarkers identified during PRECISION-E2 will require confirmation in future studies before clinical implementation, the trial represents an important step toward advancing personalized medicine in endometriosis. Successful completion of the study could support future regulatory development and strengthen Teverelix’s position as a differentiated therapy for estrogen-driven diseases.
Source: Medicus Pharma press release
