Medicus Secures United Arab Emirates DOH Authorization For Phase 2a Teverelix Trial In Endometriosis
(RTTNews) - Medicus Pharma Ltd. (MDCX) announced that the Department of Health (DOH) - Abu Dhabi has granted Investigational New Drug (IND) authorization, for the Phase 2a PRECISION-E2 genomics-enabled trial to evaluate Teverelix in women with symptomatic endometriosis in the United Arab Emirates (UAE).
Endometriosis is a chronic estrogen-dependent inflammatory disease associated with debilitating pelvic pain, dysmenorrhea, infertility, and significantly impaired quality of life. The disease affects approximately one in ten women who are of reproductive age worldwide.
Teverelix is also known as Teverelix trifluroacetate, a gonadotrophin-releasing hormone (GnRH) antagonist developed by its subsidiary Antev Ltd. It is designed o to suppress the effect of reproductive hormones without the initial hormonal flare.
The IND authorization follows the Department of Health's review of the company's chemistry, manufacturing and controls (CMC), non-clinical, clinical and safety documentation.
The study was approved subject to site-specific Institutional Review Board (IRB) and ethics approvals.
PRECISION-E2 is a Phase 2a, randomized, placebo-controlled clinical study that will assess the pharmacodynamics, safety, tolerability, clinical activity, and genomic correlation of teverelix in women with moderate-to-severe symptomatic endometriosis. The trial will enroll approximately 84 participants in the UAE.
The company indicated that it would evaluate three treatment regimens for teverelix, which include 60 mg and 90 mg administered subcutaneously along with 90 mg intramuscular administration.
The primary goal is to identify the proportion of participants achieving and maintaining serum estradiol levels within the established Barbieri therapeutic window of approximately 20-50 pg/mL for at least 14 consecutive days following treatment.
Secondary and exploratory endpoints include pharmacokinetic parameters, hormonal biomarkers, bone turnover biomarkers, safety, immunogenicity, endometriosis-associated pain, quality-of-life assessments and exploratory genomic analyses.
Notably, PRECISION-E2 study has been designed to combine:
• Whole-genome information from participating women, subject to applicable approvals and governance requirements.
• Hormonal pharmacodynamics, including estradiol, luteinizing hormone and follicle-stimulating hormone. • Pharmacokinetic exposure and Bone turnover biomarkers.
• Clinical symptom improvement and patient-reported quality-of-life outcomes. • Safety and tolerability
• Exploratory analyses will evaluate genes and pathways associated with estrogen signaling, endometriosis, inflammation and pain perception, including ESR1, ESR2, CYP19A1, GNRHR, FSHR and LHCGR. Raza Bokhari, Executive Chairman and Chief Executive Officer (CEO), said PRECISION-E2 could support the future development of Teverelix and advance personalised treatment for endometriosis and other estrogen-driven health indications.
MDCX trade closed Friday (31.07.2026) at $0.27, up 4.80%. In overnight trading, the stock is up 4.36% at $0.28.
