Teverelix - (PRECISION-E2)
- Indication
- Hormone-driven conditions, including endometriosis and uterine fibroids, Moderate-to-severe symptomatic endometriosis
- Stage
- phase2
- Event
- Phase 2a
- Details
July 31, 2026: Medicus Pharma Ltd. (NASDAQ: MDCX) said the UAE Department of Health–Abu Dhabi granted IND authorization for the PRECISION-E2 Phase 2a study of Teverelix in women with moderate-to-severe symptomatic endometriosis, allowing the study to proceed pending site-specific IRB and ethics approvals.
PRECISION-E2 is a prospective, randomized, placebo-controlled Phase 2a trial in about 84 women at multiple UAE sites. Patients will be randomized to Teverelix 60 mg SC, Teverelix 90 mg SC, Teverelix 90 mg IM, or placebo SC. The primary pharmacodynamic endpoint is the proportion of participants achieving and maintaining serum estradiol within the Barbieri therapeutic window of about 20–50 pg/mL for at least 14 consecutive days after treatment.
Secondary/exploratory endpoints include pharmacokinetics, hormonal and bone turnover biomarkers, safety, immunogenicity, endometriosis-associated pain, quality of life, and genomic analyses. The company said the trial is designed to evaluate dose and route while exploring biomarkers and multi-gene response signatures; any such biomarkers would need confirmation in later studies before patient-selection use.
The release also notes Teverelix is in development for advanced prostate cancer with elevated cardiovascular risk and recurrence of acute urinary retention associated with benign prostatic hyperplasia.
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