Medicus Pharma received FDA "study may proceed" clearance to initiate a Phase 2b open-label dose-optimization trial of Teverelix in 40 men with advanced prostate cancer and high cardiovascular risk. The regimen includes a 540 mg loading dose (180 mg IM plus two 180 mg SC injections) followed by 360 mg SC every six weeks over approximately 22 weeks, with medical castration by Day 29 and sustained suppression to Day 155 as the primary endpoint.

Teverelix is a long-acting GnRH antagonist formulated for immediate receptor antagonism, avoiding the testosterone surge seen with agonists and potentially reducing cardiovascular risk in this patient population. Prostate cancer patients with elevated cardiovascular risk represent an estimated 300,000–500,000 men in the U.S., translating into a potential annual market exceeding US$4 billion for advanced prostate cancer and up to US$6 billion including acute urinary retention relapse prevention.

Based on prior FDA interactions, Medicus has aligned its registrational Phase 3 development pathway to seek a differentiated cardiovascular-risk–focused label for advanced prostate cancer hormone therapy. The company plans to leverage Phase 2 data for strategic partnerships and licensing discussions to support late-stage development and commercialization.

In parallel, Medicus completed enrollment of 90 basal cell carcinoma patients in its SkinJect dissolvable microneedle array Phase 2 trial, with topline decision-grade data expected in Q1 2026. An interim analysis showed over 60% clinical clearance in more than half of the initially randomized 60 patients, pending confirmation in the full dataset.