Medicus Pharma cleared by FDA for registrational Phase 2b trial in patients with Gorlin Syndrome
Last updated: 12:15 27 Jul 2026 EDT, First published: 11:15 27 Jul 2026 EDT
Medicus Pharma CEO Dr Raza Bokhari joined Steve Darling from Proactive to discuss the company's receipt of a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA), authorizing the start of its NDA-enabling Phase 2b clinical trial for SkinJect® in patients with Gorlin Syndrome.
The FDA clearance follows the company's submission of the SKNJCT-005 study protocol and its response to the agency's June 2026 information requests, completing the safety review of the Investigational New Drug (IND) application.
The Phase 2b, open-label, multicenter trial will evaluate SkinJect® 200 mcg in up to 50 patients with Gorlin Syndrome who develop multiple basal cell carcinomas (BCCs) requiring repeated surgical treatment. The study is designed to generate the efficacy and safety data needed to support a future New Drug Application (NDA).
Gorlin Syndrome is a rare inherited genetic disorder linked to abnormalities in the Hedgehog signaling pathway, causing patients to develop numerous basal cell carcinomas beginning in childhood or early adulthood. Many patients undergo repeated surgeries throughout their lives, often resulting in scarring, functional impairment, and significant quality-of-life challenges.
Bokhari said the FDA authorization marks a major regulatory milestone, allowing Medicus to advance SkinJect® into a registrational study that could provide a less invasive treatment option for patients living with this rare disease.
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