Sol-Gel completes patient follow-up in Gorlin syndrome Phase 3 trial

Sol-Gel Technologies said on September 17, 2026 that the last patient enrolled in its pivotal Phase 3 trial of SGT-610, known as patidegib gel 2%, has finished the last scheduled study visit. The trial, designated SGT-610-01, is testing whether the drug can prevent basal cell carcinoma lesions in adult patients with Gorlin syndrome.¹

The company said reaching this last patient last visit milestone marks the end of the treatment and follow-up portion of the study.¹ Sol-Gel is now moving to lock the database and begin statistical analysis.¹ The company still expects to report top-line results in late November 2026.¹ Sol-Gel, the investigators and the patients remain blinded to treatment assignment.¹

On trial design, Sol-Gel said the randomized, double-blind, vehicle-controlled study enrolled 113 patients with Gorlin syndrome, of whom 102 completed it, with patients randomized to receive either SGT-610 or vehicle over 12 months of treatment.¹ The primary endpoint is the number of new basal cell carcinomas on the face at month 12 following twice-daily treatment.¹ A secondary endpoint tracks the number of new surgically eligible basal cell carcinomas.¹

Mori Arkin, Sol-Gel's Executive Chairman and CEO, said reaching this milestone was significant for the SGT-610 program and said the company looks forward to completing the analysis and reporting results, according to the release.

Sol-Gel described itself as a specialized dermatology company advancing therapies for rare and serious skin diseases.¹ It noted it is also developing SGT-210, an investigational topical EGFR inhibitor, and has two FDA-approved dermatology products, TWYNEO and EPSOLAY.¹