Patidegib Gel Completes Phase 3 Follow-Up in Gorlin Syndrome

Sol-Gel Technologies recently announced last patient last visit (LPLV) in its pivotal phase 3 trial of patidegib gel, 2% (SGT-610) for the prevention of basal cell carcinoma (BCC) lesions in adults with Gorlin syndrome.¹ The randomized, double-blind, vehicle-controlled study, SGT-610-01, enrolled 113 patients, of whom 102 completed 12 months of treatment. Sol-Gel is proceeding to database lock and statistical analysis, with top-line results expected in late November 2026.

No FDA-approved topical therapy currently targets BCC prevention in Gorlin syndrome, and the only approved systemic options are oral hedgehog inhibitors, whose long-term tolerability limits chronic use. SGT-610 carries Orphan Drug and Breakthrough Therapy designations from the FDA, reflecting its potential as a chronic, topical alternative for a population managed largely through surveillance and surgical excision.¹ Both the company and investigators remain blinded to treatment assignment ahead of database lock.

The SGT-610-01 trial (NCT06050122) is a multicenter, randomized, double-blind, vehicle-controlled phase 3 study evaluating SGT-610 in adults with Gorlin syndrome. Patients were randomized to apply SGT-610 or vehicle gel to the face twice daily for 12 months. Of the 113 patients enrolled, 102 completed the full treatment and follow-up period, with the remainder discontinuing before LPLV.^1,2

Blinding was maintained throughout the study for patients, investigators, and Sol-Gel. The primary end point is the number of new BCCs on the face at month 12, compared between the SGT-610 and vehicle arms. Sol-Gel has not unblinded treatment assignments and does not report efficacy data at this stage.

With patient follow-up complete, the company is moving to database lock, a required step before formal statistical analysis of the primary and secondary end points can begin. Top-line results, including the primary end point outcome, are expected in late November 2026.

Mori Arkin, executive chairman and CEO of Sol-Gel Technologies, credited the trial's completion to the patients, investigators, and site teams who took part. "Reaching last patient last visit represents an important milestone for the SGT-610 program and brings us closer to understanding its potential to address the significant unmet need in patients with Gorlin syndrome," Arkin said. "We look forward to completing the analysis and reporting the results."

Secondary End Points, Safety Data, and Phase 3 Timeline

Secondary end points in SGT-610-01 include the number of new surgically eligible BCCs (SEBCCs), a measure capturing lesions requiring surgical intervention rather than observation. Because the trial remains fully blinded, Sol-Gel has not disclosed comparative data for either the primary or secondary end points at LPLV. Safety data collected during the 12-month treatment period will be included in the planned analysis and reported alongside efficacy results.

The company has not identified interim safety signals prompting early unblinding or protocol changes. Following database lock, statistical analysis will encompass the primary end point and secondary measures such as SEBCC counts. Sol-Gel expects top-line results, including safety findings, in late November 2026.

SEBCC data are intended to characterize disease burden beyond simple BCC counts, capturing lesions requiring surgical excision or destruction rather than observation alone. Investigators tracked all facial BCCs by photography and dermoscopy throughout the 12-month period. These procedures aim to standardize lesion counting across the trial's multiple sites ahead of database lock.

SGT-610 is one of two clinical-stage candidates in Sol-Gel's pipeline targeting rare, high-need dermatologic conditions, alongside SGT-210, an investigational topical EGFR inhibitor. If the primary end point is met, patidegib gel could offer a chronic, topical option for a population currently managed largely through surveillance and surgical excision. Sol-Gel's existing FDA-approved products, Twyneo and Epsolay, are marketed for other dermatologic indications through a partnership with Galderma.

References

1. Sol-Gel Technologies announces last patient last visit in pivotal phase 3 clinical trial of SGT-610 in Gorlin syndrome. News release. Sol-Gel Technologies. September 17, 2026. Accessed September 17, 2026. https://ir.sol-gel.com/news-releases/news-release-details/sol-gel-technologies-announces-last-patient-last-visit-pivotal
2. Efficacy and safety of patidegib Gel 2% for preventing basal cell carcinomas on the face of adults with gorlin syndrome. ClinicalTrials.gov identifier: NCT06050122. Updated August 2026. Accessed September 17, 2026. https://clinicaltrials.gov/study/NCT06050122

Frequently Asked Questions

What is SGT-610 (patidegib gel, 2%) being studied for?
SGT-610 is an investigational topical hedgehog inhibitor being evaluated for the prevention of new basal cell carcinomas on the face of adults with Gorlin syndrome.

What does last patient last visit mean for the SGT-610-01 trial?
Last patient last visit means all enrolled patients have completed the 12-month treatment and follow-up period; Sol-Gel is now proceeding to database lock and statistical analysis.

When will results from the SGT-610-01 trial be available?
Sol-Gel expects to report top-line results, including the primary end point outcome, in late November 2026.