This section highlights FDA-related milestones and regulatory updates for drugs developed by Sol-Gel Technologies (SLGL).
Over the past two years, Sol-Gel Technologies has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SGT-210 and Epsolay. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
SGT-210 FDA Regulatory Events
SGT-210 is a drug developed by Sol-Gel Technologies for the following indication: Darier Disease.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SGT-210
- Announced Date:
- December 17, 2025
- Indication:
- Darier Disease
Announcement
Sol-Gel Technologies, today provided an update following the unblinding of clinical data from its vehicle-controlled proof-of-concept Phase 1b study of SGT-210 on Darier disease.
AI Summary
Sol-Gel Technologies reported that after unblinding the vehicle-controlled proof-of-concept Phase 1b study of SGT-210 in Darier disease, the clinical data did not show differentiation between SGT-210 and the vehicle on the study’s efficacy assessments. The company said the trial did not demonstrate a signal of superiority for the active treatment, and it has decided not to advance SGT-210 to the next stage of development for this indication.
Instead, Sol-Gel plans to pursue very small, low-cost feasibility studies in other rare skin conditions where the drug’s mechanism makes strong scientific sense. The company also said it will prioritize resources toward completing the Phase 3 program for SGT-610 in Gorlin syndrome and preparatory work for a possible Phase 3 in high-frequency basal cell carcinoma, contingent on successful results in the Gorlin trial.
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Epsolay (Benzoyl Peroxide) FDA Regulatory Events
Epsolay (Benzoyl Peroxide) is a drug developed by Sol-Gel Technologies for the following indication: Inflammatory Lesions of Rosacea.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Epsolay (Benzoyl Peroxide)
- Announced Date:
- September 4, 2025
- Indication:
- Inflammatory Lesions of Rosacea
Announcement
Sol-Gel Technologies, conducting a Phase-3 clinical trial of SGT-610 (patidegib gel, 2%) for Gorlin syndrome, a Phase-1b, double blinded clinical trial of SGT-210 (erlotinib ointment, 5%) on Darier disease patients and with two approved large-category dermatology products, TWYNEO and EPSOLAY, announced today that on August 27, 2025 Health Canada issued a Notice of Compliance (NOC) for EPSOLAY for the treatment of inflammatory lesions of rosacea in adults.
AI Summary
Sol-Gel Technologies is conducting a Phase-3 trial of SGT-610 (patidegib gel, 2%) to prevent basal cell carcinomas in patients with Gorlin syndrome. They are also running a Phase-1b, double-blind study of SGT-210 (erlotinib ointment, 5%) in Darier disease. These trials aim to bring new topical treatments to patients with severe skin conditions.
The company markets two large-category dermatology products, TWYNEO (tretinoin and benzoyl peroxide) and EPSOLAY (benzoyl peroxide gel). On August 27, 2025, Health Canada granted a Notice of Compliance for EPSOLAY to treat inflammatory rosacea lesions in adults. Through its licensee Searchlight Pharma, Sol-Gel will receive milestone payments and royalties as EPSOLAY launches in Canada, strengthening its financial position and supporting its growth strategy.
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