Sol-Gel Technologies' Drug in the FDA Approval Process
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
Epsolay. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
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.
Read Announcement
Sol-Gel Technologies FDA Events - Frequently Asked Questions
As of now, Sol-Gel Technologies (SLGL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Sol-Gel Technologies (SLGL) has reported FDA regulatory activity for Epsolay (Benzoyl Peroxide).
The most recent FDA-related event for Sol-Gel Technologies occurred on September 4, 2025, involving Epsolay (Benzoyl Peroxide). The update was categorized as "Clinical Trial," with the company reporting: "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."
Currently, Sol-Gel Technologies has one therapy (Epsolay (Benzoyl Peroxide)) targeting the following condition: Inflammatory Lesions of Rosacea.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SLGL) was last updated on 9/6/2025 by MarketBeat.com Staff
Free SLGL Stock Alerts