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Also known as Patidegib Topical Gel
Patidegib · 1 trial · 1 indication
New BCCs at Month 12 in the Patidegib Gel 2% and Vehicle Gel groups, as assessed by the CPRB
| Arm | Type | Description |
|---|---|---|
| Patidegib Gel 2% | EXPERIMENTAL | Patidegib Gel 2% (w/w), applied topically to the face twice daily for 12 months |
| Vehicle Gel | PLACEBO_COMPARATOR | Vehicle Gel, applied topically to the face twice daily for 12 months |
| Name | Type | Description |
|---|---|---|
| Patidegib Topical Gel | DRUG | Patidegib Gel 2% is a smooth, clear, colorless-to-yellow, viscous, hydro-alcoholic gel for topical administration. |
| Patidegib Topical Gel with no active patidegib | DRUG | Vehicle Gel consists of the excipients of Patidegib Gel with no active patidegib. It is a smooth viscous gel for topical administration. |
Key Inclusion Criteria: 1. The subject must be at least 18 years old at the Screening Visit. 2. The subject must be confirmed to have a PTCH1 mutation. 3. The subject must have at least 10 BCCs on the face at Randomization (Baseline/Day 1). 4. The subject must be willing to abstain from application...
Patidegib is an investigational topical gel being studied for the treatment of Basal Cell Nevus Syndrome, also known as Gorlin Syndrome, a rare genetic condition characterized by the development of numerous basal cell carcinomas. It is intended to reduce the disease burden of persistently developing basal cell carcinomas in affected adults.
Patidegib targets the Hedgehog signaling pathway, as indicated by its classification as a -degib (Hedgehog) inhibitor. By modulating this pathway, the drug aims to address the underlying mechanism driving basal cell carcinoma formation in patients with Gorlin Syndrome.
Patidegib is being developed by Sol-Gel Technologies Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SLGL. The company is conducting clinical trials to evaluate the safety and efficacy of this topical gel formulation for Gorlin Syndrome.
Patidegib is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been conducted or are ongoing to assess its effectiveness in reducing basal cell carcinoma burden in patients with Gorlin Syndrome.
Patidegib has been evaluated in two Phase 3 clinical trials. The first, NCT03703310, was a completed study with 174 participants investigating the gel's effect on disease burden in Basal Cell Nevus Syndrome. The second, NCT06050122, is an active but not recruiting trial with 140 participants focusing on preventing facial basal cell carcinomas in Gorlin Syndrome.
Yes, Patidegib and Patidegib Topical Gel refer to the same drug product. The topical gel formulation is the specific dosage form being studied in clinical trials for the treatment of Gorlin Syndrome, and both names are used interchangeably in research contexts.