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Also known as Patidegib Topical Gel, Patidegib
Patidegib, 2% · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Patidegib Topical Gel, 2%, | EXPERIMENTAL | Participants will be randomized to receive Patidegib Topical Gel, 2%. The Patidegib Topical Gel, 2% will be dispensed to participants at each study visit and applied topically twice daily to the face. |
| Patidegib Topical Gel, Vehicle | PLACEBO_COMPARATOR | Participants will be randomized to receive Vehicle. The Patidegib Topical Gel, Vehicle will be dispensed to participants at each study visit and applied topically twice daily to the face. |
| Name | Type | Description |
|---|---|---|
| Patidegib Topical Gel, 2% | DRUG | Patidegib Topical Gel, 2% |
| Patidegib Topical Gel, Vehicle | DRUG | Patidegib Topical Gel, Vehicle |
Inclusion Criteria: 1. The participant must be age at least 18 years of age at the Screening Visit. 2. The participant must provide written informed consent prior to any study procedures. 3. The participant must meet diagnostic criteria for the basal cell nevus (Gorlin) syndrome including major cri...
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.