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Also known as Patidegib Topical Gel, IPI-926, Saridegib, SGT-610
Patidegib · 2 trials · 2 indications
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 |
| 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 | 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. |
| Patidegib Topical Gel, 2% | DRUG | Patidegib Topical Gel, 2% |
| Patidegib Topical Gel, Vehicle | DRUG | Patidegib Topical Gel, Vehicle |
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 treatment being developed for Gorlin syndrome, also called basal cell nevus syndrome. It is intended to reduce the disease burden of basal cell carcinomas that develop persistently in adults with this rare inherited condition, including lesions on the face.
Patidegib is a small molecule antagonist of SMO, a protein in the Hedgehog signaling pathway. By blocking SMO, patidegib is designed to inhibit the aberrant Hedgehog pathway signaling that drives basal cell carcinoma development in Gorlin syndrome. It is formulated as a topical gel applied directly to the skin.
Patidegib is being developed by Sol-Gel Technologies Ltd., which trades under the ticker SLGL. The company is advancing the topical gel formulation for Gorlin syndrome, also known as basal cell nevus syndrome.
Patidegib is in Phase 3 clinical development. It is an investigational therapy and has not been approved by the FDA. Two Phase 3 trials have been completed, and no trials are currently listed as active.
Patidegib has been studied in two completed Phase 3 trials. NCT03703310 enrolled 174 patients with basal cell nevus syndrome, and NCT06050122 enrolled 113 adults with Gorlin syndrome across the United States and several European countries. Both were randomized, double-blind, and placebo-controlled.
Yes. Patidegib topical gel, 2% is the same investigational product as patidegib, referring to the 2% strength gel formulation used in its clinical trials. Patidegib is also written as patidegib, 2% in some references.