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pp-097

Gel

Dossier type
CTD
Dossier status
Under development
Country of origin
Israel
Comments
Indication: Prevention of new basal cell carcinoma (BCC) lesions in adults with Gorlin syndrome, a rare genetic condition with high propensity for BCC formation Clinical stage: Late clinical development — Phase 3 global clinical trial underway with top‑line results anticipated in late 2026 Modality: Small molecule, topical gel formulation Mechanism / Target: Hedgehog signaling pathway blocker targeting the SMO receptor to reduce aberrant pathway activity driving BCC lesion formation Route / form: Topical administration; 2% gel formulation intended for chronic use on the skin Differentiation: First‑in‑class topical hedgehog pathway inhibitor designed specifically for BCC prevention with minimal systemic adverse effects compared with oral hedgehog inhibitors
Manufacturer #38928

Clinical-stage biotechnology company developing targeted topical therapies for rare dermatologic conditions. Focuses on hedgehog pathway inhibitors to prevent basal cell carcinoma lesions. Strategy emphasizes global clinical trials and future commercialization partnerships.

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