Itraconazole
Search documents
Inhibitor Therapeutics Provides Clinical, Formulation and IP Update on Itraconazole Program for Gorlin Syndrome
Globenewswire· 2026-03-31 19:44
Core Viewpoint - Inhibitor Therapeutics, Inc. is advancing its pharmacokinetic clinical program for treating basal cell carcinomas in patients with Basal Cell Carcinoma Nevus Syndrome and plans to file a new global patent application for its proprietary itraconazole formulation [1][6]. Group 1: Clinical Development - The comparative pharmacokinetic, safety, and tolerability study is being conducted in healthy adults in Malaysia as a three-way crossover study against a reference drug, in collaboration with Avior Bio, Inc. [2] - The study is progressing through its dosing periods, with Period 2 on April 10, 2026, and Period 3 on April 24, 2026, with top-line results expected before the full Clinical Study Report [3]. - This pharmacokinetic study is anticipated to be the final clinical study required before submitting a New Drug Application to the FDA for the BCCNS program [3]. Group 2: Formulation Strategy - The company employs a proprietary amorphous formulation approach for itraconazole, addressing solubility limitations of the conventional crystalline form, which can lead to variability in absorption [4]. - The Investigational Medicinal Product Dossier supports the formulation strategy, showing the product candidate as amorphous and developed to improve intestinal solubility and absorption [5]. Group 3: Intellectual Property - Inhibitor is preparing a new patent application for its proprietary formulation, which, if granted, would enhance its intellectual property estate and strategic value for the BCCNS program [6]. Group 4: Market Context - Gorlin Syndrome is a rare hereditary disorder leading to multiple basal cell carcinomas, and Inhibitor's itraconazole aims to meet the significant unmet medical need for patients facing repeated surgeries [7]. Group 5: Company Overview - Inhibitor Therapeutics, Inc. is a clinical-stage pharmaceutical company focused on developing innovative therapies using repurposed, approved active pharmaceutical ingredients, with its lead program targeting surgically eligible basal cell carcinomas in BCCNS [8].