Inhibitor Therapeutics Inc (OTCQB: INTI) is a clinical-stage biopharmaceutical company developing itraconazole as a treatment for basal cell carcinoma nevus syndrome (BCCNS), a rare genetic disorder also known as Gorlin Syndrome. The company generates no product revenue, having no FDA-approved products as of the 10-K filed March 26, 2026. Its strategy centers on advancing itraconazole through regulatory development via a 505(b)(2) NDA pathway, supported by an orphan-drug designation that carries potential for seven years of market exclusivity upon approval. INTI holds an estimated U.S. target population of approximately 11,000 BCCNS patients. The company is actively pursuing strategic transactions, including licensing, co-development, or divestment of the program, with potential consideration structured as upfront payments, development milestones, regulatory milestones, and royalties. As of the filing date, INTI employed two full-time and six part-time employees. The company was originally founded in Virginia in 1992 as Commonwealth Biotechnologies, Inc., emerged from bankruptcy in 2011, and subsequently repositioned as a drug development company. Common stock trades on the OTCQB market under the symbol INTI.
Lead asset: itraconazole, a repurposed antifungal drug being developed for BCCNS (Gorlin Syndrome) under a 505(b)(2) NDA regulatory pathway. A novel formulation is under development by Avior Bio, Inc., with a pharmacokinetic crossover study underway as of the filing date. The company holds orphan-drug designation for itraconazole in BCCNS. Regulatory consulting services are provided by Frameshift Management, Inc. under a performance-based agreement entered in October 2025.
No product revenue as of the 10-K filed March 26, 2026. The company's intended monetization path is through strategic transactions, including regional or global licensing, co-development arrangements, or divestment of the BCCNS program, with deal structures potentially including upfront payments, development and regulatory milestones, and royalties on future net sales.
Target end market is BCCNS (Gorlin Syndrome) patients, with an estimated U.S. population of approximately 11,000 patients. The condition is characterized as a chronic specialty dermatology and oncology indication. No commercial customers exist as of the filing date.
United States. The 10-K filed March 26, 2026 references U.S. regulatory strategy and U.S. patient population estimates. International licensing is cited as a potential strategic transaction avenue but no geographic revenue is reported.
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