Sebela Pharmaceuticals has entered an exclusive partnership with HK inno.N Corporation to license tegoprazan in the United States and Canada. Under the agreement, Braintree Laboratories, a leader in gastroenterology and an affiliate of Sebela Pharmaceuticals, will be responsible for clinical development, registration, marketing, and sales in the United States and Canada. Tegoprazan, a novel potassium-competitive acid-blocker (P-CAB), is currently approved and marketed in several territories, including South Korea and China.

Following successful discussions with the US Food and Drug Administration, Sebela Pharmaceuticals has initiated Phase 3 studies of tegoprazan in patients with gastroesophageal reflux disease (GERD). The Phase 3 GERD program, known as the TRIUMpH program, includes a large, multi-center, double-blind study evaluating the safety and efficacy of tegoprazan versus a PPI control for the indications of healing of all grades of erosive esophagitis (EE) and the maintenance of EE healing and relief of heartburn. The TRIUMpH program also includes a large, multicenter, double-blind, placebo-controlled study designed to demonstrate the safety and efficacy of tegoprazan in patients with non-erosive reflux disease (NERD).