FDA Accepts Eton Pharmaceuticals’ NDA for Pediatric Diabetes Insipidus Drug

Eton Pharmaceuticals announced that the FDA has accepted its New Drug Application for ET-600, a patented desmopressin oral solution designed to treat central diabetes insipidus in pediatric patients, with a target action date set for February 25, 2026. ET-600 would be the only oral liquid option for this rare condition, addressing a significant unmet need affecting around 3,000 children in the U.S., who currently rely on cutting tablets or unapproved liquid compounding. The company has secured patent protection for ET-600’s formulation extending to 2044 and has already begun commercial preparations for a potential launch in early 2026. Eton Pharmaceuticals has experienced strong revenue growth recently and focuses on developing treatments for rare diseases, with eight commercial products and multiple candidates in late-stage development. The stock reacted positively to the FDA announcement, rising sharply in premarket trading. CEO Sean Brynjelsen emphasized the importance of ET-600 in providing accurate dosing options for pediatric endocrinology patients and described the product launch as a high-value near-term opportunity for the company.