Eton Pharmaceuticals Submits NDA for ET-600 (Desmopressin Oral Solution)

DEER PARK, Ill., April 28, 2025 – Eton Pharmaceuticals, Inc., a pioneering company in the pharmaceutical industry dedicated to the development and commercialization of treatments for rare diseases, has recently announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). This application is for ET-600, a proprietary and patented oral solution of desmopressin, which Eton has developed for the treatment of central diabetes insipidus.

The NDA process is expected to undergo a 10-month review by the FDA, potentially culminating in approval and introduction to the market in the first quarter of 2026. This development marks a significant milestone for Eton Pharmaceuticals and offers hope to the pediatric population affected by diabetes insipidus. If approved, ET-600 will stand as the sole FDA-approved oral liquid formulation of desmopressin, tailored to deliver the small, precise, and adjustable doses essential for treating young patients. According to Sean Brynjelsen, Eton Pharmaceuticals CEO, leading pediatric endocrinologists have consistently highlighted the necessity of such a product, reinforcing the company's commitment to addressing this unmet need.

Patents have been granted for ET-600 by the U.S. Patent and Trademark Office, securing its exclusivity until 2044. Additionally, there are further patent applications currently under review. In a study involving 75 human subjects, ET-600 demonstrated pharmacokinetic equivalence to the FDA-approved reference product containing the same active ingredient. Eton Pharmaceuticals estimates that central diabetes insipidus affects around 3,000 children in the United States, underscoring the potential impact of ET-600 upon its approval and release.

As preparations for the potential launch of ET-600 in the first quarter of 2026 are underway, Eton Pharmaceuticals is also engaged in several other innovative projects. The company boasts a portfolio of seven commercial products focusing on rare diseases, including INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. Furthermore, the company has six additional product candidates in advanced stages of development, such as ET-400, ET-700, ET-800, Amglidia®, and the ZENEO® hydrocortisone autoinjector.

Eton Pharmaceuticals continues to solidify its position as a leader in the pharmaceutical industry, with a clear focus on bridging the gap in treatments for rare diseases. Their ongoing efforts not only aim to bring ET-600 to market but also to advance the development of other innovative therapies that can make a significant difference in the lives of patients with rare conditions.