Eton Pharma Reports Positive ET-600 Bioequivalence Study Results

Eton Pharmaceuticals, Inc (Eton), an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases, announced positive results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for the treatment of central diabetes insipidus.

In a bioequivalence study conducted in 75 human subjects, ET-600 demonstrated pharmacokinetic equivalence to the US Food and Drug Administration (FDA)-approved reference product of the same active ingredient. Healthy adults enrolled in the study were randomly assigned to receive the test and reference drug in an open label, balanced, randomized, single-dose, three-treatment, three-sequence, three-period, three-way crossover oral bioequivalence study. Based on these successful trial results, Eton anticipates submitting an NDA to the FDA for ET-600 in April 2025. If approved, ET-600 would be the only FDA-approved oral liquid formulation of desmopressin.

“We are pleased to see ET-600 pass its pivotal study and move one step closer to reaching patients. Through our deep relationships in the paediatric endocrinology community, we've come to appreciate the significant need for a desmopressin medication that can accommodate the precise and titratable doses necessary for paediatric patients. We expect to submit the NDA shortly and have begun pre-launch commercial readiness activities in anticipation of a potential launch in the first quarter of 2026,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals.

ET-600 is a proprietary formulation of desmopressin oral solution developed for the treatment of central diabetes insipidus. The company has been issued a patent for ET-600’s formulation that extends to 2044 and has an additional patent application under revise by the United States Patent and Trademark Office. Central diabetes insipidus is estimated to impact approximately 3,000 paediatric patients in the United States.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!