Eton Pharmaceuticals Announces Positive Pivotal Clinical Study Results for Product Candidate ET-600
Eton Pharmaceuticals, Inc recently 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 U.S. 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 pediatric endocrinology community, we’ve come to appreciate the significant need for a desmopressin medication that can accommodate the precise and titratable doses necessary for pediatric 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.
About ET-600
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 pediatric patients in the United States.
About Eton Pharmaceuticals
Eton is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases. The Company currently has seven commercial rare disease products: INCRELEX®, ALKINDI SPRINKLE®, GALZIN®, PKU GOLIKE®, Carglumic Acid, Betaine Anhydrous, and Nitisinone. The Company has four additional product candidates in late-stage development: ET-400, ET-600, Amglidia®, and ZENEO® hydrocortisone autoinjector. For more information, please visit our website at www.etonpharma.com.
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