Eton Pharma Plans FDA Filing For ET-600 Oral Desmopressin Next Month, Eyes 2026 Launch

On Friday, Eton Pharmaceuticals, Inc ETON revealed results from its bioequivalence study of ET-600, a proprietary, patented oral solution of desmopressin under development for central diabetes insipidus.

Central diabetes insipidus (CDI), or arginine vasopressin deficiency, is a condition where the body doesn’t produce enough antidiuretic hormone (ADH) or vasopressin, leading to excessive urination and thirst.

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.

Eton anticipates submitting a marketing application 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 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.

In February, Eton Pharmaceuticals announced that the FDA extended the Prescription Drug User Fee Act (PDUFA) goal date for the New Drug Application (NDA) for ET-400. The new PDUFA goal date is May 28, 2025.

The company was notified that the FDA requires additional time to conduct a full review of supplemental information provided in December in response to an FDA request.

In February, the United States Patent and Trademark Office granted the company U.S. Patent No. 12,214,010, covering its ET-600 product candidate’s proprietary formulation of desmopressin oral solution. The patent expires in 2044.

ET-600 previously passed a pilot bioequivalence study in 2024.

In January, Eton Pharmaceuticals acquired Galzin (zinc acetate).

Galzin is FDA-approved as a maintenance treatment of patients with Wilson Disease who have been initially treated with a chelating agent.

Price Action: ETON stock is up 4.62% at $15.28 at the last check Friday.

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