FDA accepts NDA for ET-600, desmopressin oral solution for pediatric AVP deficiency

FDA accepts NDA for ET-600, desmopressin oral solution for pediatric AVP deficiency | © Contemporary Pediatrics

The FDA has accepted the New Drug Application (NDA) for ET-600, a proprietary oral formulation of desmopressin developed by Eton Pharmaceuticals, Inc. The NDA has been assigned a Prescription Drug User Fee Act target action date of February 25, 2026.

ET-600 is intended for the treatment of central diabetes insipidus, also referred to as arginine vasopressin deficiency (AVP-D), in pediatric patients. The proposed oral solution formulation is designed to address challenges in dosing accuracy associated with current treatment options.

“We are thrilled to be one step closer to bringing ET-600 to patients and addressing another significant unmet need within the pediatric endocrinology community,” said Sean Brynjelsen, CEO of Eton Pharmaceuticals. “Currently, caregivers are often forced to cut fractional tablets or use unapproved liquid suspensions from compounding pharmacies to accommodate the precise, titratable doses required to treat pediatric patients. If approved, ET-600 is expected to be the only oral liquid option on the market, providing a much-needed avenue for delivering accurate doses for children.”

AVP-D affects an estimated 3,000 pediatric patients in the United States. Treatment requires careful titration to manage symptoms and avoid complications related to water balance and electrolyte levels. ET-600 is designed to facilitate more precise and consistent dosing in pediatric populations, where current therapies often present practical limitations.

Eton Pharmaceuticals has been granted a US patent for the ET-600 formulation, which extends through 2044. An additional patent application for the product is under review by the US Patent and Trademark Office.

“ET-600 represents yet another high-value near term product launch opportunity for Eton and our team has already initiated commercial preparation activities in anticipation of a potential launch in the first quarter of 2026,” Brynjelsen said.

If approved, ET-600 would be the only FDA-approved oral liquid desmopressin product available for pediatric patients with AVP-D.

Reference:

Eton Pharmaceuticals. Eton Pharmaceuticals Announces FDA Acceptance of New Drug Application for ET-600 (Desmopressin Oral Solution). Global Newswire. July 8, 2025. Accessed July 8, 2025. https://www.globenewswire.com/news-release/2025/07/08/3111576/0/en/Eton-Pharmaceuticals-Announces-FDA-Acceptance-of-New-Drug-Application-for-ET-600-Desmopressin-Oral-Solution.html