Eton Pharmaceuticals gains U.S. patent for innovative diabetes insipidus treatment

USA – Eton Pharmaceuticals has received a U.S. patent for ET-600, an oral desmopressin solution developed to treat diabetes insipidus (DI).

This rare condition, affecting about 1 in 25,000 children in the U.S., leads to excessive urine production, dehydration, and potential growth issues if left untreated.

While desmopressin is available in tablet, nasal, and injectable forms, these options do not always provide the precise, adjustable dosing required for pediatric patients. ET-600 aims to address this gap by offering a more effective liquid formulation.

The newly granted U.S. Patent No. 12,214,010 is set to expire in 2044 and is expected to be listed in the FDA’s Orange Book after the product receives approval. Additionally, another patent application related to ET-600 is currently under review.

Eton Pharmaceuticals CEO Sean Brynjelsen emphasized the importance of this patent, stating, “This patent strengthens our growing intellectual property portfolio and underscores our commitment to delivering innovative treatments to underserved patient populations.

“The pediatric endocrinology community has expressed the significant need for a liquid form of desmopressin that can accurately and efficiently deliver small doses for children, and we are proud to have developed a formulation to meet their needs and to see our innovation recognized with a patent.”

Currently, children with DI often rely on unapproved liquid suspensions from compounding pharmacies, split tablets to approximate doses, or resort to daily injections.

ET-600, now in a pivotal bioequivalence study, successfully passed a similar trial in 2024. Eton expects study results by the end of February 2025 and plans to submit a new drug application to the FDA in the second quarter of 2025 if the outcomes are positive.

Beyond ET-600, Eton Pharmaceuticals has other late-stage product candidates, including the Zeneo hydrocortisone autoinjector, ET-400, and Amglidia.

In November 2024, Eton acquired the U.S. rights to Amglidia, a neonatal diabetes mellitus treatment, from French biotech company AMMTeK.

Meanwhile, in the broader diabetes insipidus treatment space, NephroDI Therapeutics is advancing NDI-5001, an oral small molecule designed to treat congenital nephrogenic diabetes insipidus (NDI), a rare pediatric condition.

This drug functions as an AMPK activator, improving kidney function to help concentrate urine.

Recent funding from Sound Bioventures is expected to accelerate NDI-5001’s development, highlighting ongoing industry efforts to advance DI treatments.