ET-600 is involved in a pivotal bioequivalence study. Credit: shisu_ka/Shutterstock.

Eton Pharmaceuticals has secured a patent from the US Patent and Trademark Office (USPTO) for its ET-600 product candidate’s desmopressin oral solution formulation for diabetes insipidus, which affects around one in 25,000 children – almost 3,000 US paediatric subjects annually.

It causes the body to produce an excessive amount of urine, leading to severe dehydration and potentially delayed or stunted growth if untreated.

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The US Patent No 12,214,010, which expires in 2044, is expected to be listed in the Orange Book of the Food and Drug Administration (FDA) following the product’s approval.

An additional patent application related to ET-600 is under review.

Eton Pharmaceuticals CEO Sean Brynjelsen stated: “This patent strengthens our growing intellectual property portfolio and underscores our commitment to delivering innovative treatments to underserved patient populations.

“The paediatric 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 recognised with a patent.”  

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Desmopressin is approved in tablet, nasal and injectable forms, but does not completely meet the paediatric need for precise, titratable [able to determine the smallest concentration required to bring about a given effect] and small doses.

Consequently, paediatric subjects often rely on unapproved liquid suspensions from compounding pharmacies, cut and measure fractional tablets, or resort to daily injections

ET-600 is presently in a pivotal bioequivalence study and passed a similar trial in 2024.

Eton expects the outcomes of the study at the end of February 2025.

It anticipates filing a new drug application with the US regulator by the second quarter of 2025 if outcomes are positive.

Eton’s other product candidates in late-stage development are Zeneo hydrocortisone autoinjector, ET-400 and Amglidia.

In November 2024, the company acquired the US rights to Amglidia, a treatment for neonatal diabetes mellitus, from French biotechnology company AMMTeK.