Trial Profile

A pivotal pilot bioequivalence study for ET-600

Status: Recruiting

Phase of Trial: Phase III

Latest Information Update: 05 May 2025

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At a glance

Drugs Desmopressin (Primary)
Indications Diabetes insipidus
Focus Pharmacokinetics; Registrational
Sponsors Eton Pharmaceuticals

Most Recent Events

28 Apr 2025 According to an Eton pharmaceuticals media release, the company announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ET-600 for the treatment of central diabetes insipidus. The company expects the application to be assigned a 10-month FDA review, allowing for potential approval and launch in the first quarter of 2026.
18 Mar 2025 According to an Eton pharmaceuticals media release, Company preparing for an April 2025 NDA submission
14 Mar 2025 Results presented in the Eton pharmaceuticals Media Release.

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