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A pivotal pilot bioequivalence study for ET-600

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Trial Profile

A pivotal pilot bioequivalence study for ET-600

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 15 Jul 2025

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At a glance

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

Most Recent Events

  • 08 Jul 2025 According to an Eton pharmaceuticals media release,U.S. Food and Drug Administration (FDA) has accepted New Drug Application (NDA) for ET-600 for review, and has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of February 25, 2026.
  • 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

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