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Cysteamine Hydrochloride for nephropathic Cystinosis, open-label Phase III pivotal study

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Trial Profile

Cysteamine Hydrochloride for nephropathic Cystinosis, open-label Phase III pivotal study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 27 Aug 2020

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At a glance

  • Drugs Mercaptamine (Primary)
  • Indications Nephropathic cystinosis
  • Focus Registrational; Therapeutic Use
  • Acronyms Cystadrops09choc-study
  • Sponsors Orphan Europe

Most Recent Events

  • 25 Aug 2020 According a Recordati Rare Diseases media release, based on the data from a Phase I/II trial a Phase III trial, the U.S. Food and Drug Administration (FDA) has approved CYSTADROPS (cysteamine ophthalmic solution) 0.37% in people living with cystinosis.
  • 07 Jul 2015 New trial record

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