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
Price :
$35
*
At a glance
- Drugs Mercaptamine (Primary)
- Indications Nephropathic cystinosis
- Focus Registrational; Therapeutic Use
- Acronyms Cystadrops09choc-study
- Sponsors Orphan Europe
- 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