An Open-Label, Safety and Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naïve Patients With Cystinosis
Phase of Trial: Phase III
Latest Information Update: 19 Jan 2018
At a glance
- Drugs Mercaptamine bitartrate (Primary)
- Indications Cystinosis
- Focus Pharmacodynamics; Registrational
- Sponsors Horizon Pharma USA; Raptor Pharmaceutical Inc
- 27 Dec 2017 According to a Horizon Pharma media release, based on the results of this trial, the US FDA has approved an expansion to the indication for PROCYSBI (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis.
- 27 Dec 2017 Results presented in a Horizon Pharma media release.
- 13 Feb 2017 Status changed from active, no longer recruiting to completed.