CYSTAGON

LOE Approaching

cysteamine bitartrate

NDAORALCAPSULEPriority Review
Approved
Aug 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6

Mechanism of Action

Mechanism of Action Cystinosis is an autosomal recessive inborn error of metabolism in which the transport of cystine out of lysosomes is abnormal; in the nephropathic form, accumulation of cystine and formation of crystals damage various organs, especially the kidney, leading to renal tubular…

Clinical Trials (5)

NCT02473445Phase 2Terminated

A Long-term Extension of Study RP103-MITO-001 (NCT02023866) to Assess Cysteamine Bitartrate Delayed-release Capsules (RP103) in Children With Inherited Mitochondrial Disease

Started May 2015
22 enrolled
Mitochondrial Diseases
NCT01733316Phase 3Completed

Open-Label, Safety and Superior Effectiveness Study of Cysteamine Bitartrate Delayed-Release Capsules (RP103) in Cystinosis

Started Jan 2013
41 enrolled
Cystinosis
NCT01744782Phase 3Completed

Safety/Effectiveness Study of Cysteamine Bitartrate Delayed-release Capsules (RP103) in Cysteamine Treatment Naive Patients With Cystinosis

Started Dec 2012
17 enrolled
Cystinosis
NCT01197378Phase 3Completed

Long-Term Safety Follow-up Study of Cysteamine Bitartrate Delayed-release Capsules (RP103)

Started Aug 2010
60 enrolled
Cystinosis
NCT01000961Phase 3Completed

Phase 3 Study of Cysteamine Bitartrate Delayed-release (RP103) Compared to Cystagon® in Patients With Cystinosis

Started Jun 2010
43 enrolled
Cystinosis