NDAORALCAPSULEPriority Review
Approved
Aug 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
6/8 — Strong
Priority Review
CYSTAGON (cysteamine bitartrate) by Viatris (2) is 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 fanconi syndrome and progressive glomerular failure, with end stage renal failure by the end of the first decade of life. Approved for cystinosis, nephropathic cystinosis. First approved in 1994.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTAGON (cysteamine bitartrate) is an oral aminothiol approved in 1994 for nephropathic cystinosis, a rare autosomal recessive lysosomal storage disorder. It works by participating in thiol-disulfide interchange reactions within lysosomes to convert cystine into cysteine and cysteine-cysteamine mixed disulfide, both of which can exit the lysosome and prevent organ damage. Without treatment, cystinosis patients face renal failure by age 10 and multi-organ complications including corneal photophobia, growth failure, and neurological decline.
$0.075MPart D
LOE ApproachingStable
This legacy product faces approaching loss of exclusivity with minimal Part D volume (141 claims), signaling a small, specialized team focused on retention of a niche orphan indication.
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…
Indications (2)
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.