NDAOPHTHALMICSOLUTION/DROPSPriority Review
Approved
Oct 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
6/8 — Strong
Priority Review
CYSTARAN (cysteamine hydrochloride) by Leadiant Biosciences is cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation. Approved for cystinosis. First approved in 2012.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYSTARAN is a cysteamine hydrochloride ophthalmic solution approved in 2012 for cystinosis, a rare lysosomal storage disorder. It works as a cystine-depleting agent by converting cystine to cysteine and mixed disulfides, reducing corneal cystine crystal accumulation and associated photophobia. The drug addresses ocular manifestations of this life-threatening genetic condition.
$0.002BPart D
PeakStable
Niche peak-stage product with modest spending ($2M) reflecting small patient population; limited team expansion expected.
Mechanism of Action
cystine-depleting agent by converting cystine to cysteine and cysteine-cysteamine mixed disulfides and reduces corneal cystine crystal accumulation.
Indications (1)
Clinical Trials (1)
Randomized Study of New Formulation Ophthalmic Cysteamine Hydrochloride for Corneal Cystine Accumulation in Patients With Cystinosis
Started Dec 1999
30 enrolled
Cystinosis
Career Relevance
CYSTARAN is a niche orphan product with limited linked job postings, reflecting its modest $2M market size and small cystinosis patient population. Career roles focus on patient identification, narrow-network reimbursement, and rare-disease specialist engagement rather than broad commercial scaling.
Worked on CYSTARAN at Leadiant Biosciences? Share your interview experience or compensation data (+7 days Pro)
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.