NDAORALTABLET
Approved
Apr 2022
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
3
Data completeness
5/8 — Partial
Drug data last refreshed 17h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CUVRIOR (trientine tetrahydrochloride) is an oral small-molecule tablet approved in April 2022 for the treatment of Wilson's disease, a rare genetic disorder of copper metabolism. The drug functions as a copper chelator, binding and facilitating urinary excretion of excess copper in affected patients. It represents an established therapeutic option in a narrow, well-defined orphan disease population.
$0.378MPart D
Peak12.5 years to LOEProduct is in peak lifecycle stage with minimal part D penetration, indicating a niche orphan market with limited team expansion opportunities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (3)
Trientine Tetrahydrochloride Administered Once a Day for the First Line Treatment of Wilson's Disease Patients.
Started Sep 2026
38 enrolled
Wilson's Disease
Patient Preference Study: Standard of Care Versus Once-daily Trientine Tetrahydrochloride
Started Jul 2025
10 enrolled
Wilson's Disease
Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease
Started Sep 2018
77 enrolled
Wilson Disease
Career Relevance
Working on CUVRIOR places you in a specialized rare-disease commercial environment with a very small team footprint (1 linked job) and heavy emphasis on regulatory compliance and quality documentation. This role is ideal for professionals seeking deep expertise in orphan drug operations, regulatory affairs, and niche market dynamics rather than broad commercial scaling.
Worked on CUVRIOR at Orphalan? 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.