GALZIN
LOE Approachingzinc acetate
NDAORALCAPSULE
Approved
Jan 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
GALZIN (zinc acetate) is clinical pharmacology introduction wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile, resulting in accumulation of excess copper in the liver, and subsequently in other organs, including the brain, kidneys, eyes, bone, and muscles. First approved in 1997.
Drug data last refreshed 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
GALZIN (zinc acetate) is an oral small-molecule copper chelator approved for Wilson's disease, a rare autosomal recessive metabolic disorder causing toxic copper accumulation in the liver and brain. It works by inducing metallothionein production in intestinal cells, which binds dietary and endogenously secreted copper, preventing absorption and promoting fecal excretion. The drug is used for both initial detoxification and long-term maintenance therapy in symptomatic patients.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling a contraction phase that will likely reduce commercial team headcount and shift focus to cost management and generic transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Introduction Wilson's disease (hepatolenticular degeneration) is an autosomal recessive metabolic defect in hepatic excretion of copper in the bile, resulting in accumulation of excess copper in the liver, and subsequently in other organs, including the brain, kidneys, eyes,…
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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