Clinical Trial to Confirm the Efficacy and Safety of Zinc Acetate Granules 5% Sawai in Patients with Wilson’s Disease

Abstract

We conducted an open-label, multicenter clinical trial to evaluate the efficacy and safety of switching from the original drug (NOBELZIN^® Tablets 25 mg/50 mg) to a generic drug (Zinc Acetate Granules 5% Sawai) in patients with Wilson’s disease. The primary endpoint was treatment effectiveness, assessed through alanine aminotransferase (ALT) levels. Secondary endpoints included clinical symptoms such as hepatomegaly, ascites, edema, and neurologic symptoms. Laboratory parameters were also evaluated, which included aspartate aminotransferase (AST), γ- glutamyltransferase (γ-GT), alkaline phosphatase (ALP), serum copper concentration, serum ceruloplasmin level, serum ceruloplasmin-unbound copper (free copper) level, and spot urine copper excretion. The switch from the original to the generic drug did not result in clinically meaningful changes in these endpoints. No significant differences were observed in laboratory tests or vital signs, and adverse events were both mild and within the clinically acceptable range. These findings indicate that the generic drug is as effective and safe as the original drug for individuals with Wilson’s disease.