Galzin provides maintenance therapy for a lifelong disease1,2

Recommended First-Line Maintenance Therapy

The American Association for the Study of Liver Diseases (AASLD) recommends zinc as a first-line maintenance therapy for all patients with Wilson disease, including3

  • Patients who have completed initial chelation therapy
  • Patients who are asymptomatic

Galzin effectively inhibits the absorption of copper so your patients with Wilson disease can focus less on treatment and more on living1

In a pharmacodynamic study of 60 patients with Wilson disease

  • 91% of copper balance tests (N=70) showed adequate control with the recommended dose of 50 mg of Galzin 3 times daily
  • 25 mg 3 times daily was also thought to be an adequate dose regimen and not shown to be inferior to 50 mg 3 times daily based on the limited data available

In pharmacodynamic studies, a 50 mg 3 times daily regimen of Galzin consistently induced a negative mean copper balance (−0.44 mg/day) and an adequate mean radiolabeled 64Cu uptake (0.82% of the administered Galzin dose).

In a retrospective study* comparing zinc acetate to other dietary supplements, the target range for urinary copper excretion was reached in4

  • 81% of patients on zinc acetate
  • 73% of patients on zinc gluconate
  • 57% of patients on alternative zinc

*For information only, clinical applicability is undetermined. Patients may or may not have been on Galzin.

Urinary copper excretion (µg/24 hours) was categorized as low <25 µg, target range 25-100 µg, or elevated >100 µg.

Galzin is the only FDA-approved zinc for Wilson disease and offers what dietary supplements may not4,5

FDA-approved for 25+ years2

Rigorous drug cGMP manufacturing standards5

Consistent, accurate dosing1

Clinically demonstrated efficacy1,2

Decades of demonstrated safety and tolerability1,2

Gastric irritation (gastritis) is the most commonly reported side effect of Galzin and is often worst with the first morning dose. For most patients, this discomfort goes away within the first few days of therapy.

INDICATION AND IMPORTANT SAFETY INFORMATION

INDICATION

Galzin® (zinc acetate) is indicated for maintenance treatment of patients with Wilson’s disease who have been initially treated with a chelating agent.

IMPORTANT SAFETY INFORMATION

Contraindication

Hypersensitivity to zinc acetate or any of the ingredients in Galzin.

Warnings and Precautions

Copper Deficiency: Several post-marketing cases reported that zinc acetate taken over extended periods of time may result in decreased enteral copper absorption and copper deficiency. If a patient develops signs and/or symptoms of copper deficiency, interrupt zinc treatment and measure zinc, 24-hr urinary copper, and non-ceruloplasmin bound copper (NCC) levels.

Gastric Ulcer: Gastric ulcers including complications of anemia and gastric ulcer perforation with peritonitis have been reported with long-term use of zinc acetate.

General: Galzin is not recommended for the initial therapy of symptomatic patients because of the delay required for zinc-induced increase in enterocytic metallothionein and blockade of copper uptake. Symptomatic patients should be treated initially using chelating agents. During initial therapy, neurological deterioration may occur as stores of copper are mobilized.

Information for Patients: GALZIN should be administered on an empty stomach, at least one hour before or two to three hours after meals. Capsules should be swallowed whole, not opened or chewed. Patients must be clinically monitored to determine the adequacy of zinc acetate therapy.

Monitoring Patients: Existing signs and symptoms of Wilson’s disease and 24-hour urine copper should be monitored. Neuropsychiatric evaluations including speech as well as liver function tests including bilirubin and aminotransferases, should be done as appropriate. In all treated patients, 24--hour urinary zinc levels may be a useful measure of compliance with the zinc acetate regimen.

Adverse Reactions

The most common adverse reactions are gastric irritation, elevations of serum alkaline phosphatase, amylase, and lipase suggesting pancreatitis.

To report a suspected adverse event related to GALZIN, contact Eton Pharmaceuticals, Inc. at 1-855-224-0233 or the U.S. Food and Drug Administration (FDA) at www.fda.gov/safety/Medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.

References: 1. Galzin (zinc acetate) capsules. Prescribing information. Eton Pharmaceuticals; 2025. 2. Brewer GJ. Zinc acetate for the treatment of Wilson disease. Expert Opin Pharmacother. 2001;2(9):1473-1477. 3. Schilsky ML, Roberts EA, Bronstein JM, et al. A multidisciplinary approach to the diagnosis and management of Wilson disease: 2022 Practice Guidance on Wilson disease from the American Association for the Study of Liver Diseases. Hepatology. Published online December 7, 2022. doi:10.1002/hep.32801. 4. Camarata MA, Ala A, Schilsky ML. Zinc maintenance therapy for Wilson Disease: a comparison between zinc acetate and alternative zinc preparations. Hepatol Commun. 2019;3(8):1151-1158. 5. LeDoux MS. Zinc gluconate for Wilson disease. Clin Park Relat Disord. 2024;11:100272.