USFDA13 Jan 2026, 10:06 am
Sentynl Therapeutics Inc. Receives FDA Approval for ZYCUBO® (copper histidinate) to Treat Menkes Disease
AI Summary
Sentynl Therapeutics Inc., a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences Limited, announced that the U.S. Food and Drug Administration has approved ZYCUBO® (copper histidinate) for the treatment of Menkes disease in pediatric patients. This is the first and only treatment approved for Menkes disease, a rare and fatal genetic condition, in the United States. The approval is supported by positive topline clinical efficacy results, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment with ZYCUBO.
Key Highlights
- ZYCUBO® is the first and only therapy approved for the treatment of Menkes disease in the United States.
- The approval is supported by positive topline clinical efficacy results.
- Menkes disease is a rare X-linked recessive pediatric disease caused by mutations of the copper transporter ATP7A.
- ZYCUBO® is a subcutaneous injectable formulation of copper histidinate that restores copper homeostasis and maintains copper levels in patients with Menkes disease.
- Sentynl Therapeutics Inc. acquired ZYCUBO from Cyprium Therapeutics in 2023 and advanced it through the final stages of development with the FDA.