Zydus Lifesciences’ arm gets USFDA’s nod for ZYCUBO

Zydus Lifesciences Ltd. | Pharmaceuticals & Drugs | Healthcare | BSE: 532321 | NSE: ZYDUSLIFE

13 Jan 2026 Evaluate

Zydus Lifesciences’ wholly owned subsidiary -- Sentynl Therapeutics Inc. (Sentynl), a U.S. based biopharmaceutical company, has received U.S. Food and Drug Administration’s (USFDA's) approval for 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. ZYCUBO is not indicated for the treatment of Occipital Horn Syndrome.

Menkes disease is a rare X-linked recessive pediatric disease caused by mutations of the copper transporter ATP7A encoded by the ATP7A gene. Patients with Menkes disease are born with the inability to absorb dietary copper and subsequently have impaired copper transport across the blood-brain barrier, and, until now, there has been no approved treatment in the United States. ZYCUBO is a subcutaneous injectable formulation of copper histidinate that restores copper homeostasis and maintains copper levels in patients with Menkes disease.

The approval is supported by positive topline clinical efficacy results for ZYCUBO, demonstrating statistically significant improvement in overall survival for Menkes disease subjects who received early treatment (ET) with ZYCUBO, compared to an untreated contemporaneous external control cohort, with a nearly 80% reduction in the risk of death. Median overall survival (OS) was 177.1 months for ZYCUBO ET cohort compared to 17.6 months for the untreated contemporaneous external control cohort.

Acquired from Cyprium Therapeutics in 2023, Sentynl has advanced ZYCUBO through the final stages of development with the FDA based on positive results from pivotal studies, receiving Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and the FDA Orphan Drug Designations. Copper histidinate has also been granted Orphan Designation by the European Medicines Agency.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.

Zydus Lifesciences Share Price

911.85 10.20 (1.13%)

05-May-2026 16:59 View Price Chart

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