Zydus Lifesciences Limited has informed the Exchange regarding a press release dated January 13, 2026, titled "Sentynl Therapeutics Inc. Announces FDA Approval of ZYCUBO® (copper histidinate)".
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Zydus Lifesciences' wholly-owned U.S. subsidiary Sentynl Therapeutics has received FDA approval for ZYCUBO® (copper histidinate), making it the first and only therapy approved for Menkes disease, a rare and fatal genetic disorder, in the United States. Menkes disease affects around 1 in 34,810 male births, and most untreated patients do not survive beyond 2-3 years of age. Clinical trials showed early treatment with ZYCUBO led to a nearly 80% reduction in the risk of death, with median overall survival of 177.1 months versus 17.6 months in untreated patients. ZYCUBO previously received Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and FDA Orphan Drug Designations, and was acquired by Sentynl from Cyprium Therapeutics in 2023.
This milestone strengthens Zydus's rare disease portfolio and global specialty pipeline, validating its U.S. commercial strategy through Sentynl. While the addressable patient pool is small, exclusivity via Orphan Drug status and first-mover advantage in Menkes disease should support premium pricing and long-term revenue contribution from the U.S. market.