Zydus Lifesciences’ Sentynl Resubmits CUTX-101 NDA to FDA
Filing Summary
Zydus Lifesciences Ltd’s subsidiary, Sentynl Therapeutics, announced the U.S. FDA’s acceptance of its resubmitted New Drug Application (NDA) for CUTX-101, a copper histidinate treatment for Menkes disease. The FDA has set a new PDUFA target action date of January 14, 2026. The resubmission follows a complete response letter regarding cGMP compliance at the manufacturing site. CUTX-101, if approved, will be the first FDA-approved treatment for Menkes disease. The drug has received multiple designations from the FDA and the European Medicines Agency.
Sentynl Therapeutics, a wholly-owned subsidiary of Zydus Lifesciences Ltd, announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for CUTX-101, a copper histidinate treatment for Menkes disease. The FDA has assigned a new Prescription Drug User Fee Act (PDUFA) target action date of January 14, 2026. This acceptance follows a previous complete response letter from the FDA, which addressed observations related to the manufacturing site’s current good manufacturing practice (cGMP) compliance.
The financial terms related to the resubmission of the NDA for CUTX-101 have not been disclosed in the filing. The focus remains on regulatory compliance and the potential approval of the treatment. The acceptance of the NDA resubmission marks a significant procedural step for Sentynl Therapeutics, as it seeks to bring CUTX-101 to market as a treatment for Menkes disease.
CUTX-101 is an investigational subcutaneous injectable formulation of copper histidinate. It is designed to improve tolerability due to its physiological pH. The drug is currently under NDA review with the U.S. FDA for treating patients with Menkes disease. In a Phase 1/2 clinical trial conducted by Stephen G. Kaler, M.D., M.P.H., at the National Institutes of Health, early treatment with CUTX-101 showed improvement in neurodevelopmental outcomes and survival. The drug has demonstrated statistically significant improvement in overall survival for Menkes disease subjects who received early treatment compared to an untreated historical control cohort.
The market context for CUTX-101 is significant, as Menkes disease is a rare X-linked recessive pediatric genetic disorder. It affects an estimated 1 in 34,810 to 1 in 8,664 live male births. The disease is characterized by distinctive clinical features, including sparse and depigmented hair, connective tissue problems, and severe neurological symptoms. Mortality is high in untreated cases, with many patients dying between 2-3 years of age. CUTX-101 has received FDA Breakthrough Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug Designations, as well as Orphan Designation from the European Medicines Agency.
The timeline for the NDA resubmission began with Sentynl’s receipt of a complete response letter from the FDA on September 30, 2025. The resubmission was made on November 14, 2025, and the FDA’s acceptance was announced on December 15, 2025. The new PDUFA target action date is set for January 14, 2026, marking a critical milestone in the regulatory review process.
Zydus Lifesciences Ltd is an innovation-led life-sciences company with leadership positions across pharmaceuticals and consumer wellness. The company is supported by an emerging MedTech franchise and has a global footprint across the United States, India, and other international markets. As of September 30, 2025, the group employs 27,000 people worldwide, including 1,500 scientists engaged in research and development. The group’s mission is to unlock new possibilities in life sciences through quality healthcare solutions.