The US FDA New Drug Approvals in January 2026 

Shots: 

• Approval numbers were lower, but the impact remained strong the FDA cleared one new drug in January 2026 versus three in January 2025, reflecting continued innovation in areas of high unmet need 

• Zycubo from Sentynl Therapeutics was approved for pediatric Menkes disease, offering a targeted treatment for this rare, life-threatening genetic copper deficiency disorder 

• Clinical results were striking, showing about an 80% reduction in risk of death and a major survival gain of 177.1 months versus 17.6 months in untreated patients, with Zycubo providing daily subcutaneous bioavailable copper replacement 

1. Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease 

               Company: Sentynl Therapeutics 

               Product: Zycubo 

               Active Ingredient: Copper Histidinate 

               Disease: Pediatric Menkes Disease 

               Date: Jan 12, 2026   

               Shots: 

• The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease 

• Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos. 

• Zycubo is a bioavailable copper replacement therapy for Menkes disease, delivered as a daily SC injectable copper histidinate to supply elemental copper 

Related Post: Insights+: The US FDA New Drug Approvals in December 2025