Treats Menkes disease. NDA 211241, held by Sentynl Theraps Inc. Copper Histidinate.
As of Nov 14, 2026, NDA 211241 (Zycubo), held by Sentynl Theraps Inc, was first approved by FDA on Jan 12, 2026, with 0 approved supplements and 1 published complete response letter.
ZYCUBO is indicated for the treatment of Menkes disease in pediatric patients.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 12, 2026 | Original applicationNew molecular entity · Priority review | Approved |
| Letter | Product | Now |
|---|---|---|
| Sep 30, 2025 | Copper histidinateFacility Inspections | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zycubo2.9MG/VIAL · powder;subcutaneous | Copper Histidinate | RxReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
