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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: copper histidinate
Trade Name: Zycubo
Date Designated: 05/14/2012
Orphan Designation: Treatment of Menkes disease
Orphan Designation Status: Designated/Approved
Sentynl Therapeutics, Inc.
420 Stevens Ave., Suite 200
Solana Beach, California 92075
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: copper histidinate
Trade Name: Zycubo
Marketing Approval Date: 01/12/2026
Approved Labeled Indication: treatment of Menkes disease in pediatric patients
Exclusivity End Date: TBD  
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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