NDASUBCUTANEOUSPOWDERPriority Review
Approved
Jan 2026
Lifecycle
Launch
Competitive Pressure
18/100
Clinical Trials
1
Data completeness
2/8 — Basic
Priority Review
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYCUBO (copper histidinate) is a subcutaneous powder formulation approved January 2026 for treating copper deficiency disorders. The drug delivers bioavailable copper via a novel histidinate complex to restore physiological copper levels.
Launch4.6 years to LOE
Early-stage launch product with moderate competitive pressure (18); team will focus on market penetration and formulary access strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Copper Histidinate Treatment for Menkes Disease
Menkes Disease
Why This Matters for Your Career
LOE in ~5 years — strategic planning for patent cliff underway
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.