Zycubo (copper histidinate)
New molecular entityPriority review
- Region
- 🇺🇸 US
- Active substance
- copper histidinate
- Company
- Sentynl Theraps Inc
- Status
- Approved
- FDA approval
- Mon 12 Jan 2026
- Designations
- New molecular entity, Priority review
- Application
- NDA211241
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Mon 12 Jan 2026🇺🇸 FDA approval
FDA approves Zycubo (copper histidinate), a new medicine
Sentynl Theraps Inc; NDA211241; New molecular entity, Priority review; powder · source
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.