Daybue Stix (trofinetide)
New dosage form
- Region
- 🇺🇸 US
- Active substance
- trofinetide
- Company
- Acadia Pharms Inc
- Status
- Approved
- FDA approval
- Thu 11 Dec 2025
- Designations
- New dosage form
- Application
- NDA219884
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Thu 11 Dec 2025🇺🇸 FDA approval
FDA approves Daybue Stix (trofinetide): new dosage form
Acadia Pharms Inc; NDA219884; New dosage form; for solution, solution · source
Same substance in other markets
- 🇪🇺 Daybu Authorised · Acadia Pharmaceuticals B.V.
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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.