Active ingredient
Trofinetide
4 finished FDA listings contain Trofinetide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- TROFINETIDE
- Dosage forms
- For Solution, Solution
- Routes
- Oral
- Manufacturers / labelers
- 1
- Strengths listed
- 200 mg/ml · 5000 mg/1 · 6000 mg/1 · 8000 mg/1
- Brand names in FDA listings
- Daybue, Daybue Stix
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 2632852
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 217026 | ACADIA PHARMS INC | 2023-03-10 | 1 |
| NDA 219884 | ACADIA PHARMS INC | 2025-12-11 | 3 |
Official labeling on DailyMed
- DAYBUE (TROFINETIDE) SOLUTION DAYBUE STIX (TROFINETIDE) FOR SOLUTION [ACADIA PHARMACEUTICALS INC.] · version 12 · 2026-09-11
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.