Trofinetide
As of the edition of 20 October 2026, Trofinetide is a small molecule: marketed, first approved in 2023 (US); US protection ends in 2042.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2026
- Kind
- Small molecule
- Brand name
- Daybue
- First approved
- 10 March 2023 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Acadia Pharmaceuticals; 2 holders in all
- Registered trials
- 12, 3 stopped early
- Disease areas
- Nervous system; Inherited and neonatal; Injuries; Mental health
US protection
US protection ends in 2042.
The last listed US drug-substance patent ends in 2042. The application that gives this date is held by Acadia Pharmaceuticals.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product28 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 28 listings behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 2 | 2 | 0 | 0 |
| Phase 2 | 6 | 5 | 0 | 1 |
| Phase 3 | 4 | 2 | 0 | 2 |
| All trials | 12 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Acadia Pharmaceuticals | Originator, Applicant and Lead sponsor of trials | 2019 to now |