trofinetide
trofinetide: sourced relationships with 1 company · 4 clinical trials tracked · 2 FDA decisions.
trofinetide evidence translation
What we can confirm
2 FDA records · 4 tracked trials
What it means
What to watch
Prepared research question
How could trofinetide → ACAD affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| ACADIA PHARMACEUTICALS INC (ACAD) | Approved |
| ACADIA PHARMACEUTICALS INC (ACAD) Reported 2023-03-10 · Current development: unknownSource | Phase 3 |
Clinical Trial Registry Records (4)
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Primary endpoint: Safety and Tolerability of Treatment With Oral Trofinetide
An Open-Label Extension Study of Continuing Treatment With Trofinetide for Rett Syndrome
Primary endpoint: Percentage of Patients With Treatment-emergent Adverse Events (TEAEs), With Serious Adverse Events (SAEs), and With Withdrawals Due to AEs
A 40-Week, Open-label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
Primary endpoint: Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs), Percentage of Subjects With Serious Adverse Events (SAEs), and Percentage of Subjects With Withdrawals Due to AEs
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
Primary endpoint: Rett Syndrome Behaviour Questionnaire (RSBQ) Total Score - Change From Baseline to Week 12
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with trofinetide?
trofinetide has dated SEC/FDA relationship records for ACADIA PHARMACEUTICALS INC.
How many clinical trials involve trofinetide?
BioSniper tracks 4 clinical trials involving trofinetide.
What is trofinetide's latest FDA decision?
The most recent tracked FDA decision for trofinetide is Approval for 1 INDICATIONS AND USAGE DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. ( 1 ), dated December 11, 2025.