Last reviewed · How we verify
Daybue (TROFINETIDE)
Daybue works by interacting with a specific target in the body to help manage symptoms of Rett syndrome.
At a glance
| Generic name | TROFINETIDE |
|---|---|
| Sponsor | Acadia Pharms Inc |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
| First approval | 2023 |
| Annual revenue | 300 |
Mechanism of action
The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.
Approved indications
- Rett Syndrome Treatment
Common side effects
- Diarrhea
- Vomiting
- Fever
- Seizure
- Anxiety
- Decreased appetite
- Fatigue
- Nasopharyngitis
Drug interactions
- CYP3A and/or P-gp sensitive substrates
Key clinical trials
- Cognitive Function in Rett Syndrome During Trofinetide Treatment
- Open-Label Extension Study of Trofinetide for Rett Syndrome (PHASE3)
- An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome (PHASE2,PHASE3)
- Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (PHASE3)
- Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™) (PHASE3)
- A Safety Study of NNZ-2566 in Pediatric Rett Syndrome (PHASE2)
- Study of NNZ-2566 in Patients With Traumatic Brain Injury (PHASE2)
- A Safety Study of NNZ-2566 in Patients With Rett Syndrome (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Daybue CI brief — competitive landscape report
- Daybue updates RSS · CI watch RSS
- Acadia Pharms Inc portfolio CI