NDAORALSOLUTIONPriority Review
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
7/8 — Comprehensive
Priority Review
DAYBUE (trofinetide) by Acadia Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. Approved for rett syndrome. First approved in 2023.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAYBUE (trofinetide) is an oral solution approved by the FDA on March 10, 2023, for the treatment of Rett syndrome in adults and older patients. The drug functions as a cytochrome P450 3A4 inhibitor, a mechanism that appears designed to modulate cellular processes relevant to this severe neurological disorder. DAYBUE represents a significant advancement as it addresses an indication with limited treatment options, positioning itself as a potentially disease-modifying therapy in a rare disease landscape with high unmet medical need.
$0.0BPart D
16.7 years to LOEMechanism of Action
Cytochrome P450 3A4 Inhibitors
Indications (1)
Clinical Trials (4)
An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome
Started Sep 2021
15 enrolled
Rett Syndrome
Open-Label Extension Study of Trofinetide for Rett Syndrome
Started Nov 2020
77 enrolled
Rett Syndrome
Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome
Started Jan 2020
154 enrolled
Rett Syndrome
Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)
Started Nov 2019
187 enrolled
Rett Syndrome
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.