NDAORALSOLUTIONPriority Review
Approved
Mar 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
6/8 — Strong
Priority Review
DAYBUE (trofinetide) by Acadia Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. First approved in 2023.
Drug data last refreshed 10h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAYBUE (trofinetide) is an oral solution small molecule approved in March 2023 for Rett syndrome. It functions as a cytochrome P450 3A4 inhibitor and represents a novel mechanism of action for this severe neurological disorder. The drug targets a pediatric population with limited prior treatment options.
$19MPart D
PeakGrowing
16.3 years to LOEEarly-stage peak product in a rare disease market with strong patent protection and emerging adoption trajectory supporting sustained commercial team expansion.
Mechanism of Action
Cytochrome P450 3A4 Inhibitors
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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
Career Relevance
DAYBUE roles span 44 open positions across commercial, medical, QA, and data science functions, reflecting peak-stage product investment. Career opportunities emphasize rare disease commercial expertise, patient access navigation, and data analytics rather than clinical research.
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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.