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 10m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAYBUE (trofinetide) is an oral solution small molecule approved in March 2023 for rare neurological indications. It functions as a cytochrome P450 3A4 inhibitor, modulating synaptic transmission through a novel mechanism. The drug addresses an unmet need in a pediatric-focused patient population with limited treatment alternatives.
$0.019BPart D
Peak16.6 years to LOEEarly-stage peak revenue with modest Medicare penetration (320 Part D claims in 2023) suggests growing adoption trajectory and expanding team investment.
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
Working on DAYBUE provides access to 46 linked career opportunities with significant director-level and specialized analytical roles spanning clinical, translational, and financial functions. The rare disease focus and CYP3A4 inhibitor mechanism create unique expertise domains relevant to both Acadia and broader pharma talent markets.
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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.