NDAORALFOR SOLUTION
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
6/8 — Strong
DAYBUE STIX (trofinetide) by Acadia Pharmaceuticals is cytochrome p450 3a4 inhibitors [moa]. Approved for rett syndrome. First approved in 2025.
Drug data last refreshed 22h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DAYBUE STIX (trofinetide) is an oral solution formulation of trofinetide, a cytochrome P450 3A4 inhibitor approved for Rett syndrome. It represents a new delivery format for the same active ingredient as the existing DAYBUE brand, designed to improve patient adherence and dosing convenience. Trofinetide works by modulating a key neurobiological pathway implicated in Rett syndrome pathogenesis.
Growth16.7 years to LOE
This is a freshly approved launch-stage product with no direct market competition, positioning the commercial team to establish initial uptake and market education in a rare disease setting.
Mechanism 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.