DAYBUE (trofinetide)
Daybue is a medication used for individuals diagnosed with Rett syndrome. It is prescribed for a broad patient population, including adults and children as young as two years old. This therapy helps patients manage the symptoms associated with the condition.
How DAYBUE Works
The specific way trofinetide works to produce its therapeutic effects in the body is currently not fully understood. While it helps patients with Rett syndrome, the exact biological targets or pathways it influences remain unknown.
Details
- Status
- Prescription
- First Approved
- 2023-03-10
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- SOLUTION
DAYBUE Approval History
What DAYBUE Treats
1 indicationsDAYBUE is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rett Syndrome
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Clinical Trial Registry
4 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04776746 results posted | ACP-2566-005 | Ph 3 | terminated | Open-Label Extension Study of Trofinetide for Rett Syndrome |
| NCT04988867 DAFFODIL™ results posted | ACP-2566-009 | Ph 2, Ph 3 | terminated | An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome |
| NCT04279314 LILAC™ results posted | ACP-2566-004 | Ph 3 | completed | Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome |
| NCT04181723 results posted | ACP-2566-003 | Ph 3 | completed | Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DAYBUE FDA Label Details
Indications & Usage
FDA Label (PDF)DAYBUE is indicated for the treatment of Rett Syndrome.
DAYBUE Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DAYBUE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 8 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.