DAYBUE STIX (trofinetide)
Daybue Stix is a medication used for patients with Rett syndrome. It helps both adults and children who are at least two years of age. This therapy provides a treatment option for individuals living with this specific developmental disorder.
How DAYBUE STIX Works
The exact way this medication works to produce its effects is currently unknown. Researchers have not yet identified the specific biological pathway or target it uses to help patients with Rett syndrome.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2025-12-11
- Patent Cliff
- 2043
- Routes
- ORAL
- Dosage Forms
- FOR SOLUTION, SOLUTION
DAYBUE STIX Approval History
What DAYBUE STIX Treats
1 indicationsDAYBUE STIX is approved for 1 conditions since its original approval in 2025. 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 STIX FDA Label Details
Indications & Usage
DAYBUE STIX is indicated for the treatment of Rett Syndrome.
DAYBUE STIX Patents & Exclusivity
Patents (8 active)
Exclusivity
Pro Intelligence Preview
Deep insights for DAYBUE STIX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2043
- • 120 active patents
Trial Analysis
- • 4 total trials
- • Stage: Declining
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.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment