ONYDA XR (clonidine hydrochloride) · TRIS PHARMA INC
ONYDA XR treats Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients aged six years and older. It is used as a standalone therapy or as an addition to central nervous system stimulant medications to help patients manage their symptoms. This medication provides a non-stimulant option for children and adolescents requiring treatment for ADHD.
How ONYDA XR Works
This medication works by stimulating alpha 2-adrenergic receptors located in the brain. Unlike many other common ADHD treatments, it does not function as a central nervous system stimulant. While the exact way this process improves ADHD symptoms is not known, the drug acts as a centrally acting alpha 2-adrenergic agonist.
Details
- Status
- Prescription
- First Approved
- 2024-05-24
- Patent Cliff
- 2041
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
ONYDA XR Approval History
What ONYDA XR Treats
1 indicationsONYDA XR is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
ONYDA XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01439126 results posted | SHN-KAP-401 | Ph 4 | completed | Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder |
Active Pipeline
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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.
ONYDA XR FDA Label Details
Indications & Usage
FDA Label (PDF)ONYDA XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy and as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older [see Clinical Studies ]. ONYDA XR is a centrally acting alpha 2 -adrenergic agonist indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) as monotherapy or as adjunctive therapy to central nervous system (CNS) stimulant medications in pediatric patients 6 years of age and older.
Pro Intelligence Preview
Deep insights for ONYDA XR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 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.