DYANAVEL XR (amphetamine)
DYANAVEL XR is a central nervous system stimulant used for patients 6 years of age and older who have Attention Deficit Hyperactivity Disorder (ADHD). This medication helps patients manage their symptoms through its activity as a sympathomimetic amine. It is not recommended for children under the age of 6, as younger patients may experience higher levels of the drug in their system and a greater risk of side effects like weight loss.
How DYANAVEL XR Works
This drug works by acting as a non-catecholamine sympathomimetic amine with stimulant activity in the central nervous system. While it functions as a central nervous system stimulant, the specific way it produces a therapeutic effect in patients with ADHD is not currently known.
Details
- Status
- Prescription
- First Approved
- 2015-10-19
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- SUSPENSION, EXTENDED RELEASE
Companies
DYANAVEL XR Approval History
What DYANAVEL XR Treats
1 indicationsDYANAVEL XR is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Attention Deficit Hyperactivity Disorder
DYANAVEL XR Boxed Warning
ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educa...
WARNING: ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10) ] , and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Precautions (5.1) , Drug Abuse and Dependence (9.2) ] . WARNING: ABUSE, MISUSE, AND ADDICTION See full prescribing information for complete boxed warning. DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death ( 5.1 , 9.2 , 10 ): Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout treatment, reassess each patient’s risk and frequently monitor for signs and symptoms of abuse, misuse, and addiction.
DYANAVEL XR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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.
Drugs Similar to DYANAVEL XR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06248229 | Dyan24 | Ph 4 | recruiting | A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD). |
| NCT03242772 results posted | Pro00085179 1P50HD093074-01 | Ph 2 | terminated | Impact of Combined Medication and Behavioral Treatment for ASD & ADHD |
| NCT02959892 results posted | TAK-041-1002 U1111-1184-1947, 2016-002346-23 | Ph 1 | completed | A Single-Dose Positron Emission Tomography (PET) Study to Determine the Effect of TAK-041 on Amphetamine-Induced Dopamine Release in the Central Nervous System (CNS) |
| NCT02020408 results posted | 090661 R01MH092793 | Ph 4 | completed | Monoamine Contributions to Neurocircuitry in Eating Disorders |
| NCT00733993 results posted | DA09262 P50DA009262, DPMCDA | Ph 1, Ph 2 | completed | Caffeine and Cocaine |
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.
DYANAVEL XR FDA Label Details
Indications & Usage
FDA Label (PDF)DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder.
WARNING: ABUSE, MISUSE, AND ADDICTION DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death [see Overdosage (10) ] , and th...
DYANAVEL XR Patents & Exclusivity
Patents (7 active)
Pro Intelligence Preview
Deep insights for DYANAVEL XR
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2036
- • 7 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.