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Dyanavel XR
Dyanavel XR is an extended-release liquid formulation of amphetamine that increases the release of dopamine and norepinephrine in the central nervous system to improve attention and reduce hyperactivity.
Dyanavel XR is an extended-release liquid formulation of amphetamine that increases the release of dopamine and norepinephrine in the central nervous system to improve attention and reduce hyperactivity. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents.
At a glance
| Generic name | Dyanavel XR |
|---|---|
| Sponsor | Rochester Center for Behavioral Medicine |
| Drug class | Sympathomimetic amine; CNS stimulant |
| Target | Dopamine transporter (DAT); Norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | FDA-approved |
Mechanism of action
Amphetamine is a sympathomimetic amine that acts as a central nervous system stimulant by promoting the release of catecholamines (dopamine and norepinephrine) from presynaptic neurons and inhibiting their reuptake. The extended-release formulation provides sustained therapeutic levels throughout the day, improving focus, attention, and impulse control in patients with ADHD. This mechanism helps normalize neurotransmitter activity in brain regions responsible for executive function and behavioral control.
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD) in children and adolescents
Common side effects
- Decreased appetite
- Insomnia
- Headache
- Abdominal pain
- Irritability
- Tachycardia
Key clinical trials
- The TEAM Study - Treatment Efficacy for Autism/Attention Using Mixed Amphetamine (PHASE4)
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- AWARE: Management of ADHD in Autism Spectrum Disorder (PHASE4)
- ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disorder (PHASE4)
- Biomarkers of ADHD Treatment Response (PHASE1)
- A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD). (PHASE4)
- Adderall XR and Cognitive Impairment in MS (PHASE2, PHASE3)
- Neuroimaging Study of Risk Factors for Adolescent Bipolar Disorder (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Dyanavel XR CI brief — competitive landscape report
- Dyanavel XR updates RSS · CI watch RSS
- Rochester Center for Behavioral Medicine portfolio CI