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Aptensio XR
Aptensio XR is a Sympathomimetic amine; CNS stimulant Small molecule drug developed by Rhodes Pharmaceuticals, L.P.. It is currently FDA-approved for Attention-deficit/hyperactivity disorder (ADHD) in children and adults. Also known as: Methylphenidate Extended Release, methylphenidate, extended release.
Aptensio XR is an extended-release formulation of methylphenidate that increases dopamine and norepinephrine activity in the central nervous system to improve attention and reduce hyperactivity.
Aptensio XR is a small molecule medication used to treat Attention Deficit Disorder With Hyperactivity, Attention-Deficit/Hyperactivity Disorder (ADHD), and Autism Spectrum Disorder. It is an extended-release formulation of methylphenidate hydrochloride, a central nervous system stimulant.
At a glance
| Generic name | Aptensio XR |
|---|---|
| Also known as | Methylphenidate Extended Release, methylphenidate, extended release |
| Sponsor | Rhodes Pharmaceuticals, L.P. |
| 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
Methylphenidate is a sympathomimetic amine that blocks the reuptake of dopamine and norepinephrine at the presynaptic neuron, increasing their concentration in the synaptic cleft. The extended-release formulation provides sustained drug delivery over 12 hours, allowing once-daily dosing. This mechanism enhances executive function, attention span, and impulse control in patients with attention-deficit/hyperactivity disorder.
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD) in children and adults
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Abdominal pain
- Nervousness
- Tachycardia
- Elevated blood pressure
Key clinical trials
- Treating Young Children With Attention Deficit Hyperactivity Disorder (PHASE4)
- AWARE: Management of ADHD in Autism Spectrum Disorder (PHASE4)
- Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits (PHASE4)
- A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD (PHASE4)
- Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD (PHASE4)
- A 12-Month Open Label Safety Study of Aptensio XR® in Children Ages 4-5 Years Diagnosed With ADHD (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:
- Aptensio XR CI brief — competitive landscape report
- Aptensio XR updates RSS · CI watch RSS
- Rhodes Pharmaceuticals, L.P. portfolio CI
Frequently asked questions about Aptensio XR
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Related
- Drug class: All Sympathomimetic amine; CNS stimulant drugs
- Target: All drugs targeting Dopamine transporter (DAT); Norepinephrine transporter (NET)
- Manufacturer: Rhodes Pharmaceuticals, L.P. — full pipeline
- Therapeutic area: All drugs in Psychiatry/Neurology
- Indication: Drugs for Attention-deficit/hyperactivity disorder (ADHD) in children and adults
- Also known as: Methylphenidate Extended Release, methylphenidate, extended release
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing