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Focalin XR
Focalin XR is an extended-release formulation of dexmethylphenidate that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the presynaptic neuron.
Focalin XR is an extended-release formulation of dexmethylphenidate that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the presynaptic neuron. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adults.
At a glance
| Generic name | Focalin XR |
|---|---|
| Sponsor | Novartis |
| Drug class | Central nervous system stimulant |
| Target | Dopamine transporter (DAT), Norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | FDA-approved |
Mechanism of action
Dexmethylphenidate is the active d-isomer of methylphenidate, a central nervous system stimulant. It works by inhibiting the reuptake of dopamine and norepinephrine, thereby increasing their concentration in the synaptic cleft and enhancing neurotransmission in brain regions responsible for attention and impulse control. The XR formulation provides sustained release over approximately 12 hours.
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD) in children and adults
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Nervousness
- Abdominal pain
- Tachycardia
- Increased blood pressure
Key clinical trials
- Treating Young Children With Attention Deficit Hyperactivity Disorder (PHASE4)
- AWARE: Management of ADHD in Autism Spectrum Disorder (PHASE4)
- Stimulant Effects on Disruptive Behavior (PHASE4)
- Dexmethylphenidate Hydrochloride Tablets Under Non-Fasting Conditions (PHASE1)
- Dexmethylphenidate Hydrochloride Tablets Under Fasting Conditions (PHASE1)
- Stimulant Medication Effects on Auditory Sensitivity in Teens With ADHD
- Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder (PHASE4)
- CTx-1301 Comparative Bioavailability Study (PHASE1, PHASE2)
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:
- Focalin XR CI brief — competitive landscape report
- Focalin XR updates RSS · CI watch RSS
- Novartis portfolio CI