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Dexmethylphenidate HCl extended-release capsules
Dexmethylphenidate HCl is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the presynaptic neuron.
Dexmethylphenidate HCl is a central nervous system stimulant 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 | Dexmethylphenidate HCl extended-release capsules |
|---|---|
| Sponsor | Novartis |
| Drug class | Sympathomimetic amine; CNS stimulant |
| Target | Dopamine transporter (DAT); Norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Neurology/Psychiatry |
| Phase | Phase 3 |
Mechanism of action
Dexmethylphenidate is the active d-isomer of methylphenidate. It works by inhibiting the reuptake of dopamine and norepinephrine, leading to increased concentrations of these neurotransmitters in the synaptic cleft. The extended-release formulation provides sustained drug delivery over an extended period, improving symptom control throughout the day in attention-deficit/hyperactivity disorder (ADHD).
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD) in children and adults
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Abdominal pain
- Nervousness/anxiety
- Tachycardia
- Elevated blood pressure
Key clinical trials
- CTx-1301 Comparative Bioavailability Study (PHASE1, PHASE2)
- Omega-3 Fatty Acid Supplementation to ADHD Pharmacotherapy in ADHD Adults With Deficient Emotional Self-Regulation Traits (PHASE2)
- A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) (PHASE4)
- Efficacy and Safety of Dex-Methylphenidate Extended Release 30 mg Versus 20 mg in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) in a Laboratory Classroom Setting. (PHASE4)
- Efficacy, Tolerability and Safety of Dexmethylphenidate HCl Extended-Release Capsules in Children With Attention-Deficit/Hyperactivity Disorder (PHASE3)
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 |