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Methylphenidate Extended Release Capsules
Methylphenidate is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the presynaptic neuron.
Methylphenidate 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, Narcolepsy.
At a glance
| Generic name | Methylphenidate Extended Release Capsules |
|---|---|
| Also known as | Biphentin |
| Sponsor | UCB Pharma |
| Drug class | Sympathomimetic amine; central nervous system stimulant |
| Target | Dopamine transporter (DAT); Norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Neurology; Psychiatry |
| Phase | FDA-approved |
Mechanism of action
Methylphenidate inhibits the reuptake of dopamine and norepinephrine by blocking dopamine and norepinephrine transporters, leading to increased concentrations of these neurotransmitters in the synaptic cleft. This enhanced neurotransmitter activity improves attention, focus, and impulse control. The extended-release formulation provides sustained drug delivery over an extended period, allowing for once-daily dosing.
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD) in children and adults
- Narcolepsy
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Nervousness or anxiety
- Abdominal pain
- Tachycardia
- Elevated blood pressure
Key clinical trials
- A Trial to Assess How Centanafadine Interacts With Stimulants in the Body (PHASE1)
- An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening (PHASE4)
- Safety and Tolerability Study of Adhansia XR® Extended-Release Capsules in Children (PHASE4)
- Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) (PHASE4)
- A Pilot of Methylphenidate in Mild Cognitive Impairment and Dementia Participants. (PHASE4)
- Efficacy and Safety of Methylphenidate HCl ER Capsules in Children and Adolescents With ADHD (PHASE3)
- A Flexible-Dose Titration Study of Aptensio XR in Children Ages 4 to Under 6 Years Diagnosed With ADHD (PHASE4)
- Time Course of Response to Methylphenidate HCl ER Capsules in Children 6 to 12 Years With ADHD in Classroom Setting (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Methylphenidate Extended Release Capsules CI brief — competitive landscape report
- Methylphenidate Extended Release Capsules updates RSS · CI watch RSS
- UCB Pharma portfolio CI