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PRC-063
PRC-063 is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition for ADHD symptom management.
PRC-063 is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition for ADHD symptom management. Used for Attention-deficit/hyperactivity disorder (ADHD) in children and adults.
At a glance
| Generic name | PRC-063 |
|---|---|
| Also known as | Methylphenidate |
| Sponsor | Rhodes Pharmaceuticals, L.P. |
| Drug class | Stimulant; dopamine and norepinephrine reuptake inhibitor |
| Target | Dopamine transporter (DAT); norepinephrine transporter (NET) |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Neurology |
| Phase | Phase 3 |
Mechanism of action
PRC-063 is a once-daily extended-release methylphenidate product designed to maintain therapeutic levels throughout the day. Methylphenidate works by inhibiting the reuptake of dopamine and norepinephrine in the central nervous system, increasing their availability at synaptic sites. This mechanism helps improve attention, focus, 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
- Increased heart rate
- Anxiety
Key clinical trials
- PRC-063 Adult Laboratory Classroom Study in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) (PHASE3)
- PRC-063 Classroom Study in Children (6-12 Years of Age) With ADHD (PHASE3)
- The Efficacy and Safety of PRC-063 in Adult ADHD Patients (PHASE3)
- A Comparison of PRC-063 and Lisdexamfetamine in the Driving Performance of Adults With ADHD (PHASE3)
- PRC-063 in an ADULT Workplace Environment (PHASE3)
- PRC-063 in Adolescent ADHD (PHASE3)
- Long-Term Safety of PRC-063 in Adolescents and Adults With ADHD (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:
- PRC-063 CI brief — competitive landscape report
- PRC-063 updates RSS · CI watch RSS
- Rhodes Pharmaceuticals, L.P. portfolio CI