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Methylphenidate (OROS-MPH)
Methylphenidate (OROS-MPH) is a Sympathomimetic amine; CNS stimulant Small molecule drug developed by University of Cincinnati. It is currently in Phase 3 development for Attention-deficit/hyperactivity disorder (ADHD), Narcolepsy.
Methylphenidate is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the synapse.
Methylphenidate is a central nervous system stimulant that increases dopamine and norepinephrine activity in the brain by blocking their reuptake at the synapse. Used for Attention-deficit/hyperactivity disorder (ADHD), Narcolepsy.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Methylphenidate (OROS-MPH) |
|---|---|
| Sponsor | University of Cincinnati |
| 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
OROS-MPH (osmotic-release oral system methylphenidate) is an extended-release formulation of methylphenidate that provides sustained dopamine and norepinephrine reuptake inhibition throughout the day. This mechanism enhances attention, focus, and impulse control by increasing catecholamine levels in key brain regions involved in executive function and attention. The OROS delivery system uses osmotic pressure to gradually release the drug over 8-12 hours, providing consistent therapeutic levels.
Approved indications
- Attention-deficit/hyperactivity disorder (ADHD)
- Narcolepsy
Common side effects
- Insomnia
- Decreased appetite
- Headache
- Nervousness/anxiety
- Abdominal pain
- Tachycardia
- Elevated blood pressure
Key clinical trials
- Benefits of ADHD Treatment in Detained People (PHASE3)
- The Effects of ADHD Medication (TEAM) Study (PHASE4)
- Real-World Evidence of Duration of Effect of Adhansia XR (Extended-Release) for Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) (PHASE4)
- The Study of Efficacy and Safety of Generic Methylphenidate Prolong-released Comparison With Original (NA)
- Pharmacogenetic Studies on Attention Deficit Hyperactivity Disorder
- Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 (PHASE3)
- Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder (PHASE4)
- Effectiveness of Vyvanse Compared to Concerta in Adolescents With Attention-deficit/Hyperactivity Disorder (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:
- Methylphenidate (OROS-MPH) CI brief — competitive landscape report
- Methylphenidate (OROS-MPH) updates RSS · CI watch RSS
- University of Cincinnati portfolio CI
Frequently asked questions about Methylphenidate (OROS-MPH)
What is Methylphenidate (OROS-MPH)?
How does Methylphenidate (OROS-MPH) work?
What is Methylphenidate (OROS-MPH) used for?
Who makes Methylphenidate (OROS-MPH)?
What drug class is Methylphenidate (OROS-MPH) in?
What development phase is Methylphenidate (OROS-MPH) in?
What are the side effects of Methylphenidate (OROS-MPH)?
What does Methylphenidate (OROS-MPH) target?
Related
- Drug class: All Sympathomimetic amine; CNS stimulant drugs
- Target: All drugs targeting Dopamine transporter (DAT); Norepinephrine transporter (NET)
- Manufacturer: University of Cincinnati — full pipeline
- Therapeutic area: All drugs in Neurology / Psychiatry
- Indication: Drugs for Attention-deficit/hyperactivity disorder (ADHD)
- Indication: Drugs for Narcolepsy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing