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open label PR OROS methylphenidate
open label PR OROS methylphenidate is a Central nervous system stimulant Small molecule drug developed by Janssen-Cilag International NV. It is currently in Phase 3 development for Attention deficit hyperactivity disorder (ADHD).
Methylphenidate is a central nervous system stimulant that works by increasing the levels of dopamine and norepinephrine in the brain.
Open label PR OROS methylphenidate is used to treat Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder With Hyperactivity. It works by inhibiting the sodium-dependent dopamine transporter, a mechanism that affects dopamine levels in the brain.
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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). -
Big-pharma sponsor
+3.0pp
Janssen-Cilag International NV is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| 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 | open label PR OROS methylphenidate |
|---|---|
| Sponsor | Janssen-Cilag International NV |
| Drug class | Central nervous system stimulant |
| Modality | Small molecule |
| Therapeutic area | Attention deficit hyperactivity disorder |
| Phase | Phase 3 |
Mechanism of action
Methylphenidate is a dopamine-norepinephrine reuptake inhibitor, which means it blocks the reabsorption of these neurotransmitters, allowing them to stay in the synaptic cleft for longer periods and increasing their availability for binding to postsynaptic receptors. This leads to increased alertness, attention, and energy levels.
Approved indications
- Attention deficit hyperactivity disorder (ADHD)
Common side effects
- Nausea
- Headache
- Insomnia
- Anxiety
- Dizziness
Key clinical trials
- Open Label, Multicentre Extension Study of Protocol 42603ATT3002 to Evaluate Safety of Prolonged Release OROS Methlyphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) (PHASE3)
- Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (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:
- open label PR OROS methylphenidate CI brief — competitive landscape report
- open label PR OROS methylphenidate updates RSS · CI watch RSS
- Janssen-Cilag International NV portfolio CI
Frequently asked questions about open label PR OROS methylphenidate
What is open label PR OROS methylphenidate?
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Related
- Drug class: All Central nervous system stimulant drugs
- Manufacturer: Janssen-Cilag International NV — full pipeline
- Therapeutic area: All drugs in Attention deficit hyperactivity disorder
- Indication: Drugs for Attention deficit hyperactivity disorder (ADHD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing