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Methylphenidate, non-retard
Methylphenidate, non-retard is a Central nervous system stimulant Small molecule drug developed by Wuerzburg University Hospital. 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.
Methylphenidate is a central nervous system stimulant that works by increasing the levels of dopamine and norepinephrine in the brain. Used for Attention deficit hyperactivity disorder (ADHD).
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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, non-retard |
|---|---|
| Sponsor | Wuerzburg University Hospital |
| Drug class | Central nervous system stimulant |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
This is achieved by inhibiting the reuptake of these neurotransmitters, leading to increased activity in the brain. As a result, methylphenidate can help improve attention and reduce impulsivity in individuals with attention deficit hyperactivity disorder (ADHD).
Approved indications
- Attention deficit hyperactivity disorder (ADHD)
Common side effects
- Nervousness
- Insomnia
- Headache
- Anxiety
- Dizziness
Key clinical trials
- Genetic Modulation of Working Memory in Attention Deficit Hyperactivity Disorder (ADHD) (PHASE3)
- Identification of Neuropsychological, Genetic and Neuroimaging Markers and Treatment Response Predictors of ADHD
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, non-retard CI brief — competitive landscape report
- Methylphenidate, non-retard updates RSS · CI watch RSS
- Wuerzburg University Hospital portfolio CI
Frequently asked questions about Methylphenidate, non-retard
What is Methylphenidate, non-retard?
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Who makes Methylphenidate, non-retard?
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What development phase is Methylphenidate, non-retard in?
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Related
- Drug class: All Central nervous system stimulant drugs
- Manufacturer: Wuerzburg University Hospital — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Attention deficit hyperactivity disorder (ADHD)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing