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Drugs use: methylphenidate
Drugs use: methylphenidate is a Small molecule drug developed by K. Lieb. It is currently in Phase 1 development.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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 | Drugs use: methylphenidate |
|---|---|
| Sponsor | K. Lieb |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Orexin s Role in the Neurobiology of Substance Use Disorder (NA)
- Brain Dopaminergic Signaling in Opioid Use Disorders (EARLY_PHASE1)
- Adaptive Response to Intervention (RTI) for Students With ADHD (PHASE4)
- Behavioral Effects of Drugs: Inpatient (36) (Alcohol, Duloxetine, and Methylphenidate) (PHASE1)
- Stimulant Effects on Disruptive Behavior (PHASE4)
- Mindfulness-Based ADHD Treatment for Children: a Feasibility Study (EARLY_PHASE1)
- The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With ADHD: A Lipidomic Study (NA)
- Effects of Expectation, Medication and Placebo on Objective and Self-rated Performance (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:
- Drugs use: methylphenidate CI brief — competitive landscape report
- Drugs use: methylphenidate updates RSS · CI watch RSS
- K. Lieb portfolio CI
Frequently asked questions about Drugs use: methylphenidate
What is Drugs use: methylphenidate?
Who makes Drugs use: methylphenidate?
What development phase is Drugs use: methylphenidate in?
Related
- Manufacturer: K. Lieb — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing