Methylphenidate clinical trials
Methylphenidate is named as an intervention in 13 current clinical trials in our Canada, Taiwan, Israel, France, Sweden, Denmark, Poland, Mexico and Brazil registers. 13 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Sunnybrook Health Sciences Centre (2). The most-studied condition is ADHD. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Methylphenidate is approved
All regulators →Of the three regulators tracked here, the first to approve Methylphenidate was the US, on 5 Dec 1955. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Methylphenidate patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Methylphenidate, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 40 listed patents; the last listed expires 25 Jan 2038 (US 11166947).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Methylphenidate
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Methylphenidate works
All drug targets →- Dopamine transporter inhibitor InhibitorTarget: SLC6A3 solute carrier family 6 member 3✓ In ChEMBL and the Guide to Pharmacology
- Norepinephrine transporter inhibitor InhibitorTarget: SLC6A2 solute carrier family 6 member 2✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- ApathyPhase 3
- Cannabis usePhase 3
- FatiguePhase 3
- HIV-associated neurocognitive disorderPhase 3
- HyperactivityPhase 3
- AnxietyPhase 3
- AstheniaPhase 3
- Attention deficit hyperactivity disorder, inattentive typePhase 3
- Autism spectrum disorderPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL796, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7236, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Methylphenidate
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Methylphenidate. 1 is current, and 1 of it recommends it for at least some patients. 1 older appraisal was replaced or withdrawn.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Methylphenidate, atomoxetine and dexamfetamine for attention deficit hyperactivity disorder (ADHD) in children and adolescents NICE TA98 | Recommended | 22 Mar 2006 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Methylphenidate
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 18 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: TuzulbyEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Methylphenidate
- ATC code
- N06BA04
- ChEMBL
- CHEMBL796
- DrugBank
- DB00422
- PubChem CID
- 4158
- CAS number
- 113-45-1
- FDA UNII
- 207ZZ9QZ49
- Wikidata
- Q422112
- Wikipedia
- Methylphenidate
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Methylphenidate
13 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Methylphenidate in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Methylphenidate. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Methylphenidate for Early Awakening in Coma (MEAWAKE)
2025-524937-19-00 · CTIS ↗ · Nervous System Diseases
|
Phase 2 | Authorised | Rigshospitalet | Austria, Denmark, Germany + 1 more |
Methylphenidate across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
18 single-substance products containing Methylphenidate on the HPRA medicines list.
- Concerta XL 27 mg prolonged-release tabletsJanssen Sciences Ireland Unlimited Company · PA22612/002/004 · Marketed
- Equasym XL 10 mg modified-release capsules, hardTakeda Pharmaceuticals International AG Ireland Branch · PA23211/001/001 · Marketed
- Equasym XL 20 mg modified-release capsules, hardTakeda Pharmaceuticals International AG Ireland Branch · PA23211/001/002 · Marketed
- Equasym XL 30 mg modified-release capsules, hardTakeda Pharmaceuticals International AG Ireland Branch · PA23211/001/003 · Marketed
- Medikinet 10 mg tabletsMedice Arzneimittel Putter GmbH & Co. K.G · PA1555/001/007 · Marketed
Supply shortages
- ADHD medicinesEU (EMA) · Shortage ongoing · first published 18 Dec 2023
- Methylphenidate Hydrochloride Tablet, Extended ReleaseUS (FDA) · Current · updated 3 Nov 2026
- Methylphenidate Film, Extended ReleaseUS (FDA) · Current · updated 16 Oct 2026
Recent approvals
- Methylphenidate HydrochlorideFDA · 15 Sep 2016 · Generic (ANDA) · Alvogen
Conditions studied with Methylphenidate
22 conditionsAll 22 conditions
| Condition (as registered) | Trials |
|---|---|
| ADHD | 2 |
| Methylphenidate | 2 |
| Alzheimer Disease | 2 |
| Posttraumatic Stress Disorder | 2 |
| Adult ADHD | 1 |
| Adult-onset ADHD With Mood Disorder | 1 |
| Brain Tumor, Pediatric | 1 |
| Cancer-related Fatigue | 1 |
| Attention Deficit Disorder with Hyperactivity | 1 |
| Diabetes Mellitus, Type 1 | 1 |
| Apathy in Dementia | 1 |
| Dementia | 1 |
| Mild Behavioural Impairment | 1 |
| Lactating Women on Select DOI | 1 |
| Breastfed Infants of Mothers on Select DOI | 1 |
| Chronic Neuropathic Pain | 1 |
| Alzheimer s Disease | 1 |
| Alzheimer Dementia (AD) | 1 |
| Alzheimer Dementia | 1 |
| Attention Deficit Disorder With Hyperactivity | 1 |
| Metabolomics | 1 |
| PTSD | 1 |
Sponsors
lead sponsor per trialBy country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Methylphenidate trials
How many clinical trials are testing Methylphenidate?
13 current trials in our Canada, Taiwan, Israel, France, Sweden, Denmark, Poland, Mexico and Brazil registers name Methylphenidate as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Methylphenidate trials recruiting patients?
Yes. 13 of the 13 trials are recruiting: 4 with sites in Canada, 2 with sites in Taiwan, 2 with sites in Israel, 1 with sites in France, 1 with sites in Sweden, 1 with sites in Denmark, 1 with sites in Poland, 1 with sites in Mexico and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Methylphenidate clinical trials?
Sunnybrook Health Sciences Centre (2), National Taiwan University Hospital (2), University of Haifa (2) and University Hospital, Strasbourg, France (1), among 10 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Methylphenidate licensed in Ireland?
Yes. The HPRA medicines list includes 18 single-substance products containing Methylphenidate, for example Concerta XL 27 mg prolonged-release tablets (Janssen Sciences Ireland Unlimited Company). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Methylphenidate shortage?
The registers we track list 3 entries for Methylphenidate: ADHD medicines (EU: shortage ongoing); US FDA: current; US FDA: current. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Methylphenidate works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Methylphenidate works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Methylphenidate (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.