Methylphenidate Hydrochloride is named as an intervention in 2 current clinical trials in our Netherlands and Canada registers. 2 are recruiting patients now. All registered phases are Phase 4. The sponsor with the most trials is Radboud University Medical Center (1). The most-studied condition is Kbg Syndrome.
Of the three regulators tracked here, the first to approve Methylphenidate Hydrochloride 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.
Protections still running for marketed products containing Methylphenidate Hydrochloride, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 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.
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.
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), 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, which decides whether the NHS in England should fund new medicines, has published 2 technology appraisals of Methylphenidate Hydrochloride. 1 is current, and 1 of it recommends it for at least some patients. 1 older appraisal was replaced or withdrawn.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.
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
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.
| Study | Phase | Status | Lead sponsor | Registers |
|---|
Registers 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.
| Lead sponsor | Trials |
|---|---|
| Radboud University Medical Center | 1 |
| Dar Clinical Research Inc | 1 |
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in Netherlands | 1 | 1 |
| Clinical trials in Canada | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
2 current trials in our Netherlands and Canada registers name Methylphenidate Hydrochloride as a drug or biological intervention, as of the registry sync on 8 October 2026. Completed and withdrawn studies are not counted.
Yes. 2 of the 2 trials are recruiting: 1 with sites in Netherlands and 1 with sites in Canada. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Radboud University Medical Center (1) and Dar Clinical Research Inc (1). The number in brackets is how many trials each organisation leads.
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 Hydrochloride works or whether it is effective, and it is not medical advice.
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Methylphenidate Hydrochloride works or whether it is effective. Each trial links to its own record so you can check it yourself.
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Methylphenidate Hydrochloride (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 8 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.
