Back to discover
Drug

Methylphenidate hydrochloride

Approved · FDA / EMA
Emerging researchLate-stage developmentRising momentum
Also known as Aptensio, Concerta, Jornay, Metadate+9 more

Aptensio, Concerta, Jornay, Metadate, Methylin, Methylphenidate, QuilliChew, Quillivant, Quillivant XR, Relexxii, Ritalin, Methylphenidylacetate hydrochloride, methylphenidate HCl.

RxNorm203188
3
Research papers
4
Active clinical trials
9
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Label change: METHYLPHENIDATE HYDROCHLORIDE (ANDA206932)

Regulatory2026-07-17FDA

EEG Biomarkers for Pediatric ADHD Treatment Stratification

Clinical trial2026-06-16Results expected Q2 2031 · ClinicalTrials.gov

Multimodal Therapy for the Treatment of Sleep Disturbance in Patients With Cancer

Clinical trial2026-05-22Results posted · ClinicalTrials.gov

USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY

Clinical trial2026-05-19Results expected Q4 2030 · ClinicalTrials.gov

A Phase II Proof-of-concept Trial of Methylphenidate in Children With Apraxia of Speech: a Double-blind, Randomised, Placebo-controlled, Cross-over Trial

Clinical trial2025-10-27Completed · ClinicalTrials.gov

Approval: Tuzulby (EMA)

Regulatory2025-02-28EMA

Effectiveness of Methylphenidate in Children and Adolescents With KBG Syndrome: An N-of-1 Series

Clinical trial2024-12-27Results expected Q1 2027 · ClinicalTrials.gov

Label change: METHYLPHENIDATE HYDROCHLORIDE (ANDA208861)

Regulatory2024-08-16FDA

Label change: METHYLPHENIDATE HYDROCHLORIDE (ANDA206932)

Regulatory2024-06-03FDA

Efficacy of lisdexamfetamine dimesylate throughout the day in children and adolescents with attention-deficit/hyperactivity disorder: results from a randomized, controlled trial.

Research2013-05-25European child & adolescent psychiatry

European, randomized, phase 3 study of lisdexamfetamine dimesylate in children and adolescents with attention-deficit/hyperactivity disorder.

Research2013-01-15European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology

Phase III, randomized, double-blind, placebo-controlled study of long-acting methylphenidate for cancer-related fatigue: North Central Cancer Treatment Group NCCTG-N05C7 trial.

Research2010-07-12Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Methylphenidate hydrochloride
Aliases & brands
AptensioConcertaJornayMetadateMethylinMethylphenidateQuilliChewQuillivantQuillivant XRRelexxiiRitalinMethylphenidylacetate hydrochloridemethylphenidate HCl
RxNorm CUI
203188
Regulatory jurisdictions
fdaema

Regulatory timeline

9 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-05-11
Latest approval
2025-02-28
Authorities
FDA · EMA
Total events
9
fdaU.S. Food and Drug Administration· 8 events
2026-07-17Label change
Label change: METHYLPHENIDATE HYDROCHLORIDE (ANDA206932)
Evidence ↗
2024-08-16Label change
Label change: METHYLPHENIDATE HYDROCHLORIDE (ANDA208861)
Evidence ↗
2024-06-03Label change
Label change: METHYLPHENIDATE HYDROCHLORIDE (ANDA206932)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2025-02-28Approval
Approval: Tuzulby (EMA)
Indication: Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial… Show full indication

Tuzulby is indicated as part of a comprehensive treatment programme for attention-deficit / hyperactivity disorder (ADHD) in children and adolescents 6-17 years old when remedial measures alone prove insufficient. Treatment must be under the supervision of a specialist in childhood behavioural disorders. Diagnosis should be made according to Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria or the guidelines in International Classification of Diseases, Tenth Revision (ICD-10) and should be based on a complete history and evaluation of the patient. Diagnosis cannot be made solely on the presence of one or more symptoms.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

39 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
39
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
3
Recruiting
28
Late-stage (III+)
28
Completed
7
Discontinued
PHASE DISTRIBUTIONn = 39
Phase 13Phase 1 / 21Phase 27Phase 2 / 31Phase 314Phase 413

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

EEG Biomarkers for Pediatric ADHD Treatment Stratification

Not yet recruitingPH IVBoston Children's Hospitaln=2202031

USE of JORNAY PM® to TREAT ADHD in PEDIATRIC EPILEPSY

RecruitingPH IVHugo W. Moser Research Institute at Kennedy Krieger, Inc.n=252030

Effectiveness of Methylphenidate in Children and Adolescents With KBG Syndrome: An N-of-1 Series

RecruitingPH IVRadboud University Medical Centern=152027

Attention Management Trial for Children With FASD - a N-of-1 Control Trial of Prescribed Stimulants for ADHD in FASD

Unknown statusPH IVMonash Medical Centren=202023

A Phase IV, Real World, Open-label, Multi-centre Study on the Use of FOQUEST® (Methylphenidate Hydrochloride Controlled-release Capsules) for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Pediatric and Adult Patients

CompletedPH IVPurdue Pharma, Canadan=2572021

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase II Proof-of-concept Trial of Methylphenidate in Children With Apraxia of Speech: a Double-blind, Randomised, Placebo-controlled, Cross-over Trial

CompletedPH IIMurdoch Childrens Research Instituten=182025

A Phase IV, Real World, Open-label, Multi-centre Study on the Use of FOQUEST® (Methylphenidate Hydrochloride Controlled-release Capsules) for the Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in Pediatric and Adult Patients

CompletedPH IVPurdue Pharma, Canadan=2572021

Active Emergence of From Isoflurane General Anesthesia Induced by Methylphenidate

CompletedPH INicoleta Stoicean=542018

The Effect of Ritalin (Methylphenidate Hydrochloride) on Pain and Auditory Sensitivity: an Exploratory Double-blind Randomized Controlled Trial on Healthy Subjects

CompletedPH IIRambam Health Care Campusn=412014

A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Forced-dose Titration, Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

CompletedPH IVShiren=5492014

A Phase 4, Randomized, Double-blind, Multicenter, Parallel-group, Active-controlled, Dose-optimization Safety and Efficacy Study of SPD489 (VYVANSE®) Compared With OROS-MPH (CONCERTA®) With a Placebo Reference Arm, in Adolescents Aged 13-17 Years With Attention-deficit/Hyperactivity Disorder (ADHD)

CompletedPH IVShiren=4642014

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102014
Journals, researchers & institutions
Top journals
  • European child & adolescent psychiatry1
  • European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology1
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
Leading researchers
  • Banaschewski T2
  • Civil R2
  • Lecendreux M2
  • Zuddas A2
  • Ali A1
  • Anderson C1
  • Atherton PJ1
  • Barton D1
Leading institutions
free-text, unnormalised
  • Mayo Clinic1
  • Ninewells Hospital1
  • Ninewells Hospital and Medical School1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.