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Drug

Methylphenidate

Approved · FDA
Emerging researchLate-stage developmentRising momentum
Also known as Aptensio, Concerta, Cotempla, Daytrana+15 more

Aptensio, Concerta, Cotempla, Daytrana, Jornay, MPH, Metadate, Methylin, Metilfenidato, QuilliChew, Quillivant, Quillivant XR, Relexxii, Ritalin, Methylphenidan, Methyl phenidylacetate, Methylphenidate Hydrochloride, Methylphenidatum, methyl phenyl(piperidin-2-yl)acetate.

RxNorm6901ChEMBLCHEMBL290634UNII207ZZ9QZ49
10
Research papers
28
Active clinical trials
6
Regulatory events
Latest activity
beta

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

Psilocybin and Affective Function in Chronic Lower Back Pain Depression

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

Label change: METHYLPHENIDATE (ANDA206497)

Regulatory2026-07-22FDA

Label change: METHYLPHENIDATE (ANDA206497)

Regulatory2026-07-22FDA

Orexin's Role in The Neurobiology of Substance Use Disorder

Clinical trial2026-07-07Results expected Q4 2027 · ClinicalTrials.gov

Randomized Placebo-Controlled Trial of Methylphenidate for the Treatment of Post-Traumatic Stress Disorder With Associated Neurocognitive Complaints

Clinical trial2026-07-06Primary completion · ClinicalTrials.gov

Effect of Methylphenidate on Cancer-related Fatigue in Patients Treated for a Brain Tumor During Childhood or Adolescence: Protocol for a Randomized, Double-blind, Placebo-controlled Crossover Trial - the EMBRAIN Trial

Clinical trial2026-06-26Results expected Q4 2029 · ClinicalTrials.gov

Label change: METHYLPHENIDATE (ANDA206497)

Regulatory2024-08-30FDA

Methylphenidate and Short-Term Cardiovascular Risk.

Research2024-03-04JAMA network open

Brain connectivity changes to fast versus slow dopamine increases.

Research2024-02-07Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology

Examining the role of dopamine in methylphenidate's effects on resting brain function.

Research2023-12-18Proceedings of the National Academy of Sciences of the United States of America

Neural circuit selective for fast but not slow dopamine increases in drug reward.

Research2023-11-08Nature communications

Approval: METHYLPHENIDATE (ANDA206497)

Regulatory2022-03-14FDA

Profile

Identifiers & mechanism

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

Canonical name
Methylphenidate
Aliases & brands
AptensioConcertaCotemplaDaytranaJornayMPHMetadateMethylinMetilfenidatoQuilliChewQuillivantQuillivant XRRelexxiiRitalinMethylphenidanMethyl phenidylacetateMethylphenidate HydrochlorideMethylphenidatummethyl phenyl(piperidin-2-yl)acetate
RxNorm CUI
6901
ChEMBL ID
CHEMBL290634
UNII
207ZZ9QZ49
Regulatory jurisdictions
mhrafda

Regulatory timeline

6 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
2022-03-14
Latest approval
2022-03-14
Authorities
FDA · MHRA
Total events
6
fdaU.S. Food and Drug Administration· 4 events
2026-07-22Label change
Label change: METHYLPHENIDATE (ANDA206497)
Evidence ↗
2026-07-22Label change
Label change: METHYLPHENIDATE (ANDA206497)
Evidence ↗
2024-08-30Label change
Label change: METHYLPHENIDATE (ANDA206497)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Methylphenidate: new patient information
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Methylphenidate: safe and effective use to treat ADHD
Evidence ↗

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

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

192 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
192
registered trials across all phases
LATEST COMPLETION 2026
28
Active studies
23
Recruiting
134
Late-stage (III+)
118
Completed
46
Discontinued
PHASE DISTRIBUTIONn = 192
Early Phase 17Phase 123Phase 1 / 26Phase 222Phase 2 / 310Phase 321Phase 463Phase N / A40

Late-stage studies

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

Comparing Medication Treatments for Neurodevelopmental Differences in Young Children on Rates of Beneficial Response

Not yet recruitingPH IVChildren's Hospital Medical Center, Cincinnatin=3702030

Precision Care for Major Depressive Disorder

Enrolling by invitationPH IVUniversity of California, San Franciscon=1502029

Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Patients With ADHD

RecruitingPH IVJohns Hopkins Universityn=302029

Multimodal Brain Imaging of the Neural Effects of Methylphenidate in Children and Adolescents With ADHD

WithdrawnPH IVJohns Hopkins University2029

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits: a Randomized, Double-blind, Placebo-controlled Trial

RecruitingPH IVVA Office of Research and Developmentn=2262028

Recent completions

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

A Phase 1, Single Blind, Parallel-arm Trial to Assess the Potential for Pharmacodynamic Interaction of Centanafadine When Co-administered With Stimulants in Healthy Adults

CompletedPH IOtsuka Pharmaceutical Development & Commercialization, Inc.n=402026

TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study

CompletedPH IHubert Fernandezn=232025

Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans

CompletedPH IUniversity of Zurichn=1222025

A Randomized Placebo-controlled Trial of Methylphenidate in Veterans With a Diagnosis of Post Traumatic Stress Disorder and Recent Cerebral Stroke

CompletedPH I/IIVA Office of Research and Developmentn=202025

The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics

CompletedPH IINorthwestern Universityn=402024

Dopaminergic Modulation of Brain Activation Using Simultaneous PET/Pharmacological MRI

CompletedPH INational Institute on Alcohol Abuse and Alcoholism (NIAAA)n=252024

Research activity

10 papers

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

Publications over time
19992024
Most influential

Behavioral and electrophysiologic predictors of treatment response to stimulants in children with attention disorders.

Journal of child neurology · 1999 · 88 cites

Methylphenidate for apathy and functional status in dementia of the Alzheimer type.

The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry · 2010 · 62 cites

Methylphenidate and Short-Term Cardiovascular Risk.

JAMA network open · 2024 · 20 cites

Neural circuit selective for fast but not slow dopamine increases in drug reward.

Nature communications · 2023 · 14 cites

Examining the role of dopamine in methylphenidate's effects on resting brain function.

Proceedings of the National Academy of Sciences of the United States of America · 2023 · 12 cites

Time-varying SUVr reflects the dynamics of dopamine increases during methylphenidate challenges in humans.

Communications biology · 2023 · 11 cites
Recent papers

Methylphenidate and Short-Term Cardiovascular Risk.

JAMA network open · 2024 · 20 cites

Brain connectivity changes to fast versus slow dopamine increases.

Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024 · 9 cites

Neural circuit selective for fast but not slow dopamine increases in drug reward.

Nature communications · 2023 · 14 cites

Examining the role of dopamine in methylphenidate's effects on resting brain function.

Proceedings of the National Academy of Sciences of the United States of America · 2023 · 12 cites

Time-varying SUVr reflects the dynamics of dopamine increases during methylphenidate challenges in humans.

Communications biology · 2023 · 11 cites

Effect of transdermal methylphenidate wear times on sleep in children with attention deficit hyperactivity disorder.

Pediatric neurology · 2011 · 10 cites
Major research themes8
Methylphenidate5Brain2Dopamine2Attention Deficit Disorder with Hyperactivity1Behavior, Addictive1Cardiovascular Diseases1Magnetic Resonance Imaging1Positron-Emission Tomography1
Journals, researchers & institutions
Top journals
  • Communications biology1
  • JAMA network open1
  • Journal of child neurology1
  • Journal of negative results in biomedicine1
  • Nature communications1
  • Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology1
Leading researchers
  • Manza P4
  • Tomasi D4
  • Volkow ND4
  • Wang GJ4
  • Yonga MV4
  • Biesecker C3
  • Dennis E3
  • Johnson A3
Leading institutions
free-text, unnormalised
  • National Institute on Alcohol Abuse and Alcoholism3
  • Clinical Center2
  • School of Life Science and Technology2
  • Brain Research Laboratories1
  • Center for Biomedical Imaging1
  • Clinical and Experimental Sciences (CNS and Psychiatry)1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.