methylphenidate
Trade name: ritalin
Approved
Dec 5, 1955
Methylphenidate is a CNS stimulant approved for the treatment of narcolepsy and attention deficit hyperactivity disorder. The drug is believed to bind the dopamine transporter in the presynaptic cell membrane, thereby blocking the reuptake of dopamine and causing an increase in extracellular dopamine levels. — NCATS
Clinical trial activity
416 trials · 263 clinical orgs · 61 marketing orgs
Earliest trial started Feb 1, 1986 (NCT00693212)
Timeline
1950s
1970s
- Dec 23, 1977
Lannett Company, Inc. — NDA Secondary Org
- Dec 23, 1977
Lannett Company, Inc. — Marketing Organization
1980s
- Jan 1, 1986
Earliest Phase 3 Sponsor(trial)
1990s
- Jan 1, 1997
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1997
Earliest Phase 2 Sponsor(trial)
- Nov 27, 1998
Specgx Llc — NDA Secondary Org
- Nov 27, 1998
Specgx Llc — Marketing Organization
2000s
- Aug 1, 2000
Johnson and Johnson — NDA Secondary Org
- Feb 9, 2001
Watson Pharmaceuticals — Marketing Organization
- Mar 29, 2001
Able Laboratories — Marketing Organization
- Apr 3, 2001
AYTU BioScience — Marketing Organization
- Apr 3, 2001
AYTU BioScience — NDA Secondary Org
- Dec 21, 2001
Actavis — Marketing Organization
- Dec 21, 2001
Heritage Pharma — Marketing Organization
- Apr 6, 2006
Noven Therapeutics — NDA Secondary Org
2010s
- Jul 23, 2010
Tris Pharma, Inc. — Marketing Organization
- Dec 1, 2011
Mayne Pharma — Marketing Organization
- Mar 15, 2012
Sun Pharmaceuticals — Marketing Organization
- Jul 13, 2012
Barr Laboratories — Marketing Organization
- Sep 27, 2012
NextWave Pharmaceuticals — NDA Secondary Org
- Sep 27, 2012
Pfizer — NDA Secondary Org
- Nov 12, 2013
Esteve Labs — Marketing Organization
- Nov 12, 2013
Allied Pharmaceutical Services — Marketing Organization
- Mar 12, 2014
Rocky Mountain Labs — Marketing Organization
- Sep 23, 2014
Oxford Pharmaceuticals — Marketing Organization
- Feb 25, 2015
Novel Anti-Infective Technologies, LLC — Marketing Organization
- Apr 17, 2015
Rhodes Pharmaceuticals, L.P. — NDA Secondary Org
- Jun 9, 2015
Abhai LLC — Marketing Organization
- Sep 22, 2015
Ascent Pharmahealth — Marketing Organization
- Sep 22, 2015
Allergan PLC (2015) — Marketing Organization
- Feb 29, 2016
County Line — Marketing Organization
- Jul 28, 2016
Impax Laboratories — Marketing Organization
- Oct 21, 2016
Mylan — Marketing Organization
- Nov 7, 2016
Rising Pharmaceuticals — Marketing Organization
- Mar 3, 2017
Nostrum Laboratories — Marketing Organization
- Jun 19, 2017
Neos Therapeutics, Inc — NDA Secondary Org
- Jul 14, 2017
Ani Pharmaceuticals — Marketing Organization
- Jul 28, 2017
Osmotica Pharmaceutical — Marketing Organization
- Feb 1, 2018
Amneal Pharmaceuticals — Marketing Organization
- Mar 2, 2018
Bionpharma Inc — Marketing Organization
- Mar 2, 2018
US Pharma — Marketing Organization
- Aug 8, 2018
Ironshore Pharmaceuticals and Development, Inc — NDA Secondary Org
- Oct 3, 2018
Wes Pharma Inc — Marketing Organization
- Oct 3, 2018
Novelgenix Therapeutics — Marketing Organization
- Oct 3, 2018
Eywa Pharma — Marketing Organization
- Oct 25, 2018
Aurobindo Pharma — Marketing Organization
- Nov 21, 2018
Granules India — Marketing Organization
- Nov 30, 2018
Alvogen — Marketing Organization
- Dec 20, 2018
Teva — Marketing Organization
- Feb 1, 2019
Cediprof Inc — Marketing Organization
- Feb 27, 2019
Purdue Pharmaceuticals — NDA Secondary Org
- Apr 24, 2019
Andor Pharms — Marketing Organization
- Jul 15, 2019
Strides Pharma Science — Marketing Organization
- Jul 15, 2019
Par Pharmaceuticals — Marketing Organization
- Sep 3, 2019
AbbVie — Marketing Organization
- Oct 4, 2019
Alkem Labs Ltd — Marketing Organization
2020s
- Apr 10, 2020
Patrin Pharma Inc — Marketing Organization
- Apr 10, 2020
ANDA Repository — Marketing Organization
- Jun 4, 2020
Quagen Pharma — Marketing Organization
- Jul 23, 2020
Prinston Inc — Marketing Organization
- Jul 29, 2020
Dr. Reddy's Laboratories — Marketing Organization
- Oct 28, 2020
Accord Research — Marketing Organization
- Dec 16, 2020
Chartwell Pharmaceuticals — Marketing Organization
- May 31, 2022
Rhodes Pharmaceuticals, L.P. — Marketing Organization
- Jun 23, 2022
Osmotica Pharmaceutical — NDA Secondary Org
- Jan 6, 2023
MSN Laboratories — Marketing Organization
Indications
Studied for
- Accidental Falls · Phase 4
- Agoraphobia · Phase 4
- AIDS Dementia Complex · Phase 3
- Alcoholism · Phase 4
- Alzheimer Disease · Phase 4
- Anemia, Sickle Cell · Phase 3
- Anesthesia · Phase 1/Phase 2
- Anesthesia, General · Phase 1/Phase 2
- Anxiety · Phase 2/Phase 3
- Anxiety Disorders · Phase 4
- Apathy · Phase 4
- Apraxias · Phase 2
- Asthenia · Phase 3
- Attention Deficit and Disruptive Behavior Disorders · Phase 4
- Autism Spectrum Disorder · Phase 4
- Autistic Disorder · Phase 4
- Back Pain · Phase 1
- Behavior, Addictive · Phase 1/Phase 2
- Binge-Eating Disorder · Phase 2
- Bipolar Disorder · Phase 4
- Bone Diseases, Developmental · Phase 4
- Borderline Personality Disorder · Early Phase 1
- Brain Injuries · Phase 4
- Brain Injuries, Traumatic · Phase 4
- Brain Neoplasms · Phase 4
- Breast Neoplasms · Phase 3
- Carboxylesterase · Phase 4
- Central Nervous System Stimulants · Phase 4
- Cerebral Palsy · Early Phase 1
- Child, Preschool · Phase 4
- Chronic Pain · Phase 2
- Cocaine-Related Disorders · Phase 4
- Cognition · Phase 4
- Cognition Disorders · Phase 4
- Cognitive Dysfunction · Phase 4
- Coma · Phase 1
- Conduct Disorder · Phase 4
- Consciousness Disorders · Phase 1
- Deficiency Diseases · Phase 4
- Delayed Emergence from Anesthesia · Phase 1
- Delirium · Phase 3
- Dementia · Phase 4
- Dementia, Vascular · Phase 2/Phase 3
- Depression · Phase 4
- Diabetes Mellitus · Phase 4
- DiGeorge Syndrome · Phase 4
- Down Syndrome · Phase 1/Phase 2
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Epilepsy · Phase 4
- Esterases · Phase 4
- Executive Function · Phase 4
- Exercise Test · Phase 4
- Fatigue · Phase 3
- Fetal Alcohol Spectrum Disorders · Phase 4
- Fragile X Syndrome · Phase 4
- Gait · Phase 4
- Gait Disorders, Neurologic · Phase 4
- Gastrointestinal Neoplasms · Phase 3
- Growth · Phase 4
- Healthy Volunteers · Phase 4
- Hoarding Disorder · Phase 2
- Hypotension, Orthostatic · Phase 1
- Hypothermia · Phase 4
- Impulsive Behavior · Early Phase 1
- Intellectual Disability · Phase 1
- Irritable Mood · Phase 4
- Lymphoma · Phase 2
- Major Depressive Disorder · Phase 4
- Mania · Phase 3
- Methamphetamine · Phase 2
- Methylphenidate · Phase 3
- Mood Disorders · Phase 2
- Motivation · Early Phase 1
- Multiple Sclerosis · Phase 3
- Multiple Sclerosis, Chronic Progressive · Phase 1
- Multiple Sclerosis, Relapsing-Remitting · Phase 1
- Myotonic Dystrophy · Phase 2/Phase 3
- Naltrexone · Phase 1
- Neoplasm Metastasis · Phase 3
- Neoplasms · Phase 3
- Neurodevelopmental Disorders · Phase 4
- Neurofibromatosis 1 · Phase 4
- Obesity · Phase 3
- Obsessive-Compulsive Disorder · Phase 4
- Opioid-Related Disorders · Phase 2/Phase 3
- Pain · Phase 2
- Panic Disorder · Phase 4
- Parkinson Disease · Phase 4
- Pharmacokinetics · Phase 1
- Pharmacology · Phase 2
- Phobia, Social · Phase 4
- Physiology · Phase 1
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 4
- Problem Behavior · Phase 4
- Prostatic Neoplasms · Phase 2/Phase 3
- Psilocybin · Early Phase 1
- Psychological Distress · Phase 1
- Pure Autonomic Failure · Phase 1
- Quality of Life · Phase 3
- Reading · Phase 4
- Sleep · Phase 2/Phase 3
- Sleep Disorders, Intrinsic · Phase 4
- Sleep Wake Disorders · Phase 2
- Smoking · Phase 3
- Social Cognition · Early Phase 1
- Stress Disorders, Post-Traumatic · Phase 4
- Stroke · Phase 4
- Substance Abuse, Oral · Phase 1/Phase 2
- Substance-Related Disorders · Phase 4
- Tobacco Use Disorder · Phase 1
- Trichotillomania · Phase 4
- Williams Syndrome · Phase 4
Mechanism of action
- Dopamine transporterINHIBITOR
SLC6A3 inhibitor
- Norepinephrine transporterINHIBITOR
SLC6A2 inhibitor
Approval history
- approvedDec 5, 1955
Chemistry & pharmacology
SMILES
COC(=O)C(c1ccccc1)C1CCCCN1- Mol. weight
- 233.31 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
Yes
Sources
- ChEMBLCHEMBL796 ↗
- WikipediaMethylphenidate ↗
- NCATS207ZZ9QZ49 ↗
- ChEMBLCHEMBL1722 ↗
Also known as
- 5,10-dihydro-5-methylphenazine
- 5,10-dihydro-5-methylphenazine, radical ion (+)
- alpha-phenyl-2-piperidineacetic acid methyl ester
- alpha-phenyl-2-piperidineacetic acid methyl ester
- calocain
- concerta
- concerta
- concerta
- concerta
- daytrana
- daytrana
- delmosart
- equasym
- equasym
- equasym xl
- equasym xl
- hld200
- jns001
- matoride xl
- medikinet
- medikinet
- medikinet xl
- metadate cd
- metadate cd
- metadate er
- metadate er
- methelphenidate
- methyl alpha-phenyl-alpha-2-piperidinylacetate
- methyl alpha-phenyl-alpha-2-piperidinylacetate
- methyl alpha-phenyl-alpha-(2-piperidyl)acetate
- methyl alpha-phenyl-alpha-(2-piperidyl)acetate
- methylin
- methylin
- methylin er
- methylin er
- methylphenidan
- methylphenidan
- methylphenidan
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate
- methylphenidate hcl
- methylphenidate hcl
- methylphenidate hcl
- methylphenidate hydrochloride
- methylphenidate hydrochloride
- methylphenidate hydrochloride
- methylphenidate hydrochloride
- methylphenidate hydrochloride
- methylphenidatum
- methylphenidatum
- methyl phenidylacetate
- methyl phenidylacetate
- metilfenidato
- metilfenidato
- mph
- mph
- mph
- nt0102
- nwp09
- phenidylate
- quillivant xr
- quillivant xr
- ritalin
- ritalin
- ritalin
- ritalin
- ritalin la
- ritalin la
- ritalin sr
- ritalin sr
- tranquilyn
- xenidate xl
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07306078 | Early Phase 1 (Phase 1) | May 31, 2026 | University of Florida |
| NCT06977308 | Phase 1 | Mar 1, 2026 | Columbia University, National Institute of Mental Health (NIMH), Stony Brook University |
| NCT07300956 | Phase 4 | Feb 28, 2026 | Harvard University, Patient-Centered Outcomes Research Institute, Stanford University, University of Cincinnati, University of Kansas, University of Pennsylvania |
| NCT07279740 | Phase 2 | Jan 31, 2026 | Alzheimer Society of Canada, Brain Canada, University of Toronto |
| NCT07301632 | Phase 2 | Dec 17, 2025 | Unity Health Toronto |
| NCT07226219 | Phase 1 | Nov 25, 2025 | St. Jude Children's Hospital |
| NCT07043452 | Early Phase 1 (Phase 1) | Nov 15, 2025 | Johns Hopkins University |
| NCT07086313 | Phase 2/Phase 3 (Phase 3) | Aug 31, 2025 | Otsuka |
| NCT07087327 | Phase 3 | Aug 31, 2025 | Otsuka |
| NCT06905587 | Phase 3 | Jun 30, 2025 | Aalborg University, Aarhus University, University of Copenhagen, University of Southern Denmark |
| NCT06759298 | Early Phase 1 (Phase 1) | Jan 15, 2025 | Tanta University |
| NCT06580041 | Phase 4 | Nov 12, 2024 | University of California, San Francisco |
| NCT06431256 | Phase 3 | Sep 13, 2024 | Collegium Pharmaceutical, Inc., Ironshore Pharmaceuticals and Development, Inc |
| NCT06465641 | Phase 4 | Sep 1, 2024 | Radboud University |
| NCT07253441 | Phase 1 | Aug 29, 2024 | Otsuka |
| NCT06577779 | Phase 4 | Aug 19, 2024 | New York University |
| NCT06355414 | Phase 1 | Apr 22, 2024 | Johns Hopkins University, National Center for Complementary and Integrative Health (NCCIH) |
| NCT05761756 | N/A | Feb 29, 2024 | Duke University |
| NCT05669170 | Phase 2 | Jan 31, 2024 | Department of Veteran Affairs |
| NCT06077669 | Phase 4 | Jan 20, 2024 | Johns Hopkins University |
Organizations
Research & Development (263)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Harvard University | Academic/Hospital | 33 | 30 | 5 | 2002 |
| Johnson and Johnson | For profit | 29 | 20 | 4 | 2003 |
| National Institute of Mental Health (NIMH) | Government | 26 | 7 | 5 | 1986 |
| University of Cincinnati | Academic/Hospital | 19 | 14 | 4 | 1997 |
| National Institute on Drug Abuse (NIDA) | Government | 18 | 6 | 4 | 1997 |
| Tel Aviv University | Academic/Hospital | 17 | 16 | 3 | 2001 |
| McNeil | For profit | 14 | 4 | 2 | 2002 |
| University of Texas at Houston | Academic/Hospital | 13 | 13 | 5 | 2002 |
| Purdue Pharmaceuticals | For profit | 12 | 5 | 3 | 2014 |
| Department of Veteran Affairs | Government | 10 | 9 | 4 | 2005 |
| Janssen Pharmaceutica NV | For profit | 10 | 0 | 3 | 2005 |
| Rhodes Pharmaceuticals, L.P. | For profit | 10 | 10 | 2 | 2010 |
| Duke University | Academic/Hospital | 9 | 5 | 4 | 2006 |
| Shire | For profit | 9 | 6 | 5 | 2004 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 8 | 5 | 4 | 2001 |
| Johns Hopkins University | Academic/Hospital | 8 | 7 | 4 | 2007 |
| National Cancer Institute (NCI) | Government | 8 | 1 | 3 | 1999 |
| Noven Therapeutics | For profit | 8 | 8 | 3 | 2004 |
| Columbia University | Academic/Hospital | 7 | 6 | 4 | 1998 |
| National Institute of Neurological Disorders and Stroke (NINDS) | Government | 7 | 1 | 3 | 1999 |
Marketing (83)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ANDA Repository | For profit | MKTG | Apr 10, 2020 |
| AYTU BioScience | For profit | MKTG | Apr 3, 2001 |
| AYTU BioScience | For profit | NDA2 | Apr 3, 2001 |
| AbbVie | For profit | MKTG | Sep 3, 2019 |
| Abhai LLC | For profit | SYN | May 11, 2017 |
| Abhai LLC | For profit | MKTG | Jun 9, 2015 |
| Able Laboratories | For profit | MKTG | Mar 29, 2001 |
| Accord Research | For profit | MKTG | Oct 28, 2020 |
| Actavis | For profit | MKTG | Dec 21, 2001 |
| Actavis | For profit | SYN | Mar 21, 2018 |
| Actavis | For profit | SYN | Aug 29, 1997 |
| Alkem Labs Ltd | For profit | MKTG | Oct 4, 2019 |
| Allergan PLC (2015) | For profit | MKTG | Sep 22, 2015 |
| Allied Pharmaceutical Services | For profit | MKTG | Nov 12, 2013 |
| Alvogen | For profit | MKTG | Nov 30, 2018 |
| Alvogen | For profit | SYN | Feb 29, 2016 |
| Amneal Pharmaceuticals | For profit | MKTG | Feb 1, 2018 |
| Andor Pharms | For profit | MKTG | Apr 24, 2019 |
| Ani Pharmaceuticals | For profit | SYN | Jul 14, 2017 |
| Ani Pharmaceuticals | For profit | MKTG | Jul 14, 2017 |
| Ascent Pharmahealth | For profit | MKTG | Sep 22, 2015 |
| Aurobindo Pharma | For profit | MKTG | Oct 25, 2018 |
| Barr Laboratories | For profit | MKTG | Jul 13, 2012 |
| Bionpharma Inc | For profit | MKTG | Mar 2, 2018 |
| Bionpharma Inc | For profit | SYN | Mar 2, 2018 |
| Cediprof Inc | For profit | MKTG | Feb 1, 2019 |
| Chartwell Pharmaceuticals | For profit | MKTG | Dec 16, 2020 |
| Ciba | For profit | NDA | Dec 5, 1955 |
| County Line | For profit | MKTG | Feb 29, 2016 |
| Dr. Reddy's Laboratories | For profit | MKTG | Jul 29, 2020 |
| Dr. Reddy's Laboratories | For profit | SYN | Dec 1, 2011 |
| Esteve Labs | For profit | MKTG | Nov 12, 2013 |
| Esteve Labs | For profit | SYN | Nov 12, 2013 |
| Eywa Pharma | For profit | MKTG | Oct 3, 2018 |
| Granules India | For profit | SYN | Nov 21, 2018 |
| Granules India | For profit | MKTG | Nov 21, 2018 |
| Heritage Pharma | For profit | MKTG | Dec 21, 2001 |
| Impax Laboratories | For profit | MKTG | Jul 28, 2016 |
| Ironshore Pharmaceuticals and Development, Inc | For profit | NDA2 | Aug 8, 2018 |
| Johnson and Johnson | For profit | NDA2 | Aug 1, 2000 |
| Lannett Company, Inc. | For profit | NDA2 | Dec 23, 1977 |
| Lannett Company, Inc. | For profit | MKTG | Dec 23, 1977 |
| MSN Laboratories | For profit | MKTG | Jan 6, 2023 |
| Mayne Pharma | For profit | MKTG | Dec 1, 2011 |
| Mylan | For profit | MKTG | Oct 21, 2016 |
| Mylan | For profit | SYN | Oct 21, 2016 |
| Mylan | For profit | SYN | Mar 14, 2022 |
| Neos Therapeutics, Inc | For profit | NDA2 | Jun 19, 2017 |
| NextWave Pharmaceuticals | For profit | NDA2 | Sep 27, 2012 |
| NextWave Pharmaceuticals | For profit | SYN | Dec 4, 2015 |
| Nostrum Laboratories | For profit | MKTG | Mar 3, 2017 |
| Novartis | For profit | NDA2 | Dec 5, 1955 |
| Novel Anti-Infective Technologies, LLC | For profit | MKTG | Feb 25, 2015 |
| Novelgenix Therapeutics | For profit | MKTG | Oct 3, 2018 |
| Noven Therapeutics | For profit | NDA2 | Apr 6, 2006 |
| Osmotica Pharmaceutical | For profit | MKTG | Jul 28, 2017 |
| Osmotica Pharmaceutical | For profit | SYN | Jun 23, 2022 |
| Osmotica Pharmaceutical | For profit | NDA2 | Jun 23, 2022 |
| Oxford Pharmaceuticals | For profit | MKTG | Sep 23, 2014 |
| Par Pharmaceuticals | For profit | MKTG | Jul 15, 2019 |
| Patrin Pharma Inc | For profit | MKTG | Apr 10, 2020 |
| Patrin Pharma Inc | For profit | SYN | Apr 10, 2020 |
| Pfizer | For profit | NDA2 | Sep 27, 2012 |
| Prinston Inc | For profit | MKTG | Jul 23, 2020 |
| Purdue Pharmaceuticals | For profit | NDA2 | Feb 27, 2019 |
| Quagen Pharma | For profit | MKTG | Jun 4, 2020 |
| Rhodes Pharmaceuticals, L.P. | For profit | NDA2 | Apr 17, 2015 |
| Rhodes Pharmaceuticals, L.P. | For profit | MKTG | May 31, 2022 |
| Rising Pharmaceuticals | For profit | SYN | Nov 7, 2016 |
| Rising Pharmaceuticals | For profit | MKTG | Nov 7, 2016 |
| Rocky Mountain Labs | Academic/Hospital | MKTG | Mar 12, 2014 |
| Sandoz | For profit | MKTG | Dec 5, 1955 |
| Specgx Llc | For profit | NDA2 | Nov 27, 1998 |
| Specgx Llc | For profit | MKTG | Nov 27, 1998 |
| Strides Pharma Science | For profit | MKTG | Jul 15, 2019 |
| Sun Pharmaceuticals | For profit | MKTG | Mar 15, 2012 |
| Teva | For profit | SYN | Jul 19, 2012 |
| Teva | For profit | MKTG | Dec 20, 2018 |
| Teva | For profit | SYN | Feb 7, 2023 |
| Tris Pharma, Inc. | For profit | MKTG | Jul 23, 2010 |
| US Pharma | For profit | MKTG | Mar 2, 2018 |
| Watson Pharmaceuticals | For profit | MKTG | Feb 9, 2001 |
| Wes Pharma Inc | For profit | MKTG | Oct 3, 2018 |