modafinil
Trade name: provigil
Small moleculeapprovedOrphan Drug FDA
Approved
Dec 24, 1998
Modafinil, sold under the brand name Provigil among others, is a central nervous system (CNS) stimulant and eugeroic medication used primarily to treat narcolepsy, a sleep disorder characterized by excessive daytime sleepiness and sudden sleep attacks. Modafinil is also approved for stimulating wakefulness in people with sleep apnea and shift work sleep disorder. It is taken by mouth. Modafinil is not approved by the US Food and Drug Administration (FDA) for use in people under 17 years old. — Wikipedia
Clinical trial activity
166 trials · 134 clinical orgs · 21 marketing orgs
Phase 1
36
Phase 2
89
Phase 3
34
Phase 4
20
Earliest trial started Apr 1, 1997 (NCT00262470)
Timeline
1990s
2000s
- Jan 1, 2002
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Jan 7, 2004
Barr Laboratories — Marketing Organization
- Dec 16, 2005
Teva — Marketing Organization
- Dec 29, 2006
Sandoz — Marketing Organization
- Dec 29, 2006
Novartis — Marketing Organization
- Jul 18, 2007
Caraco Pharmaceutical Laboratories — Marketing Organization
- Jul 18, 2007
Sun Pharmaceuticals — Marketing Organization
2010s
- Jul 16, 2012
Mylan — Marketing Organization
- Jul 16, 2012
Natco Pharma — Marketing Organization
- Sep 26, 2012
Orbion Pharms — Marketing Organization
- Sep 26, 2012
Hikma — Marketing Organization
- Sep 26, 2012
Orchid Pharma — Marketing Organization
- Sep 27, 2012
Aurobindo Pharma — Marketing Organization
- Oct 18, 2012
Alembic — Marketing Organization
- Nov 1, 2012
Watson Pharmaceuticals — Marketing Organization
- Nov 1, 2012
Actavis — Marketing Organization
- Feb 3, 2014
Apotex — Marketing Organization
- Aug 16, 2017
Heritage Pharma — Marketing Organization
- Aug 16, 2017
Appco Pharma — Marketing Organization
- Sep 14, 2017
Zydus Discovery DMCC — Marketing Organization
- Sep 14, 2017
Cadila Healthcare — Marketing Organization
Indications
Studied for
- Adult · Phase 4
- Alcoholism · Phase 2
- Alcohol-Related Disorders · Phase 2
- Alzheimer Disease · Phase 4
- Amphetamine-Related Disorders · Phase 2
- Apathy · Phase 3
- Apnea · Phase 2
- Attention · Phase 4
- Attention Deficit Disorder with Hyperactivity · Phase 3
- Back Pain · Phase 1/Phase 2
- Bipolar Disorder · Phase 4
- Body Fluids · Early Phase 1
- Brain Injuries · Phase 1/Phase 2
- Brain Neoplasms · Phase 3
- Breast Neoplasms · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 4
- Cataplexy · Phase 3
- Cerebral Palsy · Early Phase 1
- Cocaine-Related Disorders · Phase 3
- Cognition · Phase 3
- Cognition Disorders · Phase 3
- Cognitive Dysfunction · Phase 3
- Colonic Neoplasms · Phase 2
- COVID-19 · Phase 2
- Deglutition Disorders · Phase 2
- Delayed Emergence from Anesthesia · Phase 4
- Delirium · Phase 3
- Depression · Phase 4
- Disorders of Excessive Somnolence · Phase 3
- Drug Administration Schedule · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drug Therapy · Phase 2
- Endometrial Neoplasms · Phase 2
- Executive Function · Phase 4
- Exercise · Phase 3
- Fallopian Tube Neoplasms · Phase 2
- Fatigue · Phase 4
- Genital Neoplasms, Female · Phase 2
- Hamartoma · Phase 2
- Healthy Volunteers · Phase 4
- HIV Infections · Phase 4
- Hypotension, Orthostatic · Phase 1
- Idiopathic Hypersomnia · Phase 2
- Infusions, Intravenous · Phase 1
- Liver Cirrhosis, Biliary · Phase 1
- Liver Neoplasms · Phase 1
- Lung Neoplasms · Phase 2
- Major Depressive Disorder · Phase 3
- Melanoma · Phase 2
- Memory, Short-Term · Phase 4
- Mental Health · Phase 4
- Methamphetamine · Phase 4
- Modafinil · Phase 3
- Mood Disorders · Early Phase 1
- Multiple Sclerosis · Phase 4
- Narcolepsy · Phase 3
- Neoplasms · Phase 3
- Neoplasms, Bone Tissue · Phase 3
- Neoplasms by Histologic Type · Phase 3
- Neoplasms, Connective and Soft Tissue · Phase 3
- Neoplasms, Connective Tissue · Phase 3
- Neurobehavioral Manifestations · Phase 1
- Neurodevelopmental Disorders · Early Phase 1
- Opioid-Related Disorders · Phase 2
- Orthostatic Intolerance · Phase 1/Phase 2
- Osteoarthritis · Phase 4
- Ovarian Neoplasms · Phase 3
- Pain · Phase 3
- Parkinson Disease · Phase 2
- Postoperative Cognitive Complications · Phase 2
- Postpoliomyelitis Syndrome · Phase 3
- Postural Orthostatic Tachycardia Syndrome · Early Phase 1
- Prostatic Neoplasms · Phase 3
- Psychotic Disorders · Phase 4
- Pure Autonomic Failure · Phase 1
- Quality of Life · Phase 3
- Rare Diseases · Phase 3
- Respiratory Insufficiency · Phase 3
- Sarcoma · Phase 3
- Sarcoma, Ewing · Phase 3
- Schizophrenia · Phase 4
- Sleep Apnea, Obstructive · Phase 4
- Sleep Apnea Syndromes · Phase 1
- Sleep Deprivation · Phase 1
- Sleep Disorders, Circadian Rhythm · Phase 3
- Sleep Disorders, Intrinsic · Phase 3
- Sleep Initiation and Maintenance Disorders · Phase 4
- Sleep Wake Disorders · Phase 3
- Spatial Processing · Phase 2
- Stress Disorders, Post-Traumatic · Phase 2/Phase 3
- Stroke · Phase 3
- Substance-Related Disorders · Phase 2
- Tachycardia · Phase 1/Phase 2
- Tinnitus · Phase 1
- Tobacco Use Disorder · Phase 1
- Uterine Cervical Neoplasms · Phase 2
- Uterine Neoplasms · Phase 2
Mechanism of action
- Dopamine transporterBINDING AGENT
SLC6A3 binding agent
- Dopamine transporterINHIBITOR
SLC6A3 inhibitor
Approval history
- approvedDec 24, 1998
Chemistry & pharmacology
Loading structure…
SMILES
NC(=O)C[S+]([O-])C(c1ccccc1)c1ccccc1- Mol. weight
- 273.36 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Racemic Mixture
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaModafinil ↗
- ChEMBLCHEMBL1373 ↗
- WikipediaVigil ↗
Also known as
- 2-((diphenylmethyl)sulfinyl)acetamide
- 2-((diphenylmethyl)sulfinyl)acetamide
- 2-((diphenylmethyl)sulfinyl)acetamide
- alertec
- benzhydrylsulfinylacetamide
- cep-1538
- cep-1538
- cepa brand of modafinil
- cephalon brand of modafinil
- cephalon brand of modafinil, reformulated
- crl 40476
- crl-40476
- crl-40476
- crl-40476
- draxis brand of modafinil
- lafon brand of modafinil
- merckle brand of modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- modafinil
- (+/-)-modafinil
- modafinilo
- modafinilo
- modafinilum
- modafinilum
- modanafil
- modaphonil
- moderateafinil
- moderateafinil
- modiodal
- modiodal
- modiodal
- nourypharma brand of modafinil
- provigil
- provigil
- provigil
- provigil
- sparlon
- thn102
- vigil
- vigil
- vigil
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07295834 | Phase 2 | Feb 1, 2026 | Imperial College London |
| NCT07231497 | Phase 3 | Dec 1, 2025 | National Institute of Mental Health (NIMH), University of Minnesota |
| NCT07263022 | Phase 3 | Dec 1, 2025 | National Institute of Mental Health (NIMH), University of Minnesota |
| NCT06354985 | Phase 3 | Oct 31, 2024 | University of Toronto |
| NCT06592352 | Phase 2 | Aug 27, 2024 | Clinical Academic Center, 2CA-Braga, Portugal |
| NCT06404099 | Phase 2 | Aug 12, 2024 | Duke University, Harvard University |
| NCT06404086 | Phase 2 | Jul 31, 2024 | Duke University, Harvard University |
| NCT06619665 | Phase 1 | Mar 19, 2024 | Merck |
| NCT07128719 | N/A | Jan 1, 2024 | Ain Shams University |
| NCT06041048 | Phase 4 | Oct 31, 2023 | University of California, Davis |
| NCT06665230 | Phase 1 | Sep 20, 2023 | Merck |
| NCT05675098 | Early Phase 1 (Phase 1) | May 1, 2023 | Kuwait University |
| NCT05351541 | Phase 1/Phase 2 (Phase 2) | Jan 31, 2023 | University of California, San Francisco |
| NCT05855187 | Phase 1 | Nov 15, 2022 | Genuine Research Center, Egypt |
| NCT05333250 | Phase 3 | May 31, 2022 | Bruyere Research Institute, University of Ottawa |
| NCT03893032 | Phase 2 | May 31, 2019 | United States Army |
| NCT03772314 | Phase 2 | Apr 15, 2019 | American Academy of Sleep Medicine, Emory University |
| NCT04317001 | Phase 3 | Dec 1, 2018 | Stanford University |
| NCT03621761 | Phase 4 | Oct 31, 2018 | National Multiple Sclerosis Society, Patient-Centered Outcomes Research Institute, University of Michigan, University of Washington |
| NCT03620253 | Phase 3 | Oct 31, 2018 | Government of Ontario, University of Toronto |
Showing 20 of 166 trials
Page 1 / 9
Organizations
Research & Development (134)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| National Institute on Drug Abuse (NIDA) | Government | 19 | 4 | 3 | 2001 |
| Cephalon | For profit | 18 | 9 | 4 | 2003 |
| Gradalis, Inc. | For profit | 14 | 13 | 4 | 2009 |
| University of California, San Francisco | Academic/Hospital | 7 | 6 | 4 | 2005 |
| Harvard University | Academic/Hospital | 6 | 2 | 4 | 2003 |
| National Institute of Mental Health (NIMH) | Government | 6 | 1 | 3 | 2003 |
| Department of Veteran Affairs | Government | 5 | 2 | 4 | 2003 |
| Hoosier Cancer Research Network | Academic/Hospital | 5 | 5 | 2 | 2006 |
| Mary Crowley Cancer Center | Academic/Hospital | 5 | 1 | 2 | 2009 |
| National Cancer Institute (NCI) | Government | 5 | 0 | 3 | 2002 |
| University of Texas at Houston | Academic/Hospital | 5 | 4 | 2 | 2004 |
| Columbia University | Academic/Hospital | 4 | 3 | 2 | 2004 |
| Medical University of South Carolina | Academic/Hospital | 4 | 0 | 3 | 2001 |
| Merck | For profit | 4 | 4 | 2 | 2008 |
| Bioprojet | For profit | 3 | 3 | 1 | 2009 |
| Duke University | Academic/Hospital | 3 | 3 | 2 | 2003 |
| Theranexus | For profit | 3 | 3 | 2 | 2015 |
| The University of Texas, Dallas | Academic/Hospital | 3 | 1 | 1 | 2006 |
| University of California, Davis | Academic/Hospital | 3 | 3 | 1 | 2005 |
| University of Minnesota | Academic/Hospital | 3 | 2 | 2 | 2010 |
134 organizations
Page 1 / 7
Marketing (23)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Nov 1, 2012 |
| Alembic | For profit | MKTG | Oct 18, 2012 |
| Alembic | For profit | SYN | Oct 18, 2012 |
| Apotex | For profit | MKTG | Feb 3, 2014 |
| Apotex | For profit | SYN | Feb 3, 2014 |
| Appco Pharma | For profit | MKTG | Aug 16, 2017 |
| Aurobindo Pharma | For profit | MKTG | Sep 27, 2012 |
| Barr Laboratories | For profit | MKTG | Jan 7, 2004 |
| Cadila Healthcare | For profit | MKTG | Sep 14, 2017 |
| Caraco Pharmaceutical Laboratories | For profit | MKTG | Jul 18, 2007 |
| Cephalon | For profit | NDA | Dec 24, 1998 |
| Heritage Pharma | For profit | MKTG | Aug 16, 2017 |
| Hikma | For profit | MKTG | Sep 26, 2012 |
| Mylan | For profit | MKTG | Jul 16, 2012 |
| Natco Pharma | For profit | MKTG | Jul 16, 2012 |
| Novartis | For profit | MKTG | Dec 29, 2006 |
| Orbion Pharms | For profit | MKTG | Sep 26, 2012 |
| Orchid Pharma | For profit | MKTG | Sep 26, 2012 |
| Sandoz | For profit | MKTG | Dec 29, 2006 |
| Sun Pharmaceuticals | For profit | MKTG | Jul 18, 2007 |
| Teva | For profit | MKTG | Dec 16, 2005 |
| Watson Pharmaceuticals | For profit | MKTG | Nov 1, 2012 |
| Zydus Discovery DMCC | For profit | MKTG | Sep 14, 2017 |