Modafinil

also known as Provigil · Alertec · Vigil · 2-\[(Diphenylmethyl) sulfinyl\]acetamide · CEP 1538 · Code name: Modafinil · CRC-40476 · CRL 40476 · +11 more

Small molecule targets SLC6A3 via inhibition

Developed for: cocaine dependence · schizophrenia · cognitive disorder · narcolepsy · methamphetamine dependence · substance-related disorder · attention deficit-hyperactivity disorder · hypersomnia
+43 more
· obstructive sleep apnea syndrome · schizoaffective disorder · major depressive disorder · multiple sclerosis · Parkinson disease · alcohol-related disorders · Alzheimer disease · bipolar disorder · cocaine abuse · depressive disorder · insomnia · narcolepsy-cataplexy syndrome · sleep disorder · alcohol dependence · atypical depressive disorder · autonomic nervous system disorder · brain injury · breast cancer · cannabis dependence · cardiac rhythm disease · cerebral palsy · circadian rhythm sleep disorder, shift work type · myalgic encephalomeyelitis/chronic fatigue syndrome · nicotine dependence · non-small cell lung carcinoma · orthostatic hypotension · postpoliomyelitis syndrome · postural orthostatic tachycardia syndrome · prostate cancer · relapsing-remitting multiple sclerosis · sleep apnea syndrome · sleep disorder, initiating and maintaining sleep · substance dependence · systemic lupus erythematosus · traumatic brain injury · brain neoplasm · delirium · idiopathic hypersomnia · inflammatory bowel disease · narcolepsy without cataplexy · perceptual disorders · post-traumatic stress disorder · tinnitus
Investigated by: Cephalon · National Institute on Drug Abuse (NIDA) · National Institute of Mental Health (NIMH) · Merck Sharp & Dohme LLC · National Cancer Institute (NCI) · The University of Texas Health Science Center, Houston
+99 more
· California Pacific Medical Center Research Institute · Medical University of South Carolina · New York State Psychiatric Institute · Yale University · Australian Government Department of Health and Ageing · Duke University · Icahn School of Medicine at Mount Sinai · Jazz Pharmaceuticals · Kessler Foundation · Kirketon Road Centre, Sydney Hospital · Kyle Kampman · Mylan Pharmaceuticals Inc · National Center for Advancing Translational Sciences (NCATS) · Pfizer · St Vincent's Hospital, Sydney · The University of New South Wales · U.S. Department of Education · University of California, Los Angeles · University of California, San Francisco · University of Minnesota · University of Rochester · University of South Florida · Abdulraheem Mohamed Gouda · American College of Gastroenterology · Assistance Publique - Hôpitaux de Paris · Bioprojet · Brigham and Women's Hospital · Brown University · Cambridge University Hospitals NHS Foundation Trust · Catherine Martin, MD · Charite University, Berlin, Germany · Clinical Academic Center (2CA-Braga) · Craig Hospital · Eli Lilly and Company · Emory University · Enhanced Emirates Limited · European Union · Gary Morrow · Hadassah Medical Organization · Hospital for Special Surgery, New York · Institute for Clinical Research · International Brain Research Foundation · Johns Hopkins University · Jonsson Comprehensive Cancer Center · Joshua Woolley, MD, PhD · K. Lieb · Kuwait University · Laval University · Manhattan Psychiatric Center · Mayo Clinic · Mission Interministérielle de Lutte contre la Drogue et la Toxicomanie · National Institute of Neurological Disorders and Stroke (NINDS) · National Multiple Sclerosis Society · National Taiwan University Hospital · Neuropsychiatric Research Institute, Fargo, North Dakota · North Suffolk Mental Health Association · Ontario Ministry of Health and Long Term Care · Orasi Medical, Inc. · Ottawa Hospital Research Institute · Patient-Centered Outcomes Research Institute · Pierre Fabre Laboratories · Qualissima · Sanofi · Satish R. Raj · Seoul National University Bundang Hospital · Sheba Medical Center · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Takeda · Technical University of Munich · Teva Branded Pharmaceutical Products R&D, Inc. · The Canadian Biomarker Integration Network in Depression · The Dana Foundation · The Mind Research Network · The Ottawa Hospital · all 105 on the full record

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	PROVIGIL	—	2004-01-23	fda.gov ↗
Approved	US (FDA)	PROVIGIL	—	1998-12-24	fda.gov ↗

Trials 120 · started per year

today

US approved 1998

19971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 05 trials
Phase 0	NCT05675098	May 2023 → Feb 2025 overdue	cerebral palsy, neurodevelopmental disorder	Kuwait University	Not yet recruiting	No outcome recorded
Phase 0	NCT01988883	Oct 2014 → Dec 2026 expected	postural orthostatic tachycardia syndrome	Vanderbilt University Medical Center	Active not recruiting	No outcome recorded
Phase 0	NCT01951508	Oct 2013 → Dec 2014	mood disorder, substance-related disorder	University Hospital, Basel, Switzerland	Completed	No outcome recorded
Phase 0	NCT01684306	Feb → Apr 2011	—	Università degli Studi 'G. d'Annunzio' Chieti e Pescara	Completed	No outcome recorded
Phase 0	NCT00842985	Sep 2008 → Oct 2009	cannabis dependence	Yale University	Completed	No outcome recorded
Phase 120 trials · 1 met primary · 1 missed
Phase 1	NCT07852130	Mar → Sep 2026	—	Abdulraheem Mohamed Gouda	Completed	No outcome recorded
Phase 1	NCT06619665	Mar → Jul 2024	narcolepsy	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT06665230	Sep → Nov 2023	narcolepsy	Merck Sharp & Dohme LLC	Completed	No outcome recorded
Phase 1	NCT03522506	May → Nov 2018	—	Takeda	Completed	Mixed
Phase 1	NCT03469089	Mar → May 2018	schizophrenia	University of Eastern Finland	Unknown	No outcome recorded
Phase 1	NCT03864042	Jan 2018 → Jul 2022	cancer, metastatic melanoma	Pfizer	Completed	No outcome recorded
Phase 1	NCT02222441	Oct → Dec 2014	—	Pfizer	Completed	No outcome recorded
Phase 1	NCT01903824	Aug → Oct 2013	cognitive disorder	Teva Branded Pharmaceutical Products R&D, Inc.	Completed	No outcome recorded
Phase 1	NCT01461174	Nov 2011 → Nov 2014	—	Qualissima	Completed	No outcome recorded
Phase 1	NCT01834547	May 2011 → Apr 2013	—	K. Lieb	Completed	No outcome recorded
Phase 1	NCT01092780	May 2010 → May 2011	sleep apnea syndrome	Merck Sharp & Dohme LLC	Completed	Met primary
Phase 1	NCT00943176	Jun 2009 → Apr 2011	primary biliary cholangitis	Mayo Clinic	Completed	Missed primary
Phase 1	NCT00265278	Mar 2005 → Mar 2006	substance-related disorder	National Institute on Drug Abuse (NIDA)	Unknown	No outcome recorded
Phase 1	NCT00258479	Jun 2003 → Dec 2011	nicotine dependence	Catherine Martin, MD	Completed	No outcome recorded
Phase 1	NCT00057707	Mar 2003 → Jun 2017	schizoaffective disorder, schizophrenia	National Institute of Mental Health (NIMH)	Completed	No outcome recorded
Phase 1	NCT00650000	Oct 2002	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00702637	Oct 2002 → Mar 2005	—	Craig Hospital	Completed	No outcome recorded
Phase 1	NCT00650286	Sep → Oct 2002	—	Mylan Pharmaceuticals Inc	Completed	No outcome recorded
Phase 1	NCT00223691	Mar 2002 → Jan 2017	autonomic nervous system disorder, orthostatic hypotension	Vanderbilt University	Completed	Mixed
Phase 1	NCT00033046	Jun 2001 → Apr 2002	substance-related disorder	National Institute on Drug Abuse (NIDA)	Unknown	No outcome recorded

Phase 1/25 trials · 1 missed
Phase 1/2	NCT05333250	Jan 2026 → Oct 2027 expected	cancer-related condition	Ottawa Hospital Research Institute	Recruiting	No outcome recorded
Phase 1/2	NCT05351541	Dec 2023 → Jul 2026 overdue	chronic pain syndrome	Joshua Woolley, MD, PhD	Active not recruiting	No outcome recorded
Phase 1/2	NCT02696512	Mar 2016 → Mar 2017	brain injury	International Brain Research Foundation	Unknown	No outcome recorded
Phase 1/2	NCT00314639	Sep 2005 → Jun 2008	schizophrenia	Laval University	Completed	No outcome recorded
Phase 1/2	NCT00262470	Apr 1997 → Dec 2029 expected	cardiac rhythm disease	Satish R. Raj	Active not recruiting	Missed primary
Phase 232 trials · 3 missed
Phase 2	NCT06592352	Aug 2024 → Jun 2026 overdue	cognitive disorder, multiple sclerosis	Clinical Academic Center (2CA-Braga)	Recruiting	No outcome recorded
Phase 2	NCT06404086	Jul 2024 → Dec 2025	hypersomnia, long COVID-19	Duke University	Completed	No outcome recorded
Phase 2	NCT03893032	Jul → Oct 2019	—	United States Army Aeromedical Research Laboratory	Unknown	No outcome recorded
Phase 2	NCT03624920	Jul 2018 → Dec 2019	Parkinson disease	Theranexus	Completed	No outcome recorded
Phase 2	NCT03424681	Dec 2017 → Aug 2018	alcohol-related disorders	The Mind Research Network	Completed	No outcome recorded
Phase 2	NCT02896712	Nov 2016 → Sep 2021	substance-related disorder	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 2	NCT02857244	Nov 2016 → Nov 2017	Parkinson disease	University of Chicago	Withdrawn	No outcome recorded
Phase 2	NCT01354470	Oct 2011 → Feb 2013	methamphetamine dependence	California Pacific Medical Center Research Institute	Completed	No outcome recorded
Phase 2	NCT01381718	Aug 2011 → Aug 2016	brain cancer, cognitive disorder, poisoning	University of South Florida	Completed	No outcome recorded
Phase 2	NCT01348607	Jul 2010 → Nov 2012	central nervous system cancer, sleep disorder	University of South Florida	Terminated	No outcome recorded
Phase 2	NCT01137396	Apr 2010 → Feb 2015	cocaine dependence	Yale University	Completed	No outcome recorded
Phase 2	NCT00630097	Dec 2009 → Jun 2011	methamphetamine dependence	California Pacific Medical Center Research Institute	Unknown	No outcome recorded
Phase 2	NCT01778010	Mar 2009 → Mar 2013	cocaine dependence	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 2	NCT00613015	May 2008 → Jul 2012	cocaine dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 2	NCT00670813	May 2008 → Nov 2009	depressive disorder	Technical University of Munich	Withdrawn	No outcome recorded
Phase 2	NCT00838227	Feb 2008 → Jan 2012	schizophrenia	Manhattan Psychiatric Center	Withdrawn	No outcome recorded Stop: Business
Phase 2	NCT00620659	Feb 2008 → Feb 2009	hypersomnia, obstructive sleep apnea syndrome	Merck Sharp & Dohme LLC	Terminated	Missed primary
Phase 2	NCT00538655	Jan 2008 → Jan 2009	methamphetamine dependence	California Pacific Medical Center Research Institute	Completed	No outcome recorded
Phase 2	NCT00569374	Sep 2007 → Sep 2008	methamphetamine dependence	University of Arkansas	Completed	No outcome recorded
Phase 2	NCT00368290	Sep 2006 → Jan 2013	cocaine dependence	Kyle Kampman	Completed	No outcome recorded
Phase 2	NCT00218036	Jul 2006 → Feb 2010	cocaine abuse, opiate dependence	The University of Texas Health Science Center, Houston	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00123370	Jul 2006 → Sep 2007	substance dependence	The University of New South Wales	Unknown	No outcome recorded
Phase 2	NCT00315276	May 2006 → Jan 2007	attention deficit-hyperactivity disorder	Cephalon	Completed	No outcome recorded
Phase 2	NCT00218062	Mar 2006 → Jan 2012	cocaine dependence	The University of Texas Health Science Center, Houston	Completed	Missed primary
Phase 2	NCT00218023	Mar 2006 → Apr 2012	cocaine abuse	The University of Texas Health Science Center, Houston	Completed	No outcome recorded
Phase 2	NCT00142818	Feb 2006 → Aug 2013	alcohol dependence, cocaine dependence	Kyle Kampman	Completed	Missed primary
Phase 2	NCT00123383	Jul 2005 → Sep 2007	cocaine dependence	The University of New South Wales	Unknown	No outcome recorded
Phase 2	NCT00233090	Jul 2005 → Dec 2008	—	Icahn School of Medicine at Mount Sinai	Terminated	No outcome recorded Stop: Enrollment
Phase 2	NCT00100100	Oct 2004 → Dec 2006	cocaine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00129285	Jul 2004 → Jan 2008	cocaine dependence	University of Pennsylvania	Completed	No outcome recorded
Phase 2	NCT00178373	May 2004 → Dec 2005	cancer	University of Rochester	Completed	No outcome recorded
Phase 2	NCT00218387	Apr 2004 → Jul 2010	cocaine dependence	Medical University of South Carolina	Completed	No outcome recorded

Phase 2/31 trial
Phase 2/3	NCT00215176	Feb 2003 → Apr 2005	atypical depressive disorder	Duke University	Completed	No outcome recorded
Phase 320 trials · 1 met primary · 3 missed
Phase 3	NCT07263022	Jul 2026 → Apr 2030 expected	bipolar disorder, major depressive disorder, schizoaffective disorder, schizophrenia +1	University of Minnesota	Not yet recruiting	No outcome recorded
Phase 3	NCT07231497	Oct 2025 → Apr 2030 expected	—	University of Minnesota	Recruiting	No outcome recorded
Phase 3	NCT03620253	Oct 2018 → Aug 2019	cognitive disorder, major depressive disorder	Unity Health Toronto	Terminated	No outcome recorded
Phase 3	NCT03185065	Oct 2017 → Nov 2019	myalgic encephalomeyelitis/chronic fatigue syndrome	Johns Hopkins University	Completed	Missed primary
Phase 3	NCT01067235	Oct 2009 → Jul 2010	narcolepsy-cataplexy syndrome	Bioprojet	Completed	No outcome recorded
Phase 3	NCT00917748	Jun 2009 → Mar 2011	breast cancer, prostate cancer	Sanofi	Completed	Missed primary
Phase 3	NCT00701532	Apr 2009 → Oct 2012	cocaine dependence	Assistance Publique - Hôpitaux de Paris	Completed	No outcome recorded
Phase 3	NCT00343811	Jun → Sep 2006	attention deficit-hyperactivity disorder	Cephalon	Completed	No outcome recorded
Phase 3	NCT00267332	Jan → Dec 2006	cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00228540	Sep 2005 → Sep 2006	attention deficit-hyperactivity disorder	Cephalon	Completed	No outcome recorded
Phase 3	NCT00236080	Aug → Dec 2005	circadian rhythm sleep disorder, shift work type	Cephalon	Completed	No outcome recorded
Phase 3	NCT01172145	Jul 2005 → Sep 2007	Alzheimer disease	Brown University	Completed	Missed primary
Phase 3	NCT00214968	Jan → Oct 2005	narcolepsy	Cephalon	Completed	No outcome recorded
Phase 3	NCT00107848	Oct 2004 → Sep 2005	narcolepsy, obstructive sleep apnea syndrome	Cephalon	Completed	No outcome recorded
Phase 3	NCT00107796	Oct 2004 → Sep 2005	narcolepsy	Cephalon	Completed	No outcome recorded
Phase 3	NCT00107809	Oct 2004 → Sep 2005	obstructive sleep apnea syndrome	Cephalon	Completed	No outcome recorded
Phase 3	NCT00214981	Sep 2003 → Sep 2006	attention deficit-hyperactivity disorder	Cephalon	Completed	No outcome recorded
Phase 3	NCT00067496	Aug 2003 → Aug 2006	postpoliomyelitis syndrome	National Institute of Neurological Disorders and Stroke (NINDS)	Terminated	No outcome recorded
Phase 3	NCT00066170	Apr 2003 → Jul 2004	narcolepsy	Jazz Pharmaceuticals	Completed	Met primary
Phase 3	NCT00042848	Aug 2002 → Apr 2007	cancer of unknown primary site	Gary Morrow	Completed	No outcome recorded

Phase 416 trials · 2 met primary · 1 missed
Phase 4	NCT01965925	Jan 2014 → Nov 2017	bipolar disorder	Icahn School of Medicine at Mount Sinai	Completed	No outcome recorded
Phase 4	NCT01913327	Apr 2013 → Jan 2017	schizoaffective disorder, schizophrenia, schizophreniform disorder	University of California, San Francisco	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT02385656	Mar 2013 → Feb 2016	—	Seoul National University Bundang Hospital	Unknown	No outcome recorded
Phase 4	NCT01365897	Sep 2010 → Jan 2011	—	Universidad de Valparaiso	Completed	No outcome recorded
Phase 4	NCT00829322	Feb 2009 → May 2012	non-small cell lung carcinoma	University of Oxford	Completed	Missed primary
Phase 4	NCT00751023	Feb 2009 → Jul 2010	methamphetamine dependence	Medical University of South Carolina	Completed	No outcome recorded
Phase 4	NCT00711464	May 2008 → Jul 2012	schizophrenia	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT00626210	Feb 2008 → Apr 2011	Alzheimer disease, insomnia, sleep disorder, initiating and maintaining sleep	VA Palo Alto Health Care System	Terminated	No outcome recorded
Phase 4	NCT00614926	Jun 2006 → Jul 2008	—	New York State Psychiatric Institute	Completed	No outcome recorded
Phase 4	NCT00423943	Sep 2005 → Dec 2012	schizoaffective disorder, schizophrenia	University of California, Los Angeles	Completed	No outcome recorded
Phase 4	NCT00124384	Jan 2005 → Aug 2007	insomnia	University of Rochester	Completed	No outcome recorded
Phase 4	NCT00118378	Dec 2004 → Jun 2010	HIV infectious disease	New York State Psychiatric Institute	Completed	Met primary
Phase 4	NCT00102284	Mar 2004 → Apr 2005	—	University Hospital Muenster	Terminated	No outcome recorded
Phase 4	NCT00086281	Nov 2003 → Jun 2005	obstructive sleep apnea syndrome	Jazz Pharmaceuticals	Completed	Met primary
Phase 4	NCT00573417	Sep 2003 → Nov 2007	schizophrenia	North Suffolk Mental Health Association	Completed	No outcome recorded
Phase 4	NCT00208715	Feb 2003 → Oct 2004	major depressive disorder	Emory University	Completed	No outcome recorded

Phase not applicable21 trials
—	NCT07568574	Mar 2026 → May 2028 expected	—	Enhanced Emirates Limited	Enrolling by invitation	No outcome recorded
—	NCT03426202	Jan 2018 → Jan 2020	—	University of Electronic Science and Technology of China	Unknown	No outcome recorded
—	NCT02071615	Aug 2013 → Mar 2014	—	Charite University, Berlin, Germany	Completed	No outcome recorded
—	NCT00916253	Mar 2010 → Jul 2012	hypersomnia, narcolepsy	University Hospital, Bordeaux	Completed	No outcome recorded
—	NCT02051153	Oct 2009 → Aug 2011	CGF1	Cambridge University Hospitals NHS Foundation Trust	Completed	No outcome recorded
—	NCT00972985	Sep → Dec 2009	—	Orasi Medical, Inc.	Completed	No outcome recorded
—	NCT00396734	Apr 2007 → Apr 2011	substance-related disorder	Hadassah Medical Organization	Suspended	No outcome recorded
—	NCT00582491	Aug 2006 → Feb 2009	cocaine dependence, cognitive disorder, sleep disorder	Yale University	Completed	No outcome recorded
—	NCT00636896	Jul 2006 → Aug 2007	—	Neuropsychiatric Research Institute, Fargo, North Dakota	Completed	No outcome recorded
—	NCT00305292	Mar → Aug 2006	alcohol-related disorders	University of California, San Francisco	Terminated	No outcome recorded
—	NCT00393562	Mar 2006 → Oct 2007	Parkinson disease	US Department of Veterans Affairs	Withdrawn	No outcome recorded Stop: Enrollment
—	NCT00297284	Feb 2006 → Feb 2007	systemic lupus erythematosus	Hospital for Special Surgery, New York	Terminated	No outcome recorded
—	NCT00220506	Sep 2005 → Dec 2006	multiple sclerosis	Sheba Medical Center	Unknown	No outcome recorded
—	NCT00895570	Jan 2005 → Apr 2007	glucose metabolism disease	Brigham and Women's Hospital	Completed	No outcome recorded
—	NCT00112515	Feb 2004 → ?	cancer of unknown primary site, cognitive disorder, depressive disorder	University of Virginia	Unknown	No outcome recorded
—	NCT00174174	Sep 2003 → ?	hypersomnia, narcolepsy-cataplexy syndrome	National Taiwan University Hospital	Completed	No outcome recorded
—	NCT00489892	Aug 2003 → Dec 2008	traumatic brain injury	Kessler Foundation	Unknown	No outcome recorded
—	NCT00142402	Jun 2003 → Sep 2006	multiple sclerosis	Kessler Foundation	Completed	No outcome recorded
—	NCT00546403	Feb 2003 → Feb 2008	schizophrenia	Veterans Medical Research Foundation	Completed	No outcome recorded
—	NCT00210301	Jan 2003 → ?	relapsing-remitting multiple sclerosis	Institute for Clinical Research	Unknown	No outcome recorded
—	NCT00052286	Sep 2002 → Jul 2006	brain cancer, cognitive disorder	Jonsson Comprehensive Cancer Center	Completed	No outcome recorded

Comparator or background therapy36 trials
Phase 1	NCT02603861 Comparator	Nov 2015 → Mar 2016	—	Eli Lilly and Company	Completed	No outcome recorded
Phase 1	NCT03182413 Comparator	Sep → Dec 2015	—	Theranexus	Completed	Met primary
Phase 1	NCT02538744 Comparator	Aug 2015 → Aug 2018	cocaine dependence	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT01601730 Comparator	Aug 2010 → Jul 2011	cocaine abuse, cocaine dependence	Baylor College of Medicine	Completed	No outcome recorded
Phase 1	NCT00591019 Comparator	Aug 2006 → Mar 2008	tinnitus	University of Arkansas	Terminated	No outcome recorded
Phase 1/2	NCT00838981 Comparator	May 2008 → Mar 2014	cocaine dependence	Yale University	Completed	No outcome recorded
Phase 2	NCT07295834 Comparator	Feb 2026 → Dec 2027 expected	Crohn disease, ulcerative colitis	Imperial College London	Not yet recruiting	No outcome recorded
Phase 2	NCT06404099 Comparator	Aug 2024 → Mar 2026	hypersomnia, long COVID-19	Duke University	Completed	No outcome recorded
Phase 2	NCT03772314 Comparator	Apr 2019 → May 2023	idiopathic hypersomnia, narcolepsy without cataplexy	Emory University	Completed	No outcome recorded
Phase 2	NCT03083132 Comparator	Jun 2017 → Nov 2019	Parkinson disease	University of Arkansas	Completed	No outcome recorded
Phase 2	NCT02821715 Comparator	Sep 2016 → Dec 2018	narcolepsy	Theranexus	Completed	Missed primary
Phase 2	NCT02376257 Comparator	Sep 2014 → Apr 2017	major depressive disorder	Boston University Charles River Campus	Completed	No outcome recorded
Phase 2	NCT01085903 Comparator	Mar 2010 → Aug 2015	perceptual disorders	University of Arkansas	Completed	No outcome recorded
Phase 2	NCT00859573 Comparator	Apr 2009 → Jan 2010	methamphetamine dependence	University of Arkansas	Terminated	No outcome recorded Stop: Business
Phase 2	NCT03914118 Comparator	Jan 2008 → Jan 2013	—	The Cooper Health System	Completed	No outcome recorded
Phase 2	NCT00520286 Comparator	Dec 2007 → Dec 2009	methamphetamine dependence	National Institute on Drug Abuse (NIDA)	Completed	No outcome recorded
Phase 2	NCT00469508 Comparator	Apr 2007 → Jan 2009	methamphetamine dependence	University of California, Los Angeles	Completed	No outcome recorded
Phase 2	NCT00424931 Comparator	Jan → Nov 2007	narcolepsy	Alza Corporation	Completed	No outcome recorded
Phase 2	NCT00344565 Comparator	Nov 2005 → Dec 2006	cocaine dependence	Research Foundation for Mental Hygiene, Inc.	Completed	No outcome recorded
Phase 2/3	NCT07582458 Comparator	Aug 2026 → Feb 2027 expected	inflammatory bowel disease, myalgic encephalomeyelitis/chronic fatigue syndrome	Radboud University Medical Center	Recruiting	No outcome recorded
Phase 2/3	NCT01726088 Comparator	Aug 2012 → May 2013	post-traumatic stress disorder	Biomedical Research Foundation	Unknown	No outcome recorded
Phase 3	NCT06354985 Comparator	Sep 2025 → Sep 2027 expected	stroke disorder	University Health Network, Toronto	Not yet recruiting	No outcome recorded
Phase 3	NCT04317001 Comparator	Dec 2018 → Nov 2022	major depressive disorder	Stanford University	Withdrawn	No outcome recorded
Phase 3	NCT02028260 Comparator	Jan 2014 → Jul 2015	delirium, respiratory failure	Brigham and Women's Hospital	Withdrawn	No outcome recorded Stop: Enrollment
Phase 3	NCT01800097 Comparator	Oct 2012 → Mar 2015	stroke disorder	Herlev Hospital	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT01766323 Comparator	Sep 2012 → Jun 2013	cancer, hypersomnia	Dr. Rajendra Prasad Government Medical College	Unknown	No outcome recorded
Phase 3	NCT01440621 Comparator	Aug 2010 → Feb 2012	—	Indira Gandhi Medical College, Shimla	Completed	No outcome recorded
Phase 3	NCT01067222 Comparator	May 2009 → Jul 2010	hypersomnia, narcolepsy-cataplexy syndrome	Bioprojet	Completed	Mixed
Phase 3	NCT00418691 Comparator	Feb 2004 → Nov 2009	brain neoplasm	M.D. Anderson Cancer Center	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT07830056 Comparator	Feb 2025 → Oct 2026 expected	—	United States Army Research Institute of Environmental Medicine	Recruiting	No outcome recorded
Phase 4	NCT06041048 Comparator	Oct 2023 → Dec 2026 expected	—	University of California, Davis	Recruiting	No outcome recorded
Phase 4	NCT03621761 Comparator	Nov 2018 → Aug 2021	multiple sclerosis	University of Michigan	Completed	No outcome recorded
Phase 4	NCT03616717 Comparator	Oct 2018 → May 2021	—	University of California, San Diego	Completed	No outcome recorded
Phase 4	NCT02494102 Comparator	Feb 2016 → Apr 2018	obstructive sleep apnea syndrome	Milton S. Hershey Medical Center	Terminated	No outcome recorded
Phase 4	NCT02155257 Comparator	Jul 2014 → Oct 2017	osteoarthritis	Wake Forest University Health Sciences	Completed	No outcome recorded
—	NCT07128719 Comparator	Jan 2024 → Jan 2025	—	Ain Shams University	Completed	No outcome recorded

News releases announcing trial results or a regulatory action · 11

Date	Issuer	Release
2026-09-04	Lupin Limited	Regulatory Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP lupin.com ↗ The U.S. FDA has approved Lupin’s Modafinil Tablets USP, 100 mg and 200 mg as bioequivalent to the reference listed drug (RLD), Provigil® Tablets of Nuvo Pharmaceuticals (Ireland) DAC, and is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA) or shift work disorder (SWD).
2020-07-30	Theranexus	Results THERANEXUS TO PRESENT THE RESULTS OF THN102 FOR PARKINSON'S DISEASE AT THE 2020 INTERNATIONAL CONGRESS OF PARKINSON'S DISEASE AND MOVEMENT DISORDERS actusnews.com ↗ The ESS score improved by 3.9 points in patients after treatment with THN102-200/2.
2020-03-31	Theranexus	Results THERANEXUS ANNOUNCES THE SUCCESS OF ITS PHASE II TRIAL FOR THN102 IN PARKINSON'S PATIENTS actusnews.com ↗
2019-09-03	Theranexus	Results THERANEXUS ANNOUNCES THE PUBLICATION OF TWO SCIENTIFIC PAPERS AND A PRESENTATION AT THE EUROPEAN PAIN CONGRESS (EFIC) TO BE HELD ON 3-7 SEPTEMBER IN VALENCIA, SPAIN actusnews.com ↗
2019-02-27	Theranexus	Results THERANEXUS ANNOUNCES PRELIMINARY RESULTS OF PHASE II TRIAL OF THN102 ON NARCOLEPSY PATIENTS actusnews.com ↗ However, the results do not indicate any difference in efficacy between THN102 (combination of modafinil and flecainide) and modafinil alone with respect to the trial’s primary endpoint (Epworth Sleepiness Scale).
2018-07-05	Theranexus	Results THERANEXUS PRESENTS NEW DATA ON THE STIMULATING EFFECT OF ITS DRUG CANDIDATE THN102 actusnews.com ↗ The research demonstrates that the histaminergic system is involved in the stimulating effect of THN102.
2018-06-26	Theranexus	Regulatory THERANEXUS ANNOUNCES GERMAN AUTHORITIES APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL IN PARKINSON'S DISEASE actusnews.com ↗ We are pleased to announce this approval in Germany which will allow the opening of several centres for the phase 2 Parkinson's study.
2018-05-22	Theranexus	Results THERANEXUS ANNOUNCES THE PUBLICATION OF A SCIENTIFIC ARTICLE ON THE MECHANISM OF ACTION OF DRUG CANDIDATE THN102 IN THE INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY actusnews.com ↗ The study has established the effect of drug candidate THN102, a combination of modafinil and flecainide, on brain metabolic activity by means of an approved imaging technique called positron emission tomography, with radiolabelled glucose (fludeoxyglucose or FDG).
2018-04-23	Theranexus	Regulatory THN102 OBTAINS INVESTIGATIONAL NEW DRUG STATUS FROM THE FOOD AND DRUG ADMINISTRATION (FDA) actusnews.com ↗ It therefore authorises the phase 2 clinical trial to assess the clinical benefit of the THN102, a combination of modafinil and flecainide in 60 patients with Parkinson’s disease and suffering from EDS.
2018-04-19	Theranexus	Regulatory THERANEXUS ANNOUNCES THE FIRST EUROPEAN APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL WITH THN 102 IN PARKINSON'S DISEASE PATIENTS actusnews.com ↗
2012-04-05	Teva Branded Pharmaceutical Products R&D, Inc.	Regulatory FDA Decides Teva is Sole First-to-File on Provigil® tevapharm.com ↗

All press releases naming this drug 17 releases

Date	Issuer	Release
2026-09-04	Lupin Limited	Lupin Receives U.S. FDA Approval for Modafinil Tablets, USP lupin.com ↗
2025-08-06	Sanofi	Press Release: Sanofi completes the acquisition of Vigil Neuroscience, Inc. sanofi.com ↗
2025-05-21	Sanofi	Press Release: Sanofi to acquire Vigil Neuroscience, Inc., adding a new investigational medicine to treat Alzheimer’s disease to the neurology pipeline sanofi.com ↗
2025-02-05	Apotex Inc.	Apotex acquires US rights to PROVIGIL® (modafinil) and NUVIGIL® (armodafinil) apotex.com ↗
2020-07-30	Theranexus	THERANEXUS TO PRESENT THE RESULTS OF THN102 FOR PARKINSON'S DISEASE AT THE 2020 INTERNATIONAL CONGRESS OF PARKINSON'S DISEASE AND MOVEMENT DISORDERS actusnews.com ↗
2020-03-31	Theranexus	THERANEXUS ANNOUNCES THE SUCCESS OF ITS PHASE II TRIAL FOR THN102 IN PARKINSON'S PATIENTS actusnews.com ↗
2019-09-03	Theranexus	THERANEXUS ANNOUNCES THE PUBLICATION OF TWO SCIENTIFIC PAPERS AND A PRESENTATION AT THE EUROPEAN PAIN CONGRESS (EFIC) TO BE HELD ON 3-7 SEPTEMBER IN VALENCIA, SPAIN actusnews.com ↗
2019-02-27	Theranexus	THERANEXUS ANNOUNCES PRELIMINARY RESULTS OF PHASE II TRIAL OF THN102 ON NARCOLEPSY PATIENTS actusnews.com ↗
2018-07-05	Theranexus	THERANEXUS PRESENTS NEW DATA ON THE STIMULATING EFFECT OF ITS DRUG CANDIDATE THN102 actusnews.com ↗
2018-06-26	Theranexus	THERANEXUS ANNOUNCES GERMAN AUTHORITIES APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL IN PARKINSON'S DISEASE actusnews.com ↗
2018-05-22	Theranexus	THERANEXUS ANNOUNCES THE PUBLICATION OF A SCIENTIFIC ARTICLE ON THE MECHANISM OF ACTION OF DRUG CANDIDATE THN102 IN THE INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY actusnews.com ↗
2018-04-23	Theranexus	THN102 OBTAINS INVESTIGATIONAL NEW DRUG STATUS FROM THE FOOD AND DRUG ADMINISTRATION (FDA) actusnews.com ↗
2018-04-19	Theranexus	THERANEXUS ANNOUNCES THE FIRST EUROPEAN APPROVAL FOR ITS PHASE 2 CLINICAL TRIAL WITH THN 102 IN PARKINSON'S DISEASE PATIENTS actusnews.com ↗
2012-04-05	Teva Branded Pharmaceutical Products R&D, Inc.	FDA Decides Teva is Sole First-to-File on Provigil® tevapharm.com ↗
2012-03-30	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Launch of Authorized Generic of Provigil® tevapharm.com ↗
2011-11-25	Tanabe Pharma Corporation	Approval of Additional Indication for MODIODAL® Tablets 100 mg a Sleep Disorder Treatment tanabe-pharma.com ↗
2005-12-09	Teva Branded Pharmaceutical Products R&D, Inc.	Teva Announces Agreement with Cephalon Regarding Settlement of Provigil® Patent Litigation tevapharm.com ↗

Evidence & citations 25 cited values

Every value below carries the sentence it was read from. 159 sources stand behind the page.

Field	Value	Cited text
Known as	modafinil	“Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ 153 “THN102 Dosage B : 200 mg/2 mg THN102 is a combination of modafinil 100mg and flecainide 1 mg daily dosage is 200 mg of modafinil and 2 mg of flecainide” NCT03624920 ↗ “Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo” NCT00842985 ↗ “Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective” NCT00208715 ↗ “Provigil (modafinil)” NCT00210301 ↗ NCT00214981 ↗ NCT03424681 ↗ NCT01800097 ↗ NCT01903824 ↗ NCT00469508 ↗ NCT00838981 ↗ Show 143 more sources
Known as	2-\[(Diphenylmethyl) sulfinyl\]acetamide	“Modafinil (2-\[(Diphenylmethyl) sulfinyl\]acetamide (Provigil, 1997)) is a novel drug which has a demonstrable efficacy in the treatment of daytime sleepiness associated with...” NCT02051153 ↗
Known as	Alertec	“The UCSF Pain Clinical Research Center (PCRC) is conducting a study of the effects of modafinil (Provigil®; Vigiver, Alertec), alcohol and the combination on alertness, mood,...” NCT00305292 ↗ 1 “Modafinil (Alertec) is officially indicated for improving wakefulness in patients with excessive daytime sleepiness associated with narcolepsy.” NCT00314639 ↗
Known as	CEP 1538	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	Code name: Modafinil	“Code name: Modafinil” NCT01684306 ↗
Known as	CRC-40476	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	CRL 40476	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	d, l-2-[(diphenylmethyl)sulfinyl]acetamide	“Modafinil (d, l-2-\[(diphenylmethyl)sulfinyl\]acetamide) is a novel wake- and vigilance-promoting agent” NCT00630097 ↗
Known as	DEP-1538	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	Modafinal	“To determine whether therapy with Modafinal(Provigil) is safe and effective in fatigue in MS Patients” NCT00220506 ↗
Known as	Modafinil civ	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	MODAFINIL COMPONENT OF THN-102	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	Modafinilo	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	Modaphonil	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	Modiodal	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	NSC-751178	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	NSC-759110	ChEMBL registry synonym — accepted as the source's own label CHEMBL1373 ↗
Known as	Provigil	“This 8-week, randomized, placebo-controlled pilot study evaluated the feasibility, safety and preliminary efficacy of the wake-promoting drug, modafinil (Provigil®), on...” PMID 37732080 ↗ Sep 2023 15 “The UCSF Pain Clinical Research Center (PCRC) is conducting a study of the effects of modafinil (Provigil®; Vigiver, Alertec), alcohol and the combination on alertness, mood,...” NCT00305292 ↗ “Modafinil (2-\[(Diphenylmethyl) sulfinyl\]acetamide (Provigil, 1997)) is a novel drug which has a demonstrable efficacy in the treatment of daytime sleepiness associated with...” NCT02051153 ↗ “An Examination of the Effects of Modafinil (Provigil) or Placebo on Neurocognitive Testing After General Anesthesia for Non-Cardiac Surgery in an Older Population” NCT03914118 ↗ “PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome” NCT00107848 ↗ “Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome” NCT00107809 ↗ “Patients who reported fatigue (N=867) were randomly assigned to receive either 200 mg of oral modafinil (Provigil) daily or a placebo.” PMID 20564068 ↗ Jul 2010 “Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy” NCT00107796 ↗ “administering modafinil (PROVIGIL®) to patients experiencing fatigue following completion of cancer treatment” NCT00178373 ↗ “Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective” NCT00208715 ↗ “Palbociclib (PD-0332991); Modafinil (Provigil)” NCT02222441 ↗ Show 5 more sources
Known as	Vigil	“Modafinil ( Vigil ®) is a drug used in the treatment of narcolepsy (sleeping sickness).” NCT02071615 ↗ 1 “Modafinil (Vigil)” NCT00670813 ↗
Known as	Vigiver	“The UCSF Pain Clinical Research Center (PCRC) is conducting a study of the effects of modafinil (Provigil®; Vigiver, Alertec), alcohol and the combination on alertness, mood,...” NCT00305292 ↗
Action	Activate	“modafinil (a proposed H1 agonist)” NCT00636896 ↗
Action	Inhibit	“Dopamine transporter inhibitor” CHEMBL1373 ↗
Modality	Small molecule	— CHEMBL1373 ↗
Route	Oral	“Patients who reported fatigue (N=867) were randomly assigned to receive either 200 mg of oral modafinil (Provigil) daily or a placebo.” PMID 20564068 ↗ Jul 2010
Target	SLC6A3	“Dopamine transporter inhibitor” CHEMBL1373 ↗