Provigil

(Modafinil)

ApprovedSmall molecule

Modafinil is used to treat excessive daytime sleepiness caused by conditions like narcolepsy, sleep apnea, or shift work sleep disorder. It helps people stay awake and alert during the day.[2] Provigil is currently approved and in use across 33 indications[4].[1]

Provigil is one of 660 small molecule programs targeting Parkinson disease. It is currently in Approved.

Indications

133

Total Trials

Active Trials

659

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Parkinson DiseaseApproved

Drug DependenceApproved

MelanomaApproved

Major Depressive DisorderApproved

Low Back PainApproved

StrokeApproved

Relapsing-Remitting Multiple SclerosisActive, not recruiting

Systemic Lupus ErythematosusActive, not recruiting

Addictive Alcohol UseActive, not recruiting

Narcolepsy-Cataplexy SyndromeActive, not recruiting

Parkinson DiseaseApproved

Approved

Drug DependenceApproved

Approved

MelanomaApproved

Approved

Major Depressive DisorderApproved

Approved

Low Back PainApproved

Approved

StrokeApproved

Approved

Relapsing-Remitting Multiple SclerosisPreclinical

Active, not recruiting

Systemic Lupus ErythematosusPreclinical

Active, not recruiting

Addictive Alcohol UsePreclinical

Active, not recruiting

Narcolepsy-Cataplexy SyndromeApproved

Active, not recruiting

Showing 10 of 32 indications

Competition

Competitive Landscape

206 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

25 2

Tagrisso

AstraZeneca

Phase 3

19 3

Beyfortus

BeiGene

Phase 3

10 4

Provigil

NNuvo Research GmbH

Approved

1 5

Abraxane

Bristol-Myers Squibb

Phase 3

7 6

Tecentriq

Roche

Phase 3

6 7

Alunbrig

Takeda

Phase 3

4 8

Alecensa

Roche

Phase 3

3 9

Verzenio

Eli Lilly

Phase 3

2 10

Zepzelca

Jazz Pharmaceuticals

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 1Active, not recruiting

Cognitive Function

NCT01988883

Q1 2027

Phase 1Not yet recruiting

Cerebral Palsy

NCT05675098

Q2 2027

PreclinicalRecruiting

Inflammatory Bowel Disease (crohn's Disease and Ulcerative Colitis)

NCT07582458

Q3 2027

Phase 3Not yet recruiting

Fatigue

NCT06354985

Clinical

Trials by Indication[1]

Fatigue11 trials

Modafinil in Treating Fatigue in Patients With Cancer

Unknown status·UUniversity of Virginia·N/A·NCT00112515

Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer

Completed·GGary Morrow·Phase 3·NCT00042848·837 enrolled

Effectiveness of Modafinil for Treating Fatigue in Adults With HIV/AIDS

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00118378·115 enrolled

Show 8 more trials

Treatment of Post Stroke Fatigue With a Wakefulness Promoting Agent

Terminated·HHerlev Hospital·Phase 3·NCT01800097·41 enrolled

Modafinil For Fatigue in IBD: A Feasibility Randomised Controlled Trial

Not yet recruiting·IImperial College London·Phase 2·NCT07295834·70 enrolled

Modafinil in Cancer Related Fatigue

Completed·IIndira Gandhi Medical College, Shimla·Phase 3·NCT01440621·217 enrolled

Modafinil to Treat Fatigue in Post-Polio Syndrome

Terminated·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00067496·30 enrolled

Modafinil for Treatment of Fatigue in ALS Patients

Completed·NNew York State Psychiatric Institute·Phase 4·NCT00614926·32 enrolled

Modafinil and Exercise for Post Stroke Fatigue

Not yet recruiting·UUniversity Health Network, Toronto·Phase 3·NCT06354985·212 enrolled

Modafinil to Reduce Persistent Fatigue in Patients Following Treatment for Cancer

Completed·UUniversity of Rochester·Phase 2·NCT00178373·96 enrolled

The Efficacy and Tolerability of Modafinil for Fatigue and Daytime Sleepiness in Cancer Patients: Preliminary Study

Unknown status·SSeoul National University Bundang Hospital·Phase 4·NCT02385656·20 enrolled

Cocaine Dependence9 trials

Modafinil, Sleep, and Cognition in Cocaine Dependence

Completed·YYale University·N/A·NCT00582491·44 enrolled

Modafinil for the Treatment of Cocaine Dependence - 1

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00100100·210 enrolled

Modafinil Treatment for Cocaine Dependence and HIV High-Risk Behavior

Completed·KKyle Kampman·Phase 2·NCT00368290·94 enrolled

Show 6 more trials

Modafinil - Escitalopram Study for Cocaine Dependence

Completed·—·Phase 1·NCT01601730·68 enrolled

Complementary Combination Therapy for Cocaine Dependence

Completed·—·Phase 1·NCT02538744·45 enrolled

Medications for Stopping Cocaine Dependence and Preventing Relapse

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00218023·101 enrolled

A Placebo-Controlled Double-Blind Combined Treatment of Modafinil and CBT for Cocaine Dependence

Completed·RResearch Foundation for Mental Hygiene, Inc.·Phase 2·NCT00344565·15 enrolled

Pharmacotherapy & CM for Opioid and Cocaine Dependence

Completed·YYale University·Phase 1/2·NCT00838981·91 enrolled

Randomised Placebo-Controlled Trial of Modafinil for Cocaine Dependence

Unknown status·TThe University of New South Wales·Phase 2·NCT00123383·10 enrolled

Methamphetamine Dependence9 trials

A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence

Completed·—·Phase 2·NCT01354470·72 enrolled

Phase 2, Multi-Center Trial of Modafinil for Methamphetamine Dependence

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 2·NCT00520286·210 enrolled

Safety and Tolerability of Modafinil for Methamphetamine Dependence

Completed·UUniversity of Arkansas·Phase 2·NCT00569374·8 enrolled

Show 6 more trials

A Dose Ranging Study of Modafinil for Methamphetamine Dependence

Unknown status·—·Phase 2·NCT00630097·90 enrolled

A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence

Completed·—·Phase 2·NCT00538655·20 enrolled

Modafinil for Methamphetamine Dependence

Terminated·UUniversity of Arkansas·Phase 2·NCT00859573·9 enrolled

Trial of Modafinil for Methamphetamine Dependence

Unknown status·TThe University of New South Wales·Phase 2·NCT00123370·87 enrolled

Modafinil vs Placebo for the Treatment of Methamphetamine Dependence

Completed·UUniversity of California, Los Angeles·Phase 2·NCT00469508·71 enrolled

Effects of Modafinil in Methamphetamine Dependence

Completed·MMedical University of South Carolina·Phase 4·NCT00751023·40 enrolled

Schizophrenia7 trials

Antipsychotic Effects on Brain Function in Schizophrenia

Terminated·UUniversity of California, San Francisco·Phase 4·NCT01913327·4 enrolled

A Placebo-Controlled Trial of Modafinil (Provigil) Added to Clozapine in Patients With Schizophrenia

Completed·NNorth Suffolk Mental Health Association·Phase 4·NCT00573417·40 enrolled

Modafinil as an Adjunctive on Cognitive Functioning in Patients With Schizophrenia

Completed·LLaval University·Phase 1/2·NCT00314639·30 enrolled

Show 4 more trials

Modafinil Effects on Cognition in Schizophrenia Patients

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00711464·29 enrolled

Modafinil Augmentation Therapy for Excessive Daytime Sleepiness and Negative Symptoms in Patients With Schizophrenia

Completed·VVeterans Medical Research Foundation·N/A·NCT00546403·26 enrolled

Effects of Modafinil on Brain Function in Patients With Schizophrenia

Completed·NNational Institute of Mental Health (NIMH)·Phase 1·NCT00057707·176 enrolled

Modafinil for Treatment of Cognitive Dysfunction in Schizophrenia

Completed·UUniversity of California, Los Angeles·Phase 4·NCT00423943·33 enrolled

Obstructive Sleep Apnea4 trials

Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

Completed·CCephalon·Phase 3·NCT00107809·140 enrolled

Trial of Effects of Oral Xyrem and Zolpidem on Sleep-Disordered Breathing in Obstructive Sleep Apnea Patients

Completed· Jazz Pharmaceuticals logo

Jazz Pharmaceuticals·Phase 4·NCT00086281·60 enrolled

Evaluation of Modafinil vs Placebo for Treatment of Anesthesia Delayed Emergence in Obstructive Sleep Apnea

Terminated·MMilton S. Hershey Medical Center·Phase 4·NCT02494102·105 enrolled

Show 1 more trial

PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

Completed·CCephalon·Phase 3·NCT00107848·280 enrolled

73 more indications

Narcolepsy3 trials

Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Completed·CCephalon·Phase 3·NCT00107796·140 enrolled

A Safety and Effectiveness Study of a Single Dose of JNJ-17216498 in Patients With Narcolepsy

Completed·AAlza Corporation, DE, USA·Phase 2·NCT00424931·16 enrolled

Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy

Completed·BBioprojet·Phase 3·NCT01067222·110 enrolled

Multiple Sclerosis3 trials

Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis

Completed·JJohns Hopkins University·Phase 3·NCT03185065·141 enrolled

Modafinil in Multiple Sclerosis

Completed·KKessler Foundation·N/A·NCT00142402·20 enrolled

Cognitive Behavioral Therapy, Modafinil, or Both for Multiple Sclerosis Fatigue

Completed·UUniversity of Michigan·Phase 4·NCT03621761·343 enrolled

Sleep3 trials

A Study of LY3154207 on Sleep in Healthy Male Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT02603861·16 enrolled

RECOVER-SLEEP: Platform Protocol

Completed·—·Phase 2·NCT06404086·830 enrolled

A Study of MK-6552 in Sleep Deprived Healthy Participants (MK-6552-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06619665·18 enrolled

Brain Injury2 trials

Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury

Completed·—·Phase 1·NCT00702637·60 enrolled

Post-Traumatic Brain Injury (Post-TBI) Fatigue and Its Treatment

Terminated·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT00233090·21 enrolled

Attention2 trials

Investigation of Locus Coeruleus Function in Sustained Attention

Recruiting·UUniversity of California, Davis·Phase 4·NCT06041048·40 enrolled

Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation

Completed·TTheranexus·Phase 1·NCT03182413·20 enrolled

Memory2 trials

Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil

Terminated·HHospital for Special Surgery, New York·N/A·NCT00297284·20 enrolled

Modafinil in Treating Children With Memory and Attention Problems Caused by Cancer Treatment for a Brain Tumor

Completed·UUniversity of South Florida·Phase 2·NCT01381718·112 enrolled

Depression2 trials

Improving Therapeutic Learning in Depression: Proof of Concept

Completed·—·Phase 2·NCT02376257·36 enrolled

Modafinil for Atypical Depression

Completed·—·Phase 2/3·NCT00215176·65 enrolled

Effectiveness2 trials

Effectiveness of Modafinil and D-amphetamine in Treating Cocaine Dependent Individuals

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00218062·73 enrolled

Effectiveness of Modafinil in Improving Cognitive Performance of University Students

Completed·UUniversidad de Valparaiso·Phase 4·NCT01365897·128 enrolled

AIN2 trials

Modafinil for Smoked Cocaine Self-Administration

Completed·NNew York State Psychiatric Institute·Phase 2·NCT01778010·8 enrolled

Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals - 8

Terminated·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00218036·54 enrolled

Psychosis2 trials

Cognitive Strategies in Early Psychosis 1

Recruiting·UUniversity of Minnesota·Phase 3·NCT07231497·103 enrolled

Cognitive Strategies in Early Psychosis 2

Recruiting·UUniversity of Minnesota·Phase 3·NCT07263022·24 enrolled

Cognitive Function2 trials

Modafinil and Cognitive Function in POTS

Active, not recruiting·VVanderbilt University Medical Center·Phase 1·NCT01988883·20 enrolled

Effects of Methylphenidate Versus Sustained Release Methylphenidate on Cognitive Functioning

Terminated·MM.D. Anderson Cancer Center·Phase 3·NCT00418691·34 enrolled

Excessive Daytime Sleepiness2 trials

Comparison of Modafinil and Methylphenidate in Treatment of Excessive Daytime Sleepiness in Patients With Parkinson's Disease

Withdrawn·UUS Department of Veterans Affairs·N/A·NCT00393562

Methylphenidate HCl or Modafinil in Treating Young Patients With Excessive Daytime Sleepiness After Cancer Therapy

Terminated·UUniversity of South Florida·Phase 2·NCT01348607·1 enrolled

Adolescent1 trial

Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents

Completed·—·Phase 1·NCT00258479·24 enrolled

Brain Cancer1 trial

Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer

Completed·JJonsson Comprehensive Cancer Center·N/A·NCT00052286·29 enrolled

Orthostatic Intolerance1 trial

Treatment of Orthostatic Intolerance

Active, not recruiting·SSatish R. Raj·Phase 1/2·NCT00262470·150 enrolled

Bipolar Disorder1 trial

Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil

Completed·IIcahn School of Medicine at Mount Sinai·Phase 4·NCT01965925·18 enrolled

Sts1 trial

Touchscreen-based Cognitive Tests in Healthy Volunteers

Unknown status·UUniversity of Eastern Finland·Phase 1·NCT03469089·16 enrolled

Electroencephalography1 trial

Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test

Completed·OOrasi Medical, Inc.·N/A·NCT00972985·15 enrolled

Safety and Efficacy1 trial

Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD

Completed·CCephalon·Phase 3·NCT00214981

Attention Deficit Hyperactivity Disorder1 trial

Study to Evaluate the Efficacy of Modafinil Treatment in Patients With Attention Deficit Hyperactivity Disorder (ADHD) Who Are Responders to Modafinil Treatment

Completed·CCephalon·Phase 3·NCT00343811·120 enrolled

Satisfaction1 trial

Study to Assess Satisfaction With Modafinil Treatment in Children and Adolescents With ADHD

Completed·CCephalon·Phase 3·NCT00228540

Alcohol Dependence1 trial

Modafinil and Naltrexone to Reduce Cocaine and Alcohol Dependence

Completed·KKyle Kampman·Phase 2·NCT00142818·164 enrolled

Advanced Solid Tumors1 trial

Pharmacokinetic Drug-drug Interaction Study of Encorafenib and Binimetinib on Probe Drugs in Patients With BRAF V600-mutant Melanoma or Other Advanced Solid Tumors

Completed· Pfizer logo

Pfizer·Phase 1·NCT03864042·56 enrolled

Morphine1 trial

Palliative Morphine With or Without Concurrent Modafinil

Unknown status·—·Phase 3·NCT01766323·200 enrolled

Bariatric Surgery1 trial

Study Effects of Preoperative Modafinil on Recovery Profile of Morbidly Obese Patients Scheduled for Bariatric Surgery if it Can Enhance Recovery From Anesthesia

Completed·—·N/A·NCT07128719·20 enrolled

Driving1 trial

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies

Completed·UUniversity Hospital, Bordeaux·N/A·NCT00916253·27 enrolled

Cognitive Functions1 trial

Effects of Donepezil and Memantine on Cognitive Functions After a Sleep Deprivation Challenge in Healthy Volunteers

Completed·QQualissima·Phase 1·NCT01461174·36 enrolled

Apathy1 trial

Treatment of Apathy in Alzheimer's Disease With Modafinil

Completed·—·Phase 3·NCT01172145·22 enrolled

Osteoarthritis1 trial

Pain Expectations in Subjects With Osteoarthritis

Completed·WWake Forest University Health Sciences·Phase 4·NCT02155257·30 enrolled

Prevention1 trial

Developing Adaptive Interventions for Cocaine Cessation and Relapse Prevention

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT02896712·118 enrolled

PK/PD1 trial

Pharmacokinetics and Pharmacodynamics (PK/PD) of CEP-26401 in Healthy Subjects

Completed· Teva logo

Teva·Phase 1·NCT01903824·40 enrolled

Biomarkers1 trial

Modafinil Effects on EEG Biomarkers of Reward and Motivation

Completed·UUniversity of California, San Diego·Phase 4·NCT03616717·23 enrolled

Medication1 trial

Stress and Medication Effects on Cocaine Cue Reactivity

Completed·MMedical University of South Carolina·Phase 2·NCT00613015·109 enrolled

Delirium1 trial

Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill

Withdrawn·—·Phase 3·NCT02028260

Cognitive impairment1 trial

Treatment for Cognitive Impairment in Depression

Withdrawn·SStanford University·Phase 3·NCT04317001

Orthostatic Hypotension1 trial

Treatment of Orthostatic Hypotension in Autonomic Failure

Completed·VVanderbilt University·Phase 1·NCT00223691·389 enrolled

Efficacy1 trial

Enhancing the Therapeutic Efficacy of Sleep Deprivation by Modafinil

Withdrawn·TTechnical University of Munich·Phase 2·NCT00670813·30 enrolled

TED1 trial

Enhancing Operational Performance in Healthy Rested Soldiers With Pharmacological Stimulants

Unknown status·UUnited States Army Aeromedical Research Laboratory·Phase 2·NCT03893032·80 enrolled

ESS1 trial

The Effect of Modafinil on Affective and Cognitive Processing

Unknown status·UUniversity of Electronic Science and Technology of China·N/A·NCT03426202·60 enrolled

Parkinson's Disease (PD)1 trial

Modafinil for Freezing of Gait (FOG) in Parkinson's Disease (PD)

Completed·UUniversity of Arkansas·Phase 2·NCT03083132·21 enrolled

Alcohol Use Disorders1 trial

Modafinil for the Treatment of Alcohol Use Disorders

Completed·TThe Mind Research Network·Phase 2·NCT03424681·12 enrolled

Addiction1 trial

Modafinil Combined With Cognitive Behavior Therapy to Treat Cocaine Addiction - 1

Completed·MMedical University of South Carolina·Phase 2·NCT00218387·123 enrolled

Sleep Restriction1 trial

The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction

Completed·—·N/A·NCT00895570·20 enrolled

Neuromodulation1 trial

Neuromodulation and Language Acquisition (Project Stage Ia)

Terminated·UUniversity Hospital Muenster·Phase 4·NCT00102284·100 enrolled

Cognition1 trial

Modafinil's Effects on Cognition in Remitted MDD

Terminated·UUnity Health Toronto·Phase 3·NCT03620253·9 enrolled

Sleep Apnea1 trial

Pharmacodynamics and Efficacy of MK-7288 in Adults With Sleep Apnea (MK-7288-010)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01092780·56 enrolled

Efficacy and Safety1 trial

Dose-Finding Study to Evaluate the Efficacy and Safety of Modafinil as Treatment for Adults With ADHD

Completed·CCephalon·Phase 2·NCT00315276·370 enrolled

Dysphagia1 trial

Identifying and Treating Arousal Related Deficits in Neglect and Dysphagia

Completed·UUniversity of Arkansas·Phase 2·NCT01085903·28 enrolled

Idiopathic Hypersomnia1 trial

Modafinil Versus Amphetamines for the Treatment of Narcolepsy Type 2 and Idiopathic Hypersomnia

Completed·EEmory University·Phase 2·NCT03772314·44 enrolled

Tinnitus1 trial

Use of Modafinil in the Treatment of Tinnitus

Terminated·UUniversity of Arkansas·Phase 1·NCT00591019·7 enrolled

Hypersomnia1 trial

RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)

Active, not recruiting·—·Phase 2·NCT06404099·361 enrolled

Sedation1 trial

Modafinil in Opioid Induced Sedation

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 3·NCT00267332·90 enrolled

Schizoaffective Disorder1 trial

Modafinil Augmentation in Chronic Schizophrenia and Schizoaffective Disorder

Withdrawn·MManhattan Psychiatric Center·Phase 2·NCT00838227

Parkinson1 trial

A Multidisciplinary Approach to Manage Gait Difficulty in Parkinson Patients

Withdrawn·UUniversity of Chicago·Phase 2·NCT02857244

Interaction1 trial

Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00033046·12 enrolled

Lung Cancer1 trial

Modafinil for the Treatment of Fatigue in Lung Cancer V9.0

Completed·UUniversity of Oxford·Phase 4·NCT00829322·208 enrolled

Methamphetamine1 trial

Assessment of Interactions Between Intravenous Methamphetamine and Modafinil - 1

Unknown status·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00265278·16 enrolled

Insomnia1 trial

The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia

Completed·UUniversity of Rochester·Phase 4·NCT00124384·40 enrolled

Primary Biliary Cirrhosis1 trial

Modafinil in the Treatment of Fatigue in Patients With Primary Biliary Cirrhosis (PBC)

Completed·MMayo Clinic·Phase 1·NCT00943176·40 enrolled

Relapse1 trial

Modafinil, Sleep Architecture and Cocaine Relapse

Completed·YYale University·Phase 2·NCT01137396·114 enrolled

Cerebral Palsy1 trial

Central Nervous System Stimulants and Physical Function in Children With Cerebral Palsy

Not yet recruiting·KKuwait University·Phase 1·NCT05675098·30 enrolled

Memory Impairment1 trial

Efficacy of Pharmacological Treatment of Working Memory Impairment After Traumatic Brain Injury: Evaluation With fMRI

Unknown status·KKessler Foundation·N/A·NCT00489892·20 enrolled

Prostate Cancer1 trial

Study With Modafinil in Patients Treated With Docetaxel-Based Chemotherapy for Metastatic Breast or Prostate Cancer (MOTIF)

Completed· Sanofi logo

Sanofi·Phase 3·NCT00917748·84 enrolled

Treatment1 trial

Modafinil Treatment for Sleep/Wake Disturbances in Older Adults

Terminated·VVA Palo Alto Health Care System·Phase 4·NCT00626210·2 enrolled

Substance Abuse1 trial

Substance Abuse Pre-Treatment Screening Study

Recruiting·TThe University of Texas Health Science Center, Houston··NCT00439049·7,500 enrolled

Humans1 trial

Effects of Methylphenidate, Modafinil, and MDMA on Emotion-processing in Humans: A Pharmaco-fMRI Study

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1·NCT01951508·24 enrolled

Adult1 trial

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults

Completed· Takeda logo

Takeda·Phase 1·NCT03522506·20 enrolled

Post-Traumatic Stress Disorder1 trial

Modafinil in the Treatment of PTSD (Posttraumatic Stress Disorder)

Unknown status·BBiomedical Research Foundation·Phase 2/3·NCT01726088·40 enrolled

Excessive Sleepiness1 trial

Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness

Completed·CCephalon·Phase 3·NCT00214968·92 enrolled

Critical Care1 trial

Modafinil for Wakefulness in the Critical Care Units

Completed·KKing Faisal Specialist Hospital & Research Center··NCT04751227·8 enrolled

Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)1 trial

Modafinil for Debilitating Fatigue in Quiescent Inflammatory Bowel Disease: a Multicentre,Randomised, Double-blind, Placebo-controlled, Clinical Trial (MODIFI-IBD Trial)

Recruiting·RRadboud University Medical Center·Preclinical·NCT07582458·60 enrolled

Cognitive1 trial

Modafinil to Improve Fatiguability (MODIFY): Modafinil vs. Placebo Vanguard RCT

Recruiting·OOttawa Hospital Research Institute·Preclinical·NCT05333250·40 enrolled

Unspecified6 trials

Pharmacological Cognitive Enhancement

Completed·—·Phase 1·NCT01684306·26 enrolled

A Clinical Study of MK-6552 and Modafinil in Healthy Men (MK-6552-005)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06665230·12 enrolled

Fasting Study of Modafinil Tablets 200 mg and Provigil® Tablets 200 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650000·32 enrolled

Show 3 more trials

Food Study of Modafinil Tablets 200 mg to Provigil® Tablets 200 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00650286·20 enrolled

Provigil (Modafinil) Study by Taiwan Biotech Co.

Completed·NNational Taiwan University Hospital·N/A·NCT00174174·30 enrolled

Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls

Completed·—·N/A·NCT02051153·64 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 24, 1998

PROVIGIL

NDA NDA020717

Sources

References

[1]
ClinicalTrials.gov — 133 trial records for Modafinil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Provigil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Modafinil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Modafinil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA020717). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Nuvo Research GmbH company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine Transporter Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: NNuvo Research GmbH