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 650 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.
33
Indications
137
Total Trials
15
Active Trials
649
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 32 indications
Competition
Competitive Landscape
199 competitors in Lung Cancer
#DrugCompanyPhaseTrials
1Imfinzi
AstraZenecaPhase 3
Yervoy
Bristol-Myers SquibbPhase 3
Provigil
NNuvo Research GmbH
Approved
Abraxane
Bristol-Myers SquibbPhase 3
Tecentriq
RochePhase 3
Imjudo
AstraZenecaPhase 3
Alunbrig
TakedaPhase 3
Zepzelca
Jazz PharmaceuticalsPhase 3
Tarlatamab-Dznl
AmgenPhase 3
Lynparza
AstraZenecaPhase 3
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Fatigue11 trials
Show 8 more trials
Modafinil to Treat Fatigue in Post-Polio Syndrome
Terminated·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00067496·30 enrolled
Methamphetamine Dependence9 trials
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
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Completed·—·Phase 2·NCT01354470·72 enrolled
Cocaine Dependence9 trials
Modafinil - Escitalopram Study for Cocaine Dependence
Completed·—·Phase 1·NCT01601730·68 enrolled
Show 6 more trials
Complementary Combination Therapy for Cocaine Dependence
Completed·—·Phase 1·NCT02538744·45 enrolled
Schizophrenia7 trials
Obstructive Sleep Apnea4 trials
75 more indications
Sleep4 trials
RECOVER-SLEEP: Platform Protocol
Completed·—·Phase 2·NCT06404086·830 enrolled
Show 1 more trial
Modafinil to Optimize the Performance of Cold-Stressed Sleep-Deprived Personnel
Recruiting·UUnited States Army Research Institute of Environmental Medicine·Approved·NCT07830056·33 enrolled
Narcolepsy3 trials
Multiple Sclerosis3 trials
Effectiveness2 trials
Attention2 trials
Cognitive Function2 trials
Memory2 trials
Excessive Daytime Sleepiness2 trials
Brain Injury2 trials
Study of Modafinil to Treat Fatigue in Persons With Traumatic Brain Injury
Completed·—·Phase 1·NCT00702637·60 enrolled
Depression2 trials
Modafinil for Atypical Depression
Completed·—·Phase 2/3·NCT00215176·65 enrolled
Improving Therapeutic Learning in Depression: Proof of Concept
Completed·—·Phase 2·NCT02376257·36 enrolled
AIN2 trials
Primary Biliary Cirrhosis1 trial
Cerebral Palsy1 trial
Memory Impairment1 trial
Prostate Cancer1 trial
Humans1 trial
Sleep Restriction1 trial
The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
Completed·—·N/A·NCT00895570·20 enrolled
Efficacy and Safety1 trial
Idiopathic Hypersomnia1 trial
Morphine1 trial
Palliative Morphine With or Without Concurrent Modafinil
Unknown status·—·Phase 3·NCT01766323·200 enrolled
Bariatric Surgery1 trial
Driving1 trial
Cognitive Functions1 trial
Apathy1 trial
Treatment of Apathy in Alzheimer's Disease With Modafinil
Completed·—·Phase 3·NCT01172145·22 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
Adult1 trial
Post-Traumatic Stress Disorder1 trial
Excessive Sleepiness1 trial
Delirium1 trial
Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill
Withdrawn·—·Phase 3·NCT02028260
TED1 trial
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
Adolescent1 trial
Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Completed·—·Phase 1·NCT00258479·24 enrolled
Brain Cancer1 trial
Interaction1 trial
Bipolar Disorder1 trial
Electroencephalography1 trial
Safety and Efficacy1 trial
Attention Deficit Hyperactivity Disorder1 trial
Satisfaction1 trial
Advanced Solid Tumors1 trial
Methamphetamine1 trial
Insomnia1 trial
Major Depression1 trial
Mitochondrial Disease1 trial
Unspecified6 trials
Neurochemical Modulation Cognitive Performance and Subjective Wellbeing In Healthy Controls
Completed·—·N/A·NCT02051153·64 enrolled
Show 3 more trials
Regulatory
FDA Approval Timeline[5]
Dec 24, 1998
PROVIGIL
NDA NDA020717
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Provigil drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Modafinil. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Dopamine Transporter Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- NNuvo Research GmbH