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 51 indications[4].[1]
Provigil is one of 1055 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Approved.
51
Indications
132
Total Trials
11
Active Trials
1,054
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 49 indications
Competition
Competitive Landscape
1399 competitors in Prostate Cancer
#DrugCompanyPhaseTrials
1Provigil
NNuvo Research GmbH
Approved
Mekinist
NovartisPreclinical
Trexall
Alnylam PharmaceuticalsPreclinical
Viagra
VViatris Specialty LLC
Preclinical
Duragesic
CCephalon
Preclinical
Ranexa
MMenarini International Operations Luxembourg SA
Preclinical
Osmitrol
BB. Braun Medical Inc.
Preclinical
Precedex
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Preclinical
Statin
Bristol-Myers SquibbPreclinical
Sonovue
BBracco Diagnostics, Inc
Preclinical
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
A Randomized, Placebo-Controlled Trial of Modafinil for Methamphetamine Dependence
Completed·—·Phase 2·NCT01354470·72 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
Cocaine Dependence9 trials
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
Schizophrenia7 trials
Show 4 more trials
Obstructive Sleep Apnea4 trials
72 more indications
Multiple Sclerosis3 trials
Narcolepsy3 trials
Sleep3 trials
RECOVER-SLEEP: Platform Protocol
Completed·—·Phase 2·NCT06404086·830 enrolled
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
Effectiveness2 trials
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
Bipolar Disorder1 trial
Humans1 trial
Electroencephalography1 trial
Attention Deficit Hyperactivity Disorder1 trial
Satisfaction1 trial
Efficacy and Safety1 trial
Idiopathic Hypersomnia1 trial
Morphine1 trial
Palliative Morphine With or Without Concurrent Modafinil
Unknown status·—·Phase 3·NCT01766323·200 enrolled
Primary Biliary Cirrhosis1 trial
Memory Impairment1 trial
Hypersomnia1 trial
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
Active, not recruiting·—·Phase 2·NCT06404099·361 enrolled
Schizoaffective Disorder1 trial
Adult1 trial
Adolescent1 trial
Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Completed·—·Phase 1·NCT00258479·24 enrolled
Brain Cancer1 trial
Methamphetamine1 trial
Insomnia1 trial
Bariatric Surgery1 trial
Cognitive Functions1 trial
Cerebral Palsy1 trial
Prostate Cancer1 trial
Sedation1 trial
Modafinil in Opioid Induced Sedation
Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 3·NCT00267332·90 enrolled
Delirium1 trial
Modafinil Versus Placebo for Hypoactive Delirium in the Critically Ill
Withdrawn·—·Phase 3·NCT02028260
Safety and Efficacy1 trial
Sleep Restriction1 trial
The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
Completed·—·N/A·NCT00895570·20 enrolled
Excessive Sleepiness1 trial
Post-Traumatic Stress Disorder1 trial
Driving1 trial
Apathy1 trial
Treatment of Apathy in Alzheimer's Disease With Modafinil
Completed·—·Phase 3·NCT01172145·22 enrolled
Advanced Solid Tumors1 trial
Interaction1 trial
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
Unspecified6 trials
Pharmacological Cognitive Enhancement
Completed·—·Phase 1·NCT01684306·26 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