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Last update 26 Feb 2026

Modafinil

Last update 26 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryModafinil, a minuscule molecular compound marketed as PROVIGIL, received its initial approval in 1992. This drug is principally utilized to enhance vigilance among adult patients who are plagued by excessive sleepiness, a symptom of narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). However, it is important to note that PROVIGIL is not intended to treat the underlying causes of these sleep disorders; rather, its function is to heighten the patient's aptitude to remain alert during daylight hours. As a central nervous system stimulant, Modafinil operates by augmenting the activity of particular chemicals located within the brain that are implicated in regulating the sleep-wake cycle.

Drug Type

Small molecule drug

Synonyms

2-((diphenylmethyl)sulfinyl)acetamide, Alertec, Attenace

+ [25]

Target

DAT

Action

antagonists

Mechanism

DAT antagonists(Dopamine transporter antagonists)

Therapeutic Areas

Nervous System DiseasesRespiratory DiseasesOther Diseases

Active Indication

Idiopathic HypersomniaDisorders of Excessive SomnolenceNarcolepsy+ [3]

Inactive Indication

Alzheimer DiseaseApathyAttention Deficit Disorder With Hyperactivity+ [10]

Originator Organization

Teva Pharmaceuticals Europe BV

Active Organization

Tanabe Pharma Corp.Nuvo Pharmaceuticals (Ireland) DAC

Libbs Farmacêutica Ltda.

+ [3]

Inactive Organization

Cephalon, Inc.Cephalon Europe Ltd.

License Organization

Neuraxpharm

Drug Highest PhaseApproved

First Approval Date

United States (24 Dec 1998),

NarcolepsySleep Apnea, ObstructiveSleep Disorders, Circadian Rhythm+ [1]

RegulationOrphan Drug (United States), Orphan Drug (Japan)

Structure/Sequence

Molecular FormulaC15H15NO2S

InChIKeyYFGHCGITMMYXAQ-UHFFFAOYSA-N

CAS Registry68693-11-8

221

Clinical Trials associated with Modafinil

NCT07263022

/ Not yet recruitingPhase 3IIT

Cognitive Strategies in Early Psychosis 2

The goal of this clinical trial is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. Participants will be people who have had symptoms of a psychosis spectrum disorder start within the last five years. The investigators will study how two study agents change decision making in people with psychosis, by asking participants to complete some brain games on the computer before and after taking the study agents. The investigators hope to improve our understanding of psychosis to help people in the future. The main research questions are:
* Does a single dose of modafinil change how people with psychosis play the brain games?
* Does a single dose of d-serine change how people with psychosis play the brain games?
* Does a single dose of modafinil change brain activity?
* Does a single dose of d-serine change brain activity?
Participants will:
* Complete an interview and self-report questionnaires.
* Complete safety screening activities, like a blood draw, a urine drug test, and an alcohol breathalyzer test.
* Complete functional Magnetic Resonance Imaging (fMRI) scans. fMRI uses magnets to take pictures of the brain. There will be six scanning appointments in the study, with two scans each. Appointments will be about a month apart.
* Take a single dose of a study agent during each scanning appointment. The study agent will be taken after the first fMRI. There are three study agents in total: modafinil, d-serine, and a placebo. Each participant will take each study agent twice during the study.
* Play brain games on a computer that measure decision making, thinking, and problem solving skills

Start Date15 Mar 2026

Sponsor / Collaborator

University of Minnesota

[+1]

NCT07295834

/ Not yet recruitingPhase 2IIT

A Multi-centre, Double-blind Randomised Controlled Trial to Compare Modafinil Versus Placebo Over 12 Weeks in Patients With Severe Fatigue and Inflammatory Bowel Disease (MFI): a Feasibility Study

Fatigue is a big problem in people with inflammatory bowel disease (IBD). Even when IBD is well controlled, 50% of patients remain fatigued most of the time. Fatigue can be physical (e.g. feeling tired or weak) and mental (e.g. brain fog). However, there are no effective treatments for IBD fatigue.
Modafinil is a medication that can rapidly improve fatigue. It usually acts within 30 minutes and improves wakefulness. It can also improve brain fog. Modafinil has been used for over 30 years in people with narcolepsy, which is a condition where people fall asleep during the day. Modafinil has also been used in people who do not have narcolepsy.
This study will compare modafinil with a dummy tablet (placebo) in people with IBD. This is a feasibility study. This means it primarily aims to test whether a trial like this can be conducted in people with IBD.
Half of the patients in the study will receive modafinil and half will receive placebo. Treatment will be 12 weeks. Patients will start by taking 1 tablet and will then increase to 2 tablets and then 3 tablets if needed. A computer will randomly allocate treatment, meaning there is an equal chance of being allocated modafinil or placebo. They will be followed up after 6 weeks and 12 weeks.
Being a feasibility study, the investigators will measure how many patients consent to the study; how many complete treatment; and how acceptable the treatment is. Participants will complete a range of questionnaires measuring fatigue, mental health and gut health, primarily to look at the completeness and spread of data, and to obtain estimates of treatment effects and their variance.
If feasible, this study will support a larger version of the trial.

Start Date01 Feb 2026

Sponsor / Collaborator

Imperial College London

NCT05333250

/ RecruitingPhase 1/2IIT

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

Cancer-related fatigue (CRF) and cancer-related cognitive impairment (CRCI) are among the most commonly reported disabling symptoms experienced by patients with advanced cancer. However, there are currently limited evidence-based pharmacologic interventions available. The investigators will conduct a Vanguard Randomized Clinical Trial (RCT) to estimate the effect of modafinil in managing CRF and CRCI, and to test the feasibility of carrying out the study.

Start Date22 Jan 2026

Sponsor / Collaborator

Ottawa Hospital Research Institute

[+1]

100 Clinical Results associated with Modafinil

100 Translational Medicine associated with Modafinil

100 Patents (Medical) associated with Modafinil

2,077

Literatures (Medical) associated with Modafinil

01 Apr 2026·JOURNAL OF AFFECTIVE DISORDERS

A real-world pharmacovigilance study of modafinil events in the FDA Adverse Event Reporting System (FAERS)

Article

Author: Huang, Ping ; Huang, Jinlong ; Zheng, Xiaochun ; Shi, Jiana ; Zhang, Miaomiao ; Yang, Xiuli ; Zheng, Shuilian

OBJECTIVE:

This study aims to analyze adverse events (AEs) associated with modafinil based on the FAERS database to provide insights for its safety monitoring.

METHODS:

For quantifying signals of modafinil-related AEs, disproportionality analyses were employed, including the use of measures such as the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Multi-Item Gamma Poisson Shrinker (MGPS) and Bayesian Confidence Propagation Neural Network (BCPNN) algorithms.

RESULTS:

We extracted modafinil-related AE reports from the FAERS database spanning from the first quarter of 2004 to the first quarter of 2024 and conducted detailed data analysis. Out of a total of 21,035,995 case reports, 3070 were directly associated with modafinil. We identified 127 Preferred Terms (PTs) to describe these AEs, encompassing 27 organ systems. Specifically, several AEs such as stress cardiomyopathy, brain oedema, hypotonia, abortion spontaneous, premature labour, neonatal disorder, and eosinophilic myocarditis were not explicitly mentioned in the drug label, indicating potential new signals of adverse drug reactions (ADRs). The median onset time of modafinil-related AEs was 76.5 days (interquartile range [IQR] 14-392 days), with most AE cases occurring in the first month after initiation of modafinil.

CONCLUSION:

Analysis of the FAERS database identified AEs associated with modafinil, particularly diseases related to pregnancy, puerperium and perinatal conditions, as well as congenital, familial and genetic disorders and cardiac disorders that were not previously documented in the drug's official labeling. These findings underscore the need for continuous post-market surveillance among healthcare professionals and heightened awareness of potential new ADR signals.

01 Mar 2026·SLEEP MEDICINE

Circadian rest-activity rhythm in patients with narcolepsy following modafinil treatment: Outcomes and predictive markers

Article

Author: Lee, Pin-Yi ; Chu, Si-Yu ; Tang, I ; Chin, Wei-Chih ; Huang, Yu-Shu ; Roan, Tsun-Yi ; Lin, Chen

OBJECTIVES:

Hypersomnolence of narcolepsy is commonly treated with modafinil, but its impacts on circadian rhythm remain unclear. Compared with standard parametric analyses, the non-parametric analysis of actigraphy offers more details to observe sleep-wake patterns. This study monitored narcolepsy patients' rest-activity patterns before and after modafinil treatment by actigraphy. Data were analyzed with non-parametric methods to evaluate outcomes and investigate the potential predictive markers for treatment response.

METHODS:

We prospectively recruited participants with type 1 and 2 narcolepsy. Participants received 200-400 mg of modafinil daily for six months and actigraphy was worn for 7-14 days before and after treatment. We used paired sample t-tests for pre- and post-treatment comparisons and independent sample t-tests and chi-square tests to assess group differences. Correlation analyses were conducted using Pearson's correlation test.

RESULTS:

A total of 103 participants (mean age: 23.95 ± 10.14 years; 53.4 % male) were recruited, including 64 with NT1 and 39 with NT2. After modafinil treatment, significant increases in daytime activity were observed, along with an earlier shift in the midpoint time of daytime activity. Patients with NT1 showed more improvements than those with NT2. Correlation analysis showed that subjective sleepiness and quality of life were associated with circadian parameters, and patients with a higher REM percentage and those with nocturnal sleep onset REM period demonstrated greater improvements in circadian parameters.

CONCLUSION:

Modafinil improves circadian rest-activity rhythms in narcolepsy patients, especially those with NT1. The role of REM percentage and nocturnal SOREMP as predictive markers for treatment outcomes warrant further investigation.

02 Jan 2026·NEUROLOGICAL RESEARCH

Differential expression of D2 receptor isoforms in the mesocorticolimbic system after treatment with modafinil and its rewarding combination with citalopram in rats

Article

Author: Molina-Martínez, Luz M. ; Yepez, Jesús E. ; Juárez, Jorge

BACKGROUND:

Psychostimulants induce neuroplastic changes in the mesocorticolimbic system associated with the expression of the D2 receptor, which has two isoforms: D2long (D2L) and D2short (D2S). These isoforms seem to participate differentially in the plasticity changes induced by psychostimulants; however, the expression changes of this receptor induced by these substances remain unclear. Psychostimulants have a mechanism that involves the participation of monoamines, and there is evidence that the dopamine activation by modafinil (MOD) in combination with the serotonin activation by citalopram (CIT) enhances psychostimulant-like effects for this combination.

OBJETIVE:

The present study was designed to characterize the expression of the D2S, D2L isoforms and tyrosine hydroxylase in the medial prefrontal cortex, ventral tegmental area, nucleus accumbens and ventral pallidum of rats previously treated with modafinil alone or in combination with citalopram.

RESULTS:

Results show that MOD alone and co-administered with CIT induce overexpression of D2S and D2L in the ventral pallidum, and only the pretreatment with 60 mg MOD + 3 mg CIT generated a higher expression of D2L in the medial prefrontal cortex and ventral tegmental area. Tyrosine hydroxylase expression was reduced only with 60MOD +5 mg CIT in the nucleus accumbens.

CONCLUSION:

These findings suggest that MOD, alone or co-administered with CIT, produces differential changes in the D2R isoforms that coincide with the psychostimulant effects of these substances. This research highlights the importance of further exploring the expression and function of D2 receptors and their two isoforms, as such analyses will allow us to infer the pre- and post-synaptic modulation of these receptors on the reward system.

News (Medical) associated with Modafinil

08 Sep 2025

·www.prnewswire.com

Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025

E2086 Showed Potential to Improve Wakefulness in People Living with Narcolepsy Type 1 TOKYO, Sept. 8, 2025 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") announced today that the results from a Phase Ib clinical trial (NCT06462404) of its in-house developed novel selective orexin 2 receptor agonist E2086 have been presented at the World Sleep 2025 congress, held in Singapore from September 5 to 10. These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 (NT1). Continue Reading Clinical Trial Design This randomized, double-blind, single-dose, multiple crossover, Phase Ib clinical trial was conducted in the United States and Canada to evaluate the efficacy, safety, and tolerability of E2086 in people meeting criteria for NT1, compared with placebo and an existing treatment (modafinil). There were a total of 21 patients in the clinical trial (21 patients received the study medication, 19 patients completed the trial). Participants received a single dose of one of five treatments (E2086 5 mg, 10 mg, 25 mg, placebo, or modafinil) shortly after waking, efficacy assessments were conducted for each treatment. Efficacy was assessed using the objective Maintenance of Wakefulness Test (MWT)*1 to evaluate excessive daytime sleepiness (EDS), and subjective sleepiness was measured using the Karolinska Sleepiness Scale (KSS)*2 at the end of each MWT session. Clinical Trial Results As evaluated by MWT, all doses of E2086 demonstrated statistically significant longer sleep latencies*3 – a measure of the ability to stay awake – compared with placebo (P<0.0001 for all doses) and modafinil (E2086 5 mg: P=0.0009; E2086 10 mg and 25 mg: P<0.0001) (See the figure below). For the KSS, all doses of E2086 showed statistically significant higher alertness compared with placebo (P<0.0001), while E2086 10 mg and 25 mg demonstrated statistically significantly higher alertness compared with modafinil (P<0.0001). These outcomes confirmed the Proof of Mechanism for E2086. Treatment-emergent adverse events (TEAEs), based on the 21 patients who received the study medication in the clinical trial, exhibited a dose-dependent trend. The four most frequently observed TEAEs with E2086 included increased urinary frequency (E2086 5 mg: 14.3%, 10 mg: 23.8%, 25 mg: 52.4%), nausea (14.3%, 19.0%, 47.6%), dizziness (4.8%, 23.8%, 38.1%), and urinary urgency (9.5%, 19.0%, 38.1%). No participants discontinued due to TEAEs, and most TEAEs were mild to moderate in severity. No serious TEAEs were reported. Katsutoshi Ido, Ph.D., Chief Scientific Officer at Eisai, commented: "At World Sleep 2025, we presented data supporting the potential of E2086 to improve daytime wakefulness in people diagnosed with narcolepsy type 1. Narcolepsy is a condition with high unmet medical needs, characterized not only by excessive daytime sleepiness but also by symptoms such as cataplexy, hypnagogic/hynopompic hallucinations, and sleep paralysis, all of which significantly impair the quality of life of those affected. The efficacy and safety findings from this trial warrant further investigation in the narcolepsy patient population." Orexin is a neurotransmitter that plays a central role in regulating sleep and wakefulness. Inhibiting orexinergic neurons is believed to promote a natural transition from wakefulness to sleep. Conversely, activating orexinergic neurons is believed to help maintain a more stable state of wakefulness. From the perspective of inhibiting orexinergic neuron activity, Eisai has developed the insomnia treatment DAYVIGO ® (generic name: lemborexant) an orexin receptor antagonist that is available in more than 25 countries worldwide. Furthermore, leveraging the orexin platform established through the development of DAYVIGO, Eisai has created E2086, an orexin receptor agonist that activates orexinergic neurons. In addition to DAYVIGO, Eisai aims to contribute to people living with sleep disorders through the development of E2086. *1 Maintenance of Wakefulness Test (MWT): An objective test that evaluates the ability to stay awake in a sleep-conducive environment. The test is conducted in a quiet examination room with the lights turned off, consisting of four 40-minute sessions carried out at two-hour intervals throughout the day, during which the time taken to fall asleep (sleep latency) is measured using electroencephalography. *2 Karolinska Sleepiness Scale (KSS): A simple subjective scale used to assess the current intensity of sleepiness on a 9-point scale, ranging from "1 - Very clearly awake" to "9 - Very sleepy, struggling against sleepiness". *3 Sleep latency: The amount of time it takes to fall asleep. MEDIA CONTACTS: Eisai Co., Ltd. Public Relations Department, TEL: +81-(0)3-3817-5120 Eisai Europe, Ltd. EMEA Communications Department + 44 (0) 797 487 9419 Eisai Inc. (U.S.) Libby Holman + 1-201-753-1945 [Notes to editors] 1. About E2086 E2086 is Eisai's in house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Individuals with a deficiency of orexin demonstrate excessive daytime sleepiness (EDS), as exemplified by patients with narcolepsy Type 1, demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels. E2086 has the potential to improve patients' symptoms by enhancing orexin receptor activity. 2. About narcolepsy Narcolepsy is a chronic sleep disorder that is characterized by EDS. Narcolepsy is classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). Due to problems with fatigue, cognition, and persistence of residual symptoms despite treatment, disease burden for narcolepsy is high.1 References 1. Maski. K, et.al. Listening to the Patient Voice in Narcolepsy: Diagnostic Delay, Disease Burden, and Treatment Efficacy. J. Clinical Sleep Medicine. 2017, 13 (3) p419-, SOURCE Eisai Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 1

08 Sep 2025

·www.biopharmadive.com

A new class of sleep drugs draws Wall Street’s attention

Drug developers from around the world rang in a new era of sleep medicine Monday, as data from a series of clinical trials show narcolepsy can be effectively treated by amplifying a specific brain protein.That protein, called orexin-2, helps regulate important body functions like appetite, arousal and wakefulness, which has in turn made it a promising target for drug companies. Johnson & Johnson, for instance, hopes that by blocking orexin-2, its experimental medicine seltorexant can be used to combat insomnia in patients with major depression.More commonly, though, developers are looking to boost this protein to keep people with narcolepsy awake longer. The furthest along in this pursuit is Takeda Pharmaceutical with its drug oveporexton, which recently met the main and secondary goals of two late-stage clinical trials that focused on the most common, Type 1 form of narcolepsy.On Monday, at a medical conference focused on sleep therapies, Takeda presented more detailed results from these studies. In each, researchers evaluated whether oveporexton was any better than a placebo at keeping participants awake by using what Sarah Sheikh, Takedas head of global development, describes as the most boring test of all time.This Maintenance of Wakefulness Test places participants in a dark, quiet, peaceful room and measures how long it takes them to fall asleep. The exam has several rounds, with each lasting roughly 40 minutes. According to Takeda, at the start of its studies, most participants were asleep within five minutes. But 12 weeks in, those who were taking 2 mg doses of oveporexton twice daily were staying awake about 20 minutes to 25 minutes a clinically meaningful improvement.One hallmark of Type 1 narcolepsy is a loss of muscle control known as cataplexy. Takeda additionally said the median weekly rates of cataplexy decreased more than 80% for oveporexton-treated patients during its studies. The median number of days per week that patients experienced no cataplexy had also grown, from 0 to between 4 and 5.This is the first time any drug in this field has ever shown this magnitude of effect, Sheikh said in an interview ahead of the presentation.Takeda highlighted other findings as well, like that drug-treated patients reported significant improvements in their quality of life. Oveporexton was generally well tolerated, too, as researchers did not observe serious adverse events related to treatment. There were no liver toxicity issues, nor were there any signs of patients experiencing visual disturbances a potential safety concern with orexin drugs that analysts have homed in on.The most common adverse events, Takeda said, were insomnia and frequent urination, and a majority were transient.With these results in hand, the company plans to submit its drug for approval by the end of March. Jefferies analyst Stephen Barker wrote in a note to clients how the fresh data make his team increasingly confident oveporexton will dominate a market that Takeda estimates having as many as 120,000 patients in the U.S. alone.Takeda is currently well ahead of its closest competitor, and its drug, if ultimately approved, could achieve annual sales of $1 billion, according to Barker.While Takeda may have the lead, companies like Alkermes, Eisai and Centessa Pharmaceuticals are working to make up ground.At the medical conference, Alkermes gave a more in-depth look into a mid-stage study where three different doses of its once-daily drug alixorexton each beat a placebo on that Maintenance of Wakefulness Test. After six weeks, the drug-treated groups were able to stay awake for 24 to 28 minutes and were showing meaningful improvements on sleepiness and cataplexy, Alkermes said. And, as with Takedas studies, most treatment-emergent adverse events were mild or moderate.The most common adverse events were frequent or abnormal urination, insomia, excessive saliva secretion and blurred vision, though Alkermes noted how there were no clinically meaningful changes in vital signs, eye exams, or liver or kidney function.Overall, the data was good and about as expected, wrote Marc Goodman, an analyst at Leerink Partners. Goodman added that the once-daily and flexible dosing of alixorexton should be an advantage for Alkermes, as the #2 player.Eisai also presented data from an early-stage study with 21 participants, who either received a placebo, an existing medication known as modafinil, or one of three doses of the companys drug E2086. Eisai said all doses appeared to keep patients awake significantly longer in that wakefulness test. The most common treatment-emergent adverse events were dizziness, nausea, and frequent or urgent urination. None were classified as serious.Katsutoshi Ido, Eisais chief scientific officer, said in a satement the results warrant further investigation of E2086 as a potential treatment for narcolepsy.Takedas stock price had slipped 1% in U.S. trading by Monday afternoon. Eisai shares, meanwhile, rose nearly 4% on the Tokyo stock exchange, while Alkermes were down more than 6% on the Nasdaq.The Food and Drug Administration has approved a few orexin-blocking agents for insomnia. They include Merck & Co.s Belsomra, Idorsias Quviviq and Eisais Dayvigo. '

Clinical Result

08 Sep 2025

·www.drugs.com

Eisai Presents Clinical Study Results of Novel Orexin Receptor Agonist E2086 for Narcolepsy at World Sleep 2025 E2086 Showed Potential to Improve Wakefulness in People Living with Narcolepsy Type 1

September 8, 2025 -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that the results from a Phase Ib clinical trial (NCT06462404) of its in-house developed novel selective orexin 2 receptor agonist E2086 have been presented at the World Sleep 2025 congress, held in Singapore from September 5 to 10. These data demonstrate that once-daily dosing of E2086 has the potential to improve daytime wakefulness in individuals with narcolepsy type 1 (NT1). Clinical Trial Design This randomized, double-blind, single-dose, multiple crossover, Phase Ib clinical trial was conducted in the United States and Canada to evaluate the efficacy, safety, and tolerability of E2086 in people meeting criteria for NT1, compared with placebo and an existing treatment (modafinil). There were a total of 21 patients in the clinical trial (21 patients received the study medication, 19 patients completed the trial). Participants received a single dose of one of five treatments (E2086 5 mg, 10 mg, 25 mg, placebo, or modafinil) shortly after waking, efficacy assessments were conducted for each treatment. Efficacy was assessed using the objective Maintenance of Wakefulness Test (MWT) *1 to evaluate excessive daytime sleepiness (EDS), and subjective sleepiness was measured using the Modified Karolinska Sleepiness Scale (Modified KSS) *2 at the end of each MWT session. Clinical Trial Results As evaluated by MWT, all doses of E2086 demonstrated statistically significant longer sleep latencies *3 – a measure of the ability to stay awake – compared with placebo (P<0.0001 for all doses) and modafinil (E2086 5 mg: P=0.0009; E2086 10 mg and 25 mg: P<0.0001) (See the figure below). For the KSS, all doses of E2086 showed statistically significant higher alertness compared with placebo (P<0.0001), while E2086 10 mg and 25 mg demonstrated statistically significantly higher alertness compared with modafinil (P<0.0001). These outcomes confirmed the Proof of Mechanism for E2086. Treatment-emergent adverse events (TEAEs), based on the 21 patients who received the study medication in the clinical trial, exhibited a dose-dependent trend. The four most frequently observed TEAEs with E2086 included increased urinary frequency (E2086 5 mg: 14.3%, 10 mg: 23.8%, 25 mg: 52.4%), nausea (14.3%, 19.0%, 47.6%), dizziness (4.8%, 23.8%, 38.1%), and urinary urgency (9.5%, 19.0%, 38.1%). No participants discontinued due to TEAEs, and most TEAEs were mild to moderate in severity. No serious TEAEs were reported. Katsutoshi Ido, Ph.D., Chief Scientific Officer at Eisai, commented: “At World Sleep 2025, we presented data supporting the potential of E2086 to improve daytime wakefulness in people diagnosed with narcolepsy type 1. Narcolepsy is a condition with high unmet medical needs, characterized not only by excessive daytime sleepiness but also by symptoms such as cataplexy, hypnagogic/hynopompic hallucinations, and sleep paralysis, all of which significantly impair the quality of life of those affected. The efficacy and safety findings from this trial warrant further investigation in the narcolepsy patient population.” Orexin is a neurotransmitter that plays a central role in regulating sleep and wakefulness. Inhibiting orexinergic neurons is believed to promote a natural transition from wakefulness to sleep. Conversely, activating orexinergic neurons is believed to help maintain a more stable state of wakefulness. From the perspective of inhibiting orexinergic neuron activity, Eisai has developed the insomnia treatment DAYVIGO ® (generic name: lemborexant) an orexin receptor antagonist that is available in more than 25 countries worldwide. Furthermore, leveraging the orexin platform established through the development of DAYVIGO, Eisai has created E2086, an orexin receptor agonist that activates orexinergic neurons. In addition to DAYVIGO, Eisai aims to contribute to people living with sleep disorders through the development of E2086. *1 Maintenance of Wakefulness Test (MWT): An objective test that evaluates the ability to stay awake in a sleep-conducive environment. The test is conducted in a quiet examination room with the lights turned off, consisting of four 40-minute sessions carried out at two-hour intervals throughout the day, during which the time taken to fall asleep (sleep latency) is measured using electroencephalography. *2 Modified Karolinska Sleepiness Scale (Modified KSS): A simple subjective scale used to assess the current intensity of sleepiness on a 10-point scale, ranging from "1 - Extremely alert " to "10 - Extremely sleepy, falls asleep all the time”. *3 Sleep latency: The amount of time it takes to fall asleep. About E2086 E2086 is Eisai’s in house discovered novel selective orexin 2 receptor agonist. Nonclinical studies have demonstrated statistically significant increases in time spent awake and significant reductions in rates of cataplexy. Individuals with a deficiency of orexin demonstrate excessive daytime sleepiness (EDS), as exemplified by patients with narcolepsy Type 1, demonstrate a loss of orexinergic neurons, and low cerebrospinal fluid (CSF) orexin levels. E2086 has the potential to improve patients’ symptoms by enhancing orexin receptor activity. About narcolepsy Narcolepsy is a chronic sleep disorder that is characterized by EDS. Narcolepsy is classified into two subtypes, type 1 (narcolepsy with cataplexy) and type 2 (narcolepsy without cataplexy). Due to problems with fatigue, cognition, and persistence of residual symptoms despite treatment, disease burden for narcolepsy is high. 1 References 1. Maski. K, et.al. Listening to the Patient Voice in Narcolepsy: Diagnostic Delay, Disease Burden, and Treatment Efficacy. J. Clinical Sleep Medicine . 2017, 13 (3) p419-, https://jcsm-aasm-org.libproxy1.nus.edu.sg/doi/pdf/10.5664/jcsm.6494 Source: Eisai Co., Ltd.

Clinical ResultPhase 1

100 Deals associated with Modafinil

External Link

KEGG	Wiki	ATC	Drug Bank
D01832	Modafinil	N06BA07	DB00745

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Idiopathic Hypersomnia	Japan	Alfresa Pharma Corp.	21 Feb 2020
Disorders of Excessive Somnolence	Canada	Teva Pharmaceutical Industries Ltd.	24 Mar 1999
Narcolepsy	United States	Nuvo Pharmaceuticals (Ireland) DAC	24 Dec 1998
Sleep Apnea, Obstructive	United States	Nuvo Pharmaceuticals (Ireland) DAC	24 Dec 1998
Sleep Disorders, Circadian Rhythm	United States	Nuvo Pharmaceuticals (Ireland) DAC	24 Dec 1998
Sleepiness	United States	Nuvo Pharmaceuticals (Ireland) DAC	24 Dec 1998

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 3	United States	Cephalon, Inc.	01 Jul 2005
Apathy	Phase 3	United States	Cephalon, Inc.	01 Jul 2005
Cataplexy	Phase 3	United States	Cephalon, Inc.	01 Oct 2004
Cataplexy	Phase 3	Canada	Cephalon, Inc.	01 Oct 2004
Obstructive Sleep Apnea Hypopnea Syndrome	Phase 3	United States	Cephalon, Inc.	01 Oct 2004
Obstructive Sleep Apnea Hypopnea Syndrome	Phase 3	Canada	Cephalon, Inc.	01 Oct 2004
Attention Deficit Disorder With Hyperactivity	Phase 3	United States	Cephalon, Inc.	01 Sep 2003
Depressive Disorder	Phase 2	Germany	Cephalon, Inc.	01 May 2008
Sleep Deprivation	Phase 2	Germany	Cephalon, Inc.	01 May 2008
Fatigue	Phase 2	United States	Cephalon, Inc.	01 May 2004

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03772314 (Pubmed \| CNS Drugs) Manual	Phase 2	Narcolepsy \| Idiopathic Hypersomnia	-	Modafinil	yhmnmbhbdd(ebrlfjhzzb) = trzxarvmtw ngqbgeyfrh (oqvlayzupy, 2.7) Not Met View more	Negative	21 Sep 2024
				Amphetamine-Dextroamphetamine	yhmnmbhbdd(ebrlfjhzzb) = fmyidagwub ngqbgeyfrh (oqvlayzupy, 4.7) Not Met View more
NCT03621761 (COMBO-MS, ACTRIMS2023)	Phase 4	Multiple Sclerosis	336	Telephone-based Cognitive Behavioral Therapy (CBT)	xhcujxqiiz(cmpfzorspy) = mpxaaublws wvlhwzgigf (oquhdisktu, 11.9)	Positive	30 May 2023
				Modafinil	xhcujxqiiz(cmpfzorspy) = dnrmzgedkz wvlhwzgigf (oquhdisktu, 15.9)
NCT03621761 (COMBO-MS, CTgov)	Phase 4	Fatigue \| Multiple Sclerosis	343	Telephone-based Cognitive Behavioral Therapy (Cognitive Behavioral Therapy)	xeuvtujafm(firdoppqch) = ievlfnrnzm pzupoalqzn (gablmahouq, 11.9) View more	-	27 Dec 2022
				Modafinil (Modafinil)	xeuvtujafm(firdoppqch) = nmrmxteaet pzupoalqzn (gablmahouq, 15.9) View more
NCT03083132 (CTgov)	Phase 2	Mental Fatigue \| Parkinson Disease	21	modafinil 50mg (Early-start)	kncllosain(cggsgtthpc) = ijhomvdfnk mldbxovhlq (yutkeonetz, 2.53) View more	-	27 Oct 2021
				Placebo oral capsule+modafinil 50mg (Delayed-start)	kncllosain(cggsgtthpc) = xniowuycit mldbxovhlq (yutkeonetz, 1.62) View more
NCT01381718 (CTgov)	Phase 2	Cognition \| Neurotoxicity Syndromes \| Cognitive Dysfunction ... View more	112	Modafinil (Arm I - Modafinil)	tyahbulxnb(chfphyjxlb) = pgtozifbqz aretyyeffl (gjucixchgo, 0.71) View more	-	13 Aug 2021
				placebo (Arm II - Placebo)	tyahbulxnb(chfphyjxlb) = zlhxhkolzd aretyyeffl (gjucixchgo, 1.06) View more
NCT03185065 (TRIUMPHANT-MS, CTgov)	Phase 3	Fatigue \| Multiple Sclerosis	141	placebo (Placebo)	gizheyvoex(rwzojtxcxd) = gjpgnzewcs gxsfcxvpep (foirkdkfva, aogqaiixyv - ezvsbvrhvr) View more	-	19 Oct 2020
				Amantadine (Amantadine)	gizheyvoex(rwzojtxcxd) = lylewkzinj gxsfcxvpep (foirkdkfva, lsqdbaswev - jhgedgcrje) View more
NCT03424681 (CTgov)	Phase 2	Alcohol Use Disorder	12	Modafinil (Modafinil)	xcblwsoovc(ngjzxyxciq) = afchmdreej oluvnkrnzn (ufncwfwzjm, 27) View more	-	26 May 2020
				Placebo (Placebo)	xcblwsoovc(ngjzxyxciq) = xnzoyngrga oluvnkrnzn (ufncwfwzjm, 32) View more
NCT01913327 (APD, CTgov)	Phase 4	Schizoaffective disorder \| Schizophrenia	4	Aripiprazole+Modafinil (Aripiprazole)	huthidppnx(dusivzdizd) = qxekpllodl gadqbfnlly (bgqyrfhqxu, kguunhkrda - edpwitecty) View more	-	20 Apr 2020
				risperidone+Modafinil (Risperidone)	huthidppnx(dusivzdizd) = seixvoctut gadqbfnlly (bgqyrfhqxu, pmqqbvtivn - jszgfklgom) View more
WSC2019	Not Applicable	Sleep Apnea, Obstructive	1,714	Solriamfetol 150 mg	werumaolyd(ihvndkbfrx) = xfzoumwtqn ygapqvpoif (nkmivubmoz, 3% - 64%)	Positive	20 Sep 2019
NCT02494102 (ModOSA, CTgov)	Phase 4	Sleep Apnea, Obstructive \| Anesthesia \| Emergence Delirium	105	Placebo (Placebo)	yhzctoclal(bzbgdderoy) = rvaxhksauw clrwkgrysb (xvxmgmfqjg, dwopgkbbnu - fnfqapfyjt) View more	-	20 Jun 2019
				Modafinil (Intervention)	qhjzawhiti(ucsjhibxkg) = wuwzztpwat jqppkjfjmc (vswljhcekw, nteyptzyhw - gxluxwpzpp) View more

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