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Last update 23 Nov 2025

Modafinil

Last update 23 Nov 2025

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

Mitsubishi Tanabe Pharma Corp.

Teva Pharmaceutical Industries Ltd.

Xiangbei Welman Pharmaceutical Co., Ltd.

+ [3]

Inactive Organization

Cephalon, Inc.

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

214

Clinical Trials associated with Modafinil

NCT07231497

/ Not yet recruitingPhase 3IIT

Cognitive Strategies in Early Psychosis 1

The goal of this clinical is to learn more about decision making in psychosis spectrum disorders, like schizophrenia. The investigators will ask people who do not have psychosis to take a single dose of modafinil and then complete some brain games on the computer that measure decision making. They 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 play the brain games? Does a single dose of modafinil 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.
Take a single dose of modafinil. Complete brain games while wearing an electroencephalography (EEG) cap, before and after taking the single dose of modafinil. EEG measures electrical activity in the brain.

Start Date01 Dec 2025

Sponsor / Collaborator

University of Minnesota

[+1]

NCT06354985

/ Not yet recruitingPhase 3IIT

Modafinil and Exercise for Post Stroke Fatigue (MODEX)

A stroke happens when blood flow to the brain is stopped and the brain gets damaged. At least half of people with a stroke have fatigue months and even years later. A lot of people report fatigue as one of the worst symptoms post stroke that can affect daily activities and the length and quality of life. Though all the reasons for fatigue after stroke and how to best treat it are not fully understood, the investigators think that fatigue results from the stroke changing the brain, reducing physical fitness, and decreasing muscle strength. A stroke can also affect sleep and mood, which can impact how people feel too. It is also not known why women experience more fatigue than men after a stroke.
Some studies have tested a drug called Modafinil for post stroke fatigue, while other studies have tested exercise for it. Yet, there is unclear evidence for either treatment, so this study has the following aim:
1. Test if Exercise plus Modafinil is better than Exercise plus a Sugar Pill
This study will take place at up to 6 Canadian research sites to give a good representation of people after a stroke. Each person will be tested on fatigue, mood, fitness, thinking skills, sleep, and usual activity levels.
Participants will be assigned at random (like flipping a coin) to 1 of 2 groups:
1. Sugar Pill plus Exercise
2. Modafinil plus Exercise
The treatment will last 8 weeks. The Modafinil or Sugar Pill will be taken once a day. The exercise will be delivered virtually by a trained therapist over computer to people at home 3 times a week. Change in fatigue, quality of life, and other outcomes will be measured over 6 months.
The investigators will assess the results to identify the best treatment for post stroke fatigue and hope to be able to find a treatment that will help reduce fatigue and improve quality of life after a stroke.

Start Date01 Sep 2025

Sponsor / Collaborator

University Health Network

NCT05333250

/ Not yet recruitingPhase 3IIT

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 Date01 Jan 2025

Sponsor / Collaborator

Ottawa Hospital Research Institute

[+2]

100 Clinical Results associated with Modafinil

100 Translational Medicine associated with Modafinil

100 Patents (Medical) associated with Modafinil

2,299

Literatures (Medical) associated with Modafinil

01 Dec 2025·Neurology-Clinical Practice

Pregnancy and Fetal Outcomes Following Prenatal Exposure to Modafinil and/or Armodafinil

Article

Author: Benjamin, Daniel K. ; Parsley, Lea ; Robinson, Christopher ; Carneal-Frazer, Nicole ; Kaplan, Sigal ; Braverman, Debra L. ; Albano, Jessica D.

Background and Objectives:

An interim analysis of the modafinil/armodafinil Pregnancy Exposure Registry (PER) revealed a potential increased risk of major congenital malformations (MCMs) associated with maternal exposure to these products. To further investigate this safety signal, a 14-year safety update was conducted using the final PER data. The aim of this study was to evaluate pregnancy and fetal outcomes associated with modafinil/armodafinil exposure.

Methods:

This was a prospective, observational longitudinal cohort study conducted from 2010 to 2024. Women exposed to modafinil/armodafinil during pregnancy or within 6 weeks before becoming pregnant were included. Women enrolled before the knowledge of pregnancy outcome or birth defect detection were classified as prospective, whereas those enrolled after such knowledge were classified as retrospective. MCMs were adjudicated and classified based on the Metropolitan Atlanta Congenital Defects Program (MACDP). Descriptive statistics were used to analyze pregnancy outcomes including births, spontaneous abortions, elective terminations, fetal death, neurodevelopmental abnormalities, low/very low birth weight (LBW/very LBW), small for gestational age (SGA), and intrauterine growth restriction. Follow-up growth measurements were evaluated. MCM prevalence was compared with the MACDP population-based rate.

Results:

A total of 191 pregnancies (83.2% prospective and 16.8% retrospective) were enrolled. The mean maternal age was 31 years (SD = 4.5), and 182 (95.3%) had exposure during the first trimester. Outcomes were known for 179 pregnancies (93.7%). Among 156 prospective fetuses with known outcomes (83.0%), 137 (87.8%) resulted in live births, 17 (10.9%) in spontaneous abortions, and 2 (1.3%) in elective terminations. Among prospective live births, the prevalence of MCM was 13.1% (18/137, 95% CI, 8.0-20.0) overall and 13.7% after first trimester exposure, compared with the MACDP population-based rate of 3%. Other reported outcomes included 23 (16.8%) minor congenital malformations, 14 (10.2%) preterm births, 3 (2.2%) cases of IUGR, and 11 (8.0%) cases of LBW/VLBW; all were within the expected range of background rates. SGA was not reported. Growth parameters were within normal limits.

Discussion:

This 14-year prospective study of pregnant women exposed to modafinil/armodafinil reveals a higher prevalence of MCMs among live births compared with the general population. The study limitations and conflicting results across the literature highlight the need for future research to further investigate the potential teratogenic risks of modafinil/armodafinil.

01 Nov 2025·NAUNYN-SCHMIEDEBERGS ARCHIVES OF PHARMACOLOGY

Repurposing of modafinil as an anti-inflammatory drug: a systematic review of experimental studies

Article

Author: Ala, Moein ; Seighali, Niloofar ; Dehpour, Ahmad Reza ; Arabazadeh Bahri, Razman ; Amini, Mohammad Javad ; Mohammad Jafari, Razieh

Previous studies suggested the anti-inflammatory properties of modafinil. This study aimed to review the current literature to provide a comprehensive insight into the anti-inflammatory uses of modafinil in experimental studies. We conducted a systematic search using Medline (via PubMed), Web of Science, Scopus, and Embase databases from their commencement until 10 October 2022. All original articles focusing on modafinil anti-inflammatory effects were included. Our initial search yielded 1398 articles. Fourteen publications were included in our systematic review. Recent studies attempted to provide evidence for repurposing modafinil for several diseases, including autoimmune encephalomyelitis, nonalcoholic liver disease, gastric mucosal injury, neuropathic pain, atherosclerosis, intestinal ischemia, pulmonary hypertension, pancreatitis, ischemic stroke, testicular torsion, and lithium-pilocarpine-induced status epilepticus. Current evidence supports that modafinil can modulate inflammation, suppress the immune response, and improve disease severity partly by inhibiting NF-κB, NOS, Kca3.1, Kca2.3, and COX-2. By reviewing recent findings from experimental studies, we discussed the beneficial effects of modafinil on several inflammatory diseases, with a particular focus on the underlying mechanisms.

01 Nov 2025·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Controlled API crystallization during additive manufacturing of solid dosage form for flexible integrated pharmaceutical manufacturing

Article

Author: Duconge, Jorge ; Romañach, Rodolfo J ; Stelzer, Torsten ; Cersonsky, Rose K ; Mbodji, Aliou ; Cruz, Kelitsha Mulero ; Gómez, Andrea Arroyo ; Coquerel, Gérard ; Vlaar, Cornelis P ; Monbaliu, Jean-Christophe M ; Yu, Lian ; Zhang, Geoff Gz

Conventional manufacturing of solid dosage forms (e.g., tablets, capsules) demands multiple unit operations and handling of solids, known to be more challenging than handling liquids. To circumvent these challenges, this study explored liquid dispensing to manufacture an oral solid dosage form. The presented additive manufacturing process dispenses a solution (drug substance, solvent, polymer) into a carrier (capsule). Upon controlled solvent evaporation, the model active pharmaceutical ingredient, racemic modafinil (MOD), crystallizes inside a polymer matrix (polyethylene glycol) generating a crystalline solid dispersion. The critical process parameters (e.g., temperature, concentration, evaporation rate, choice of solvent) and key performance metrics were evaluated to ensure robust crystalline solid dispersion manufacturing. The coupled crystallization and formulation process delivers the desired polymorph form I of MOD inside a crystalline solid dispersion that matches the quality attributes of commercially formulated MOD tablets (Provigil®) following US Pharmacopeia methods. Moreover, the developed workflow and insights presented provide a generalizable approach applicable to other drug substance - polymer - solvent systems, independent if crystalline or amorphous solid dispersion is needed. Ultimately, this study demonstrates the flexible (additive) formulation of solid dosage forms, needed for, e.g., point-of-use manufacturing in remote areas or personalized medicine via a process intensification approach.

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

07 Jan 2025

·www.prnewswire.com

Neuraxpharm to further grow branded business with the acquisition of two leading narcolepsy treatments, Provigil® and Nuvigil®

Provigil® (modafinil) and Nuvigil® (armodafinil), two of the most trusted and widely prescribed brands in the narcolepsy category, will increase Neuraxpharm's global CNS presence and support market entry into new territories including Australia BARCELONA, Spain and DÜSSELDORF, Germany, Jan. 7, 2025 /PRNewswire/ -- Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, announces today that it has acquired at the end of December 2024 Provigil® (modafinil) and Nuvigil® (armodafinil), both of which are indicated for the treatment of Excessive Daytime Sleepiness (EDS) in adults with narcolepsy. Neuraxpharm has acquired these products in most markets outside the US^. Provigil's main market is Europe, with significant sales in France, Spain and Italy. Nuvigil is present in international markets with significant sales in Australia and Mexico. Both Provigil and Nuvigil are orally administered CNS stimulants indicated to improve wakefulness and reduce Excessive Daytime Sleepiness (EDS) in adult patients with narcolepsy, both with and without cataplexy. This acquisition is in line with Neuraxpharm's strategy to grow strong CNS brands and bring them to increasing numbers of patients worldwide. It will enable entry into new territories such as Australia, where Neuraxpharm also plans to launch first-in-class multiple sclerosis treatment ublituximab (BRIUMVI®), and will furthermore reinforce Neuraxpharm's presence in Mexico, where the Company established an office in 2023. The transaction follows the acquisition from Sanofi of two established product portfolios in 2023 and the securing of a landmark partnership with TG Therapeutics also in 2023 to commercialise ublituximab outside the US*. In 2020, Neuraxpharm acquired market-leading child epilepsy treatment Buccolam® (oromucosal midazolam) from Takeda, and in September last year Neuraxpharm received a positive CHMP opinion from the European Medicine Agency to extend Buccolam's indication to include the treatment of epilepsy in adults. Dr. Jörg-Thomas Dierks, CEO of Neuraxpharm, commented: "Today's acquisition is an example of how Neuraxpharm can harness its neurology-focused approach, broad international platform and entrepreneurial capabilities to expand strong CNS brands. These two leading narcolepsy treatments will be added to our broad and growing CNS portfolio. We will leverage our specialisation and reach to grow these products in existing and new markets, thereby bringing market-leading treatments to more CNS patients with unmet needs around the world." No financial details of the transaction have been disclosed. ^ Republic of Korea, Japan, Thailand and the United States are not included in this acquisition. * Territories outside the United States, Canada, Mexico, and excluding certain Asian countries previously partnered. About the Neuraxpharm Group Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 35 years. Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline, partnerships, and acquisitions. The company has c.1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira. Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratorios Lesvi) in Spain. For more information, please visit SOURCE Neuraxpharm WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalAcquisitionClinical Result

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	cugaevsjuf(nxhsvesufz) = sjzopltvmw dqumlzdtab (mnscyrnmsg, 2.7) Not Met View more	Negative	21 Sep 2024
				Amphetamine-Dextroamphetamine	cugaevsjuf(nxhsvesufz) = gidsellpec dqumlzdtab (mnscyrnmsg, 4.7) Not Met View more
NCT03621761 (COMBO-MS, ACTRIMS2023)	Phase 4	Multiple Sclerosis	336	Telephone-based Cognitive Behavioral Therapy (CBT)	nmucrlgyvo(mhkowjplmm) = hwztgpnnfw xtwrbpdhzy (ohjlnscbvy, 11.9)	Positive	30 May 2023
				Modafinil	nmucrlgyvo(mhkowjplmm) = rcgwlatuco xtwrbpdhzy (ohjlnscbvy, 15.9)
NCT03621761 (COMBO-MS, CTgov)	Phase 4	Fatigue \| Multiple Sclerosis	343	Telephone-based Cognitive Behavioral Therapy (Cognitive Behavioral Therapy)	lconrensgl(iihafwewcw) = ruwqjcfamh cawearuzni (ncegesbzrb, 11.9) View more	-	27 Dec 2022
				Modafinil (Modafinil)	lconrensgl(iihafwewcw) = qkhaoheyhx cawearuzni (ncegesbzrb, 15.9) View more
NCT03083132 (CTgov)	Phase 2	Mental Fatigue \| Parkinson Disease	21	modafinil 50mg (Early-start)	xghzamusxv(zwikeiboco) = ycrpbsusck azlospxgrh (bhioyfmzfb, 2.53) View more	-	27 Oct 2021
				Placebo oral capsule+modafinil 50mg (Delayed-start)	xghzamusxv(zwikeiboco) = mckprfmxyo azlospxgrh (bhioyfmzfb, 1.62) View more
NCT01381718 (CTgov)	Phase 2	Cognition \| Neurotoxicity Syndromes \| Cognitive Dysfunction ... View more	112	Modafinil (Arm I - Modafinil)	cwfuxbjfuq(hadfokmxmo) = oioblkxxtf wkmxrueiad (lbwwwroqox, 0.71) View more	-	13 Aug 2021
				placebo (Arm II - Placebo)	cwfuxbjfuq(hadfokmxmo) = bbkzofhopn wkmxrueiad (lbwwwroqox, 1.06) View more
NCT03185065 (TRIUMPHANT-MS, CTgov)	Phase 3	Fatigue \| Multiple Sclerosis	141	placebo (Placebo)	dubgqewlju(ewgunhmpbj) = suudetkdmn pdxoobxpwj (sugknpvlcs, hjazythmbz - eqwdbfqtjs) View more	-	19 Oct 2020
				Amantadine (Amantadine)	dubgqewlju(ewgunhmpbj) = xmpujknuxa pdxoobxpwj (sugknpvlcs, lirqooqqex - ibsehiunai) View more
NCT03424681 (CTgov)	Phase 2	Alcohol Use Disorder	12	Modafinil (Modafinil)	ncnyzmbkiy(qrbfqqnxil) = tsbvuffcyn vvhfnuwuta (unwygfhovm, 27) View more	-	26 May 2020
				Placebo (Placebo)	ncnyzmbkiy(qrbfqqnxil) = waskbeyvwr vvhfnuwuta (unwygfhovm, 32) View more
NCT01913327 (APD, CTgov)	Phase 4	Schizoaffective disorder \| Schizophrenia	4	Aripiprazole+Modafinil (Aripiprazole)	flfxmhktez(jlqagtkyke) = fohuobwifr dmmljfjrge (kovwkzxkgo, rwaktjpxbx - uecaygeorw) View more	-	20 Apr 2020
				risperidone+Modafinil (Risperidone)	flfxmhktez(jlqagtkyke) = nkfgwmzwod dmmljfjrge (kovwkzxkgo, iclnziojdx - sneympgjcz) View more
WSC2019	Not Applicable	Sleep Apnea, Obstructive	1,714	Solriamfetol 150 mg	usgipzendf(yoyeenhapq) = bxrwgwrxdw zvyqmsfwus (jpfpkxwexb, 3% - 64%)	Positive	20 Sep 2019
NCT02494102 (ModOSA, CTgov)	Phase 4	Sleep Apnea, Obstructive \| Anesthesia \| Emergence Delirium	105	Placebo (Placebo)	rbsjjqoqon(btardttwxz) = wxoncockif ayvrstbvgi (tcolwdkife, qdgpoxscuh - fcbxcgxsxw) View more	-	20 Jun 2019
				Modafinil (Intervention)	fqknwmhebp(pocsnkbjya) = qczkdrlqfb ahnxqukobq (tnzuyinsxy, nepkfslfof - zaaubdzsed) View more

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