CLINICAL TRIALS PROFILE FOR MODAFINIL

505(b)(2) Clinical Trials for modafinil

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03182413 ↗	Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation	Completed	Institut de recherche biomédicale des armées (IRBA), Bretigny sur Orge, France	Phase 1	2015-09-01	Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h). Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.
New Combination	NCT03182413 ↗	Impact of THN102 on Attention, Wakefulness and Cognitive Performance During Total Sleep Deprivation	Completed	Theranexus	Phase 1	2015-09-01	Study Objectives: THN102 is a new combination between modafinil and flecainide low-dose, a documented glial connexin inhibitor. Efficacy of THN102 was compared to modafinil and to placebo on parameters impaired by total sleep deprivation (SD, lasting 40h). Methods: 20 healthy male subjects participated in a double-blind, randomised, incomplete-block 3-period cross-over trial involving 5 treatments (n=12 per group): placebo (PBO), modafinil 100 mg (MOD), and combinations THN102 (modafinil 100 mg and 1, 3 or 9 mg flecainide as THN1, THN3 and THN9), as 3 oral doses over 18h.

All Clinical Trials for modafinil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00033046 ↗	Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1	Unknown status	National Institute on Drug Abuse (NIDA)	Phase 1	2001-06-01	The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.
NCT00042848 ↗	Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer	Completed	National Cancer Institute (NCI)	Phase 3	2002-08-01	RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
NCT00042848 ↗	Modafinil in Treating Fatigue in Patients Receiving Chemotherapy for Cancer	Completed	Gary Morrow	Phase 3	2002-08-01	RATIONALE: Modafinil may be effective in relieving fatigue in patients with cancer who are undergoing chemotherapy. The effectiveness of modafinil in relieving chemotherapy-related fatigue is not yet known. PURPOSE: This randomized phase III trial is studying the effectiveness of modafinil in treating fatigue in patients who are receiving chemotherapy for cancer.
NCT00052286 ↗	Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer	Completed	Cephalon	N/A	2002-09-01	RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
NCT00052286 ↗	Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer	Completed	National Cancer Institute (NCI)	N/A	2002-09-01	RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.
NCT00052286 ↗	Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer	Completed	Jonsson Comprehensive Cancer Center	N/A	2002-09-01	RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes such as memory loss in patients who have undergone treatment for primary brain cancer. The effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet known. PURPOSE: This randomized clinical trial is comparing how well two different doses of modafinil work in treating fatigue and behavioral changes in patients who have undergone treatment for primary brain cancer.

Clinical Trial Conditions for modafinil

Condition Name

Condition Name for modafinil
Intervention	Trials
Fatigue	20
Narcolepsy	14
Healthy	14
Cocaine Dependence	12

Condition MeSH

Condition MeSH for modafinil
Intervention	Trials
Fatigue	28
Cocaine-Related Disorders	22
Sleepiness	20
Disorders of Excessive Somnolence	18

Clinical Trial Locations for modafinil

Trials by Country

Trials by Country for modafinil
Location	Trials
United States	394
Canada	15
France	7
Switzerland	5
Germany	5

Trials by US State

Trials by US State for modafinil
Location	Trials
California	31
New York	22
Texas	20
Pennsylvania	15
New Jersey	13

Clinical Trial Progress for modafinil

Clinical Trial Phase

Clinical Trial Phase for modafinil
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	4
PHASE1	2

Clinical Trial Status

Clinical Trial Status for modafinil
Clinical Trial Phase	Trials
Completed	106
Unknown status	20
Terminated	19

Clinical Trial Sponsors for modafinil

Sponsor Name

Sponsor Name for modafinil
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	21
Cephalon	20
National Institute of Mental Health (NIMH)	6

Sponsor Type

Sponsor Type for modafinil
Sponsor	Trials
Other	180
Industry	50
NIH	38

Clinical Trials Update, Market Analysis, and Projection for Modafinil

Last updated: October 28, 2025

Introduction

Modafinil, a wakefulness-promoting agent initially approved for narcolepsy, obstructive sleep apnea, and shift work sleep disorder, has garnered significant attention beyond its original indications. Its off-label use for cognitive enhancement and fatigue management has expanded the market landscape. Analyzing recent clinical trials, market developments, and future projections offers valuable insights for stakeholders. This report provides a comprehensive review of modafinil’s clinical trial activity, market dynamics, and projections up to 2030.

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Clinical Trials Update

Recent Clinical Trial Activity

Over the past five years, pharmacological research has intensified around modafinil, focusing on its potential neuroprotective effects, addiction treatment utility, and psychiatric applications. According to ClinicalTrials.gov, approximately 75 trials involving modafinil have been registered or updated since 2018, spanning across multiple therapeutic domains.

• Neurodegenerative Disorders: Multiple studies explore modafinil's role in cognitive decline associated with Alzheimer's disease and multiple sclerosis. A notable trial (NCT03655486) is evaluating its impact on fatigue and cognition in multiple sclerosis patients, with preliminary results indicating moderate benefits.

• Psychiatry and Mood Disorders: Several trials investigate modafinil as an adjunct therapy in depression (NCT03479184) and bipolar disorder (NCT04528696). Early phase results suggest symptomatic improvements, but larger, controlled studies are pending.

• Addiction and Substance Use Disorders: Investigations into modafinil as an agent for cocaine and methamphetamine dependence (NCT02234469, NCT01578726) demonstrate promising reductions in cravings and relapse rates.

• Cognitive Enhancement: Numerous trials target healthy populations for cognitive performance enhancement, including university students and military personnel. These studies primarily examine safety and efficacy, with mixed results.

Clinical Trial Outcomes and Regulatory Landscape

While extensive research exists, the heterogeneity of outcomes warrants caution. The FDA-approved indications remain the core market, but several off-label uses have prompted regulatory scrutiny. Recent submissions for expanded indications face rigorous clinical evaluation, which may influence future approval pathways.

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Market Analysis

Current Market Size and Segments

As of 2023, the global modafinil market was valued at approximately $1.8 billion, with North America leading due to high off-label use and robust healthcare infrastructure. The key segments include:

• Therapeutic Use: Narcolepsy, sleep apnea, shift work disorder.
• Off-label Use: Cognitive enhancement, fatigue management.
• Research and Clinical Trials: Expanding as a growing niche.

Market Drivers

• Increasing prevalence of sleep disorders: Rising rates of obesity and lifestyle-related sleep issues sustain demand.
• Off-label cognitive use: Growing demand in corporate, academic, and military sectors fuels market expansion.
• Pharmaceutical pipeline advancements: New formulations, including sustained-release variants, attract investment.

Competitive Landscape

Major players include Cephalon (part of Teva Pharmaceuticals), responsible for branded Provigil, and various generics manufacturers. The US FDA's approval of generic formulations increased accessibility and reduced prices, expanding user base.

Regulatory Challenges

Despite widespread off-label use, regulatory concerns persist, especially regarding non-prescribed, cognitive-enhancement applications. Countries like the UK and EU maintain strict controls, which influence market dynamics.

Market Trends and Challenges

• Efficacy debates: Disparate clinical trial results create uncertainty.
• Safety considerations: Adverse effects such as headaches and anxiety, if understated, could impact user acceptance.
• Emergence of alternatives: New wakefulness agents like armodafinil and solriamfetol provide competition.

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Market Projection and Future Outlook (2023-2030)

Forecasted Growth

The market is projected to grow at a CAGR of 6.5-8% through 2030, driven by expanding therapeutic applications and increasing off-label use. By 2030, the market value is estimated to reach $3.6 billion-$4.5 billion.

Key Drivers in Future Growth

• Expanded indications: Pending regulatory approvals for cognitive and neurodegenerative disorders could substantially boost sales.
• Innovative formulations: Introduction of longer-acting and combined formulations can enhance efficacy and compliance.
• Emerging markets: Adoption in Asia-Pacific countries presents untapped growth opportunities.

Risks and Barriers

• Regulatory restrictions on off-label use may constrain growth.
• Public health concerns over misuse may lead to tighter controls.
• The advent of novel wakefulness agents may erode market share of modafinil.

Strategic Opportunities

• Research collaborations: Partnerships with academic institutions can accelerate clinical development.
• Regulatory engagement: Early dialog with health regulators can streamline approval pathways.
• Diversification: Developing combination therapies targeting specific neuropsychiatric conditions could differentiate products.

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Key Takeaways

• Clinical trials for modafinil are expanding into neurodegenerative and psychiatric indications, though conclusive results are still emerging.
• The global modafinil market remains robust, with North America dominating due to off-label cognitive enhancement use.
• Future growth hinges on regulatory approvals for new indications, innovative formulations, and emerging markets’ adoption.
• Competitive pressures from alternative agents and regulatory scrutiny remain significant considerations.
• Strategic R&D, regulatory engagement, and market diversification are critical for stakeholders seeking sustainable growth.

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FAQs

1. What are the primary approved uses of modafinil?
Modafinil is FDA-approved for narcolepsy, obstructive sleep apnea, and shift work sleep disorder. Its off-label use for cognitive enhancement and fatigue management is widespread but not formally sanctioned by regulatory authorities.

2. Are there ongoing clinical trials investigating new indications for modafinil?
Yes, numerous trials focus on neurodegenerative diseases, depression, and substance use disorders. Results from these studies may support expanded regulatory approvals in the future.

3. How does the market for modafinil compare to its alternatives?
While modafinil remains the market leader for wakefulness agents, alternatives like armodafinil and solriamfetol are gaining traction, especially given their different patent statuses and side effect profiles.

4. What regulatory challenges could impact the future of modafinil?
Concerns over misuse, off-label prescribing, and safety issues could lead to tighter controls, influencing prescribing practices and market accessibility.

5. What factors will shape the future market landscape for modafinil?
Regulatory decisions, emerging clinical evidence, development of new formulations, and market penetration in emerging economies will be primary determinants of future growth.

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References

1. ClinicalTrials.gov. Modafinil studies. [Link]
2. MarketWatch. Global Modafinil Market Size and Forecast. [Link]
3. U.S. Food & Drug Administration. Provigil (Modafinil) Prescribing Information. [Link]
4. GlobalData. Sleep Disorder Drugs Market Report 2023. [Link]
5. European Medicines Agency. Summary of Modafinil’s Regulatory Status. [Link]