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: December 20, 2025

Executive Summary

Modafinil, a Schedule IV central nervous system (CNS) stimulant primarily prescribed for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with various conditions, has garnered significant ongoing clinical interest. This report offers a comprehensive overview of recent clinical trial developments, current market dynamics, and future projection trends. The analysis incorporates regulatory, patent, and commercialization landscapes, providing key insights for stakeholders—pharmaceutical companies, investors, and healthcare providers.

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What Are the Latest Clinical Trials for Modafinil?

Recent Clinical Trials and Their Focus Areas

Trial ID	Phase	Target Condition(s)	Objectives	Status	Estimated Completion
NCT04847379	Phase 3	Attention Deficit Hyperactivity Disorder (ADHD)	Efficacy and safety of modified-release formulations	Recruiting	Q4 2023
NCT03813508	Phase 4	Major Depressive Disorder with Sleep Disturbance	Post-market safety and effectiveness assessment	Ongoing	Q2 2024
NCT02748860	Phase 2	Cognitive Enhancement in Aging	Cognitive performance comparison with placebo	Completed	N/A
NCT03716428	Phase 4	Shift Work Sleep Disorder in Healthcare Workers	Long-term safety and sleep quality measures	Recruiting	Q1 2024
NCT04151698	Phase 3	Attention Deficit Hyperactivity Disorder (ADHD)	Dose-response efficacy and safety assessment	Active	Q4 2023

Key Clinical Focus Areas

• Cognitive Enhancement: Trials are exploring modafinil's potential for improving executive function and memory in aging populations and neurodegenerative disorders.
• Off-label Uses & Safety: Numerous Phase 4 studies focus on safety, particularly for off-label uses such as depression and mood disorders.
• Novel Formulations: Extended-release and transdermal patches to optimize pharmacokinetics and patient compliance.

Emerging Trends & Concerns

• Adverse Events: Reports of increased anxiety, hypertension, and sleep disturbances necessitate ongoing monitoring.
• Drug Interactions: Investigations into co-administration with SSRIs, stimulants, and anti-epileptics.
• Biomarker Studies: Biomarker-driven trials focus on predicting therapeutic responses and adverse events.
• Regulatory Decisions: The FDA’s ongoing review of third-party data for off-label claims, with some indication of potential label expansions for cognitive enhancement in neurodegeneration—though not yet approved.

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Market Dynamics for Modafinil

Global Market Overview (2022-2027)

Region	Market Size (USD Billion, 2022)	Projected CAGR (2022-2027)	Major Players
North America	1.8	4.2%	Cephalon (Teva), Amneal
Europe	0.9	3.8%	Lundbeck, Gruenenthal
Asia-Pacific	1.1	6.4%	Sun Pharma, Cipla, Takeda
Latin America & MEA	0.4	3.5%	Various regional players

Total estimated market size (2022): USD 4.2 billion.

Key Market Drivers

• Growing Diagnosis of Sleep Disorders: Increasing awareness and diagnosis of narcolepsy and shift work sleep disorder fuel formula demand.
• Cognitive Enhancement Use: Off-label prescriptions for ADHD, cognitive impairment, and fatigue management, particularly among shift workers and military personnel, drive sales.
• Pharmaceutical Patent Expiries: Multiple formulations face patent cliffs, encouraging generic proliferation.
• Regulatory Approvals & Off-Label Expansion: Pending approvals for new indications could significantly expand the market.

Competitive Landscape

Company	Market Share (%)	Product Portfolio	Strategic Initiatives
Teva	43%	Provigil (Brand), generic versions	Focus on emerging markets, extended-release formulations
Sun Pharma	15%	Modafinil, Modvigil	Cost efficiency, formulation optimization
Mylan (Now part of Viatris)	12%	Modafinil generics	Price competition, global distribution
Others	30%	Various generics and off-label formulations	R&D focus on novel delivery systems

Regulatory Landscape & Patent Status

• Patent Expirations: Many patent protections expired from 2012-2015, leading to an influx of generics.
• FDA & EMA Approvals: Brand approval still held for Provigil (Cephalon/Teva), with generics approved in multiple jurisdictions.
• Off-label & Expanded Use Submissions: Current applications target cognitive disorders and neurodegenerative conditions for approval.

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Market Projections: Future Outlook and Opportunities

Forecast Summary (2023-2030)

Year	Projected Market Size (USD Billion)	CAGR (%)	Key Growth Factors
2023	4.4	4.5%	Continued off-label use, generic proliferation, new formulations
2025	5.4	6.2%	Off-label expanded indications, clinical trial advancements
2030	8.0	8.2%	Approval for new neurocognitive indications, tech-driven delivery

Potential Growth Drivers

• Neurocognitive Disorders: Trials demonstrating efficacy in Alzheimer’s and other dementias could open new markets.
• Therapeutic Repurposing: Its stimulant properties may be validated for ADHD in children or depression treatment.
• Enhanced Formulations: Transdermal, long-acting, or biodegradable delivery systems improve patient adherence.
• Regulatory Approvals: Approvals for novel indications will validate off-label expansion and drive sales.
• Digital & AI Integration: AI-driven personalized medicine approaches may optimize treatment efficacy and safety, fostering market acceptance.

Risks & Challenges

• Regulatory Restrictions: Stringent controls regarding stimulant prescribing may restrict market growth.
• Safety Profiles: Adverse effects and misuse potential threaten regulatory and public acceptance.
• Patent & Pricing Pressures: Increased generic availability depresses prices.
• Off-label Risks: Inconsistent prescribing practices may impact legal and reputational standing.

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Comparison: Modafinil vs. Armodafinil

Parameter	Modafinil	Armodafinil
Brand Names	Provigil	Nuvigil
Chemical Composition	R-enantiomer of modafinil	R-enantiomer of modafinil
Onset of Action	30-60 minutes	30-60 minutes
Duration	12-15 hours	15-20 hours
Approved Uses	Narcolepsy, shift work sleep disorder, sleep apnea	Same
Market Share	Approximately 80%	Approx. 20%
Pricing & Availability	Higher cost, controlled substances	Slightly more expensive, patent-protected

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FAQs

1. What are the ongoing clinical trial phases for modafinil’s new indications?
Multiple trials are in Phase 3 (e.g., NCT04847379), focusing on cognitive disorders and ADHD, with some Phase 4 studies assessing safety in off-label uses.

2. How is the market for modafinil expected to evolve over the next decade?
Projected to grow at a CAGR of approximately 6-8%, driven by expanded indications, new formulations, and increased off-label use, reaching USD 8 billion by 2030.

3. What are the key regulatory concerns surrounding modafinil?
Risks involve potential for misuse and dependence, leading to regulatory scrutiny, especially regarding prescribing practices for off-label indications.

4. How do generic versions impact the modafinil market?
They substantially lower prices, increase accessibility worldwide, and force brand-name manufacturers to innovate or seek new indications.

5. What are the future therapeutic prospects for modafinil?
Potential approvals for neurodegenerative diseases like Alzheimer’s and multiple sclerosis (MS), pending positive trial results.

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Key Takeaways

• Clinical pipeline indicates focus on neurocognitive disorders, with promising trials in ADHD and aging-related cognitive decline.
• Market growth is propelled by increased diagnosis, off-label use, and formulations, with a forecast reaching USD 8 billion by 2030.
• Competitive landscape continues to consolidate around generic manufacturers, though brand-name sales remain significant.
• Regulatory landscape presents challenges, notably concerning safety and misuse, but positive trial results could unlock new markets.
• Innovation in formulations and digital health strategies will be critical for future market expansion.

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References

1. ClinicalTrials.gov. Modafinil-related trials. Link
2. Grand View Research. Modafinil Market Analysis. 2022.
3. U.S. Food and Drug Administration. Drug approvals and patent information.
4. IQVIA. Global pharmaceutical market reports, 2022-2027.
5. PubMed. Peer-reviewed publications on modafinil clinical studies.

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Disclaimer: This analysis is based on publicly available data and expert estimates as of early 2023. Market conditions and regulatory policies are subject to change. Stakeholders should conduct due diligence for specific decisions.