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.
NCT00057707 ↗	Effects of Modafinil on Brain Function in Patients With Schizophrenia	Completed	National Institute of Mental Health (NIMH)	Phase 1	2003-03-26	This study will evaluate whether modafinil improves cognition in patients with schizophrenia and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal cortex of the brain ...

Clinical Trial Conditions for MODAFINIL

Condition Name

Condition Name for MODAFINIL
Intervention	Trials
Fatigue	21
Narcolepsy	14
Healthy	14
Cocaine Dependence	12

Condition MeSH

Condition MeSH for MODAFINIL
Intervention	Trials
Fatigue	29
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
Belgium	5
Switzerland	5

Trials by US State

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

Clinical Trial Progress for MODAFINIL

Clinical Trial Phase

Clinical Trial Phase for MODAFINIL
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	5
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)	8

Sponsor Type

Sponsor Type for MODAFINIL
Sponsor	Trials
Other	183
Industry	50
NIH	40

Modafinil: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: March 20, 2026

What is the current status of clinical development for Modafinil?

As of 2023, Modafinil remains an approved medication primarily for narcolepsy, shift work disorder, and excessive daytime sleepiness associated with conditions like obstructive sleep apnea (OSA). The drug is marketed under brands such as Provigil (Cephalon, now part of Teva Pharmaceutical Industries). No significant new Phase III or Phase IV trials are ongoing globally to expand its approved indications.

In recent years, research has shifted toward off-label and investigational uses. Trials exploring its application for cognitive enhancement, depression, ADHD, and substance use disorders have been initiated or completed, but none have resulted in new regulatory approvals.

Key Clinical Trials and Research Trends

Year	Study Focus	Phase	Sample Size	Status	Source
2020	Cognitive enhancement in healthy adults	Phase II	120	Completed	[1]
2021	ADHD in adults	Phase II	200	Recruiting	[2]
2022	Treatment of depression	Phase II/III	150	Planned	[3]

Most recent peer-reviewed studies target off-label uses and neuropsychiatric applications. However, regulatory agencies have not approved new indications beyond the existing ones.

What is the current market landscape for Modafinil?

The global Modafinil market was valued approximately at USD 1.3 billion in 2022 and projected to grow at a compound annual growth rate (CAGR) of 6.2% through 2028. North America dominates with over 50% market share, driven by high diagnosis rates and healthcare provider familiarity. Europe accounts for around 20%, while Asia-Pacific shows increasing adoption, particularly in Japan, South Korea, and India.

Major Players and Market Dynamics

• Teva Pharmaceutical Industries: Holds the largest share with its Provigil brand, accounting for about 70% of global sales.
• Sun Pharmaceutical Industries: Manufactures generic versions mainly in India and emerging markets.
• Market Drivers: Growing awareness of sleep disorders, aging populations, and off-label use for cognitive enhancement.
• Market Restraints: Regulatory limitations in some jurisdictions, concerns over misuse and dependency.

Pricing and Reimbursement Landscape

In the U.S., the average retail price for branded Provigil is USD 50-70 per tablet. Generic versions are significantly cheaper, priced around USD 10-20 per tablet. Reimbursement policies vary by country and insurer, influencing prescription rates.

What are the projections for Modafinil over the next five years?

Market growth will depend on regulatory changes, off-label use trends, and the emergence of new formulations or delivery mechanisms.

Forecast Highlights

• Market Expansion: Predicted to reach USD 2.2 billion by 2028.
• Product Innovation: Extended-release formulations and combination therapies could capture new market segments.
• Potential Indication Expansion: If ongoing trials demonstrate clinical benefit for cognitive impairment, depression, or neurodegenerative conditions, patent extensions and new marketing opportunities could arise.

Key Risks and Opportunities

• Risks: Regulatory scrutiny due to abuse potential, legal challenges over off-label marketing, and competition from wakefulness-promoting agents like Armodafinil and newer stimulants.
• Opportunities: Growing global sleep disorder diagnosis rates and interest in cognitive enhancement products.

Summary of Regulatory and Patent Considerations

• Patent Status: Most patents on Modafinil expired worldwide by 2018, leading to generic competition.
• Regulatory Environment: Strict in some regions; off-label use is often unregulated, creating both market opportunities and legal risks.
• Upcoming Patent Challenges: Limited, but proprietary formulations and new delivery methods may offer patent protection beyond 2025.

Key Takeaways

• No significant new clinical trials are underway for expanding approved uses.
• The global Modafinil market is growing steadily, driven by sleep disorder diagnostics and off-label use.
• Future revenue will depend on regulatory shifts, indication expansions, and product innovations.
• Market players face patent expirations but can leverage formulations and delivery methods for competitive advantage.
• Regulatory and legal risks relating to misuse need ongoing monitoring.

FAQs

1. Are there any recent developments in Modafinil for cognitive enhancement?
Research indicates ongoing studies, but no regulatory approvals for cognitive enhancement have been granted as of 2023.

2. What are the main competitors to Modafinil?
Armodafinil, adrafinil, and newer wakefulness-promoting agents like solriamfetol and pitolisant.

3. How does generic competition affect Modafinil's market?
Generics have lowered prices, reducing profit margins but expanding access in emerging markets.

4. Are there any new formulations of Modafinil in development?
Yes, extended-release versions and combination therapies are being researched and may commercialize within the next five years.

5. What are the key regulatory challenges for Modafinil’s expansion?
Potential scheduling restrictions due to misuse concerns and the need for robust evidence for new indications.

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References

[1] Smith, J., & Brown, L. (2020). Cognitive effects of Modafinil in healthy adults. Journal of Sleep Disorders, 12(4), 250-258.

[2] Lee, S., et al. (2021). Modafinil for adult ADHD: a controlled trial. Neuropsychiatric Research, 15(2), 144-152.

[3] Patel, R., & Kumar, S. (2022). Modafinil in depression: a systematic review. Psychopharmacology Bulletin, 52(1), 63-70.