CLINICAL TRIALS PROFILE FOR ARMODAFINIL

All Clinical Trials for ARMODAFINIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00078312 ↗	Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder	Completed	Cephalon	Phase 3	2004-01-01	The primary objective of this study is to evaluate the safety and tolerability of Armodafinil (CEP-10953) administered on a flexible-dosage regimen of 100 to 250 mg/day for up to 12 months to patients with excessive sleepiness associated with a current diagnosis of narcolepsy, obstructive sleep apnea/hypopnea syndrome (OSAHS)(regular users of nasal continuous positive airway pressure [nCPAP] therapy), or chronic shift work sleep disorder (SWSD).
NCT00078325 ↗	Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome(OSAHS)	Completed	Cephalon	Phase 3	2004-02-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30-minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI-C) ratings (as related to general condition) at week 12, or last post-baseline visit.
NCT00078377 ↗	Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy	Completed	Cephalon	Phase 3	2004-03-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with narcolepsy by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (20-minute version)(average of 4 naps at 0900, 1100, 1300, and 1500) and by the Clinical Global Impressions of Change (CGI-C) ratings (as related to general condition) at week 12 (or last postbaseline observation)
NCT00079677 ↗	Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea (OSA/H) Syndrome	Completed	Cephalon	Phase 3	2004-03-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with residual excessive sleepiness associated with obstructive sleep apnea/hypopnea syndrome (OSAHS) by measuring mean sleep latency from the Maintenance of Wakefulness Test (MWT) (30 minute version) (average of 4 naps at 0900, 1100, 1300, and 1500) and by Clinical Global Impression of Change (CGI C) ratings (as related to general condition) at week 12 (or last postbaseline visit).
NCT00080288 ↗	Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD	Completed	Cephalon	Phase 3	2004-03-01	The primary objective of this study is to determine whether treatment with Armodafinil (CEP-10953) is more effective than placebo treatment for patients with excessive sleepiness associated with chronic shift work sleep disorder (SWSD) by measuring mean sleep latency from the Multiple Sleep Latency Test (MSLT) (20 minutes) (average of 4 naps at 0200, 0400, 0600, and 0800) and by Clinical Global Impression of Change (CGI-C) ratings.
NCT00228553 ↗	Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness	Completed	Cephalon	Phase 3	2004-05-01	A 12 Month, Open-Label, Flexible Dosage Extension Study of the Safety and Efficacy of Armodafinil (CEP-10953) in the Treatment of Patients with Excessive Sleepiness Associated with Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder
NCT00228566 ↗	Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome	Completed	Cephalon	Phase 3	2005-10-01	The purpose of this study is to assess patient reported outcomes with armodafinil treatment in terms of improvement in sleepiness, satisfaction with treatment, impact on ability to engage in life activities (ie, daily or work and family and/or social activities), and effects on fatigue. Clinician ratings on patient response to armodafinil treatment will also be assessed.

Clinical Trial Conditions for ARMODAFINIL

Condition Name

Condition Name for ARMODAFINIL
Intervention	Trials
Fatigue	10
Obstructive Sleep Apnea	6
Narcolepsy	6
Excessive Sleepiness	5

Condition MeSH

Condition MeSH for ARMODAFINIL
Intervention	Trials
Sleepiness	16
Fatigue	15
Disorders of Excessive Somnolence	12
Sleep Apnea, Obstructive	9

Clinical Trial Locations for ARMODAFINIL

Trials by Country

Trials by Country for ARMODAFINIL
Location	Trials
United States	427
Canada	7
France	5
Bulgaria	4
Australia	4

Trials by US State

Trials by US State for ARMODAFINIL
Location	Trials
New York	23
California	22
Texas	22
Pennsylvania	21
Ohio	19

Clinical Trial Progress for ARMODAFINIL

Clinical Trial Phase

Clinical Trial Phase for ARMODAFINIL
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	19
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for ARMODAFINIL
Clinical Trial Phase	Trials
Completed	44
Terminated	9
Withdrawn	3

Clinical Trial Sponsors for ARMODAFINIL

Sponsor Name

Sponsor Name for ARMODAFINIL
Sponsor	Trials
Cephalon	31
National Cancer Institute (NCI)	9
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for ARMODAFINIL
Sponsor	Trials
Other	45
Industry	43
NIH	11

Clinical Trials Update, Market Analysis, and Projection for Armodafinil

Last updated: October 28, 2025

Introduction

Armodafinil, a wakefulness-promoting agent, is the enantiomer of modafinil, commercially known as Nuvigil. Approved primarily for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with obstructive sleep apnea, armodafinil's unique pharmacological profile has garnered increasing interest beyond its traditional indications. This comprehensive review examines recent clinical trial advancements, evaluates market dynamics, and projects future growth trajectories tailored for stakeholders in the pharmaceutical landscape.

Clinical Trials Update

Recent Clinical Trials and Investigations

Over the last two years, multiple clinical trials have explored armodafinil's broader therapeutic potential. Notably, studies have aimed to assess its efficacy in cognitive enhancement, treatment of depression, and neurological disorders.

1. Cognitive Function in Post-COVID-19 Syndrome

A double-blind, placebo-controlled trial (NCT04686288) conducted in 2022 evaluated armodafinil's ability to improve cognitive deficits in post-COVID-19 patients. Preliminary results suggest significant improvements in attention and executive function, positioning armodafinil as a candidate for managing "long COVID" cognitive symptoms.

2. Depression and Mood Disorders

A Phase II trial (NCT04919824) initiated in 2021 assessed armodafinil adjunctive therapy in major depressive disorder (MDD) patients resistant to conventional treatments. Although data is pending, early reports highlight potential benefits in energy and alertness, which may translate into enhanced antidepressant effects.

3. Attention Deficit Hyperactivity Disorder (ADHD)

Several ongoing studies, such as NCT04566989, focus on armodafinil's role in ADHD management among adults. The outcomes could influence off-label prescribing practices if efficacy and safety are confirmed.

Regulatory Developments

While armodafinil has FDA approval for narcolepsy, shift work sleep disorder, and obstructive sleep apnea, regulatory agencies have yet to endorse its use for other indications. However, ongoing clinical data may catalyze label expansions or medical guideline updates, especially if emerging evidence indicates substantial benefits in neurological conditions.

Market Analysis

Current Market Landscape

The global wakefulness promoting agent market was valued at approximately USD 1.8 billion in 2022, with armodafinil constituting a significant segment, driven primarily by its branded form, Nuvigil. The drug enjoyed steady growth due to robust adoption in sleep disorder management and off-label use for cognitive augmentation.

Competitive Environment

Armodafinil faces competition from:

• Modafinil: A chemically similar compound with broader patent expiry, offering cost advantages.
• Synthetic alternatives: Emerging compounds such as adrafinil and orexin-based therapies.
• Generics: Increasing availability of generic versions post-patent expiry of original formulations.

Market Drivers & Challenges

Drivers:

• Growing prevalence of sleep disorders, notably in aging populations.
• Rising off-label utilization for neurocognitive enhancement.
• Expanding clinical evidence for new indications.

Challenges:

• Patent expirations leading to price erosion.
• Regulatory constraints limiting off-label promotion.
• Safety concerns, including potential for misuse and dependence.

Regional Market Dynamics

• North America: Dominates due to high awareness, established healthcare infrastructure, and approvals. The US accounted for approximately 60% of the global wakefulness agent sales in 2022.
• Europe: Growing adoption in sleep clinics, with regulatory expansions expected.
• Asia-Pacific: Emerging markets driven by increasing sleep disorder diagnoses and evolving healthcare systems.

Future Market Projections

The wakefulness agent market, including armodafinil, is projected to reach USD 2.7 billion by 2030, growing at a CAGR of approximately 5.2% from 2023 to 2030. Key factors include expanding approved indications, increased awareness of sleep and neurological disorders, and ongoing clinical trials exploring novel uses.

Market Opportunities & Strategic Outlook

• Expansion into Neurological and Psychiatric Disorders: Positive clinical trial outcomes could open pathways for regulatory approvals in depression, ADHD, and cognitive impairment contexts.
• Development of Generic Formulations: To compete effectively with patent expirations, generic producers can capture market share through cost-effective alternatives.
• Real-World Evidence Generation: Demonstrations of safety and efficacy in diverse populations will bolster market confidence and acceptance.
• Geographic Expansion: Targeted strategies for emerging markets with growing healthcare access present lucrative opportunities.

Conclusion & Future Outlook

Armodafinil remains a vital asset in the wakefulness pharmacotherapy segment, with promising avenues for broader indications supported by ongoing clinical research. The competitive landscape will likely intensify as patent protections lapse, encouraging generics and novel formulations. Market growth hinges on clinical validation of new uses, strategic regulatory engagement, and expansion into underpenetrated regions.

Key Takeaways

• Recent clinical trials suggest potential new indications for armodafinil, including post-COVID cognitive deficits and depression, which may influence future prescribing patterns.
• The market is mature but poised for growth driven by off-label applications, demographic trends, and emerging indications.
• Patent expirations and generic competition will pressure pricing but open opportunities for cost-effective formulations.
• Strategic engagement in clinical research and regulatory navigation is critical for market expansion.
• The global wakefulness agent market is projected to grow at a CAGR of over 5% through the decade, with armodafinil contributing significantly.

---

FAQs

Q1: What are the primary approved clinical uses of armodafinil?
A1: Armodafinil is approved for narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with obstructive sleep apnea.

Q2: Are there ongoing trials exploring armodafinil for cognitive enhancement?
A2: Yes, recent trials are investigating its efficacy in cognitive deficits related to post-COVID-19 syndrome and ADHD.

Q3: How will patent expirations impact the armodafinil market?
A3: Expiry of patents for branded formulations will likely lead to increased generic competition, reducing prices but expanding overall market access.

Q4: What challenges does armodafinil face in the future?
A4: Challenges include regulatory restrictions on off-label use, safety concerns regarding misuse, and competitive dynamics from generics and alternative therapies.

Q5: Which regions present the most significant growth opportunities?
A5: North America remains dominant, but Asia-Pacific and Europe show considerable potential due to rising sleep disorder awareness and evolving healthcare infrastructure.

---

Sources:

[1] Global Wakefulness Agents Market Report, 2022.
[2] ClinicalTrials.gov database, 2023.
[3] IQVIA Data, 2022.
[4] U.S. Food and Drug Administration (FDA) approvals, 2022.
[5] Market Research Future, 2023.