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).

Clinical Trial Conditions for armodafinil

Condition Name

Condition Name for armodafinil
Intervention	Trials
Fatigue	10
Narcolepsy	6
Obstructive Sleep Apnea	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
Australia	4
Ukraine	4

Trials by US State

Trials by US State for armodafinil
Location	Trials
New York	23
Texas	22
California	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

Armodafinil: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What are the latest updates in clinical trials for Armodafinil?

Armodafinil, marketed primarily as Nuvigil by Cephalon (a Teva Pharmaceutical subsidiary), has undergone multiple phase trials focusing on narcolepsy, shift work sleep disorder, and excessive daytime sleepiness associated with Parkinson’s disease and ADHD. The FDA approved it in 2007 for narcolepsy, with subsequent expansions into treatments of sleep disorders.

Recent clinical trials include:

• Phase 4 (Post-Marketing Surveillance): Ongoing evaluations assessing long-term safety in diverse populations. These studies focus on cognitive enhancement in ADHD and residual sleepiness in Parkinson's patients.

• New indications: Trials assess efficacy for conditions like obstructive sleep apnea and fatigue in multiple sclerosis. For example, a 2021 trial (NCT04531997) evaluated Armodafinil in multiple sclerosis fatigue with preliminary positive results.

• Drug interactions: Several trials investigate interactions with other CNS-active drugs, such as modafinil and amphetamines, to understand safety and efficacy dynamics.

Overall, clinical development has shifted from new drugs to confirming long-term safety, exploring off-label uses, and assessing specific patient populations.

How does Armodafinil compare to Modafinil in clinical outcomes?

Armodafinil is the R-enantiomer of Modafinil, proposed to have a longer half-life (approximately 15 hours vs. 12 hours for modafinil) and potentially improved tolerability:

Parameter	Armodafinil	Modafinil
Half-life	~15 hours	~12 hours
Bioavailability	80-85%	60-65%
Onset of action	30-60 minutes	30-60 minutes
Approved indications	Narcolepsy, shift work disorder	Narcolepsy, shift work disorder, obstructive sleep apnea

Meta-analyses suggest similar efficacy but some evidence points to slightly improved wakefulness maintenance with Armodafinil due to its longer duration.

What are recent market trends and projections?

Market size and growth

• Global market value (2022): Estimated at $1.4 billion, with a compound annual growth rate (CAGR) of 7.2% projected through 2030 ([1]).

• Key drivers: Increasing prevalence of sleep disorders, expanding off-label use in cognitive enhancement, and rising awareness of the safety profile over older stimulants.

• Regulatory landscape: Armodafinil is approved in over 80 countries; regulatory efforts aim to manage off-label prescribing and mitigate abuse potential.

Competitive landscape

Major Players	Market Share (2022)	Notable Products
Teva Pharmaceuticals	75%	Nuvigil, generic formulations
Cephalon (subsidiary of Teva)	15%	Licensing agreements
Others	10%	Off-label generic competitors

Off-label uses and unapproved markets

R&D activities explore cognitive enhancement in healthy individuals. The off-label use, combined with limited abuse potential compared to traditional stimulants, presents a niche growth avenue.

Regulatory and patent considerations

Teva’s patent for Nuvigil expired in the US in 2019, prompting generic competition. Patent protections in other markets remain active until 2024-2026. Regulatory agencies have increased scrutiny over off-label marketing practices.

What are projections for future market performance?

• Market growth: Expected to reach $2.3 billion by 2030, driven by increased prescription volume and off-label use.

• Pipeline developments: Ongoing trials aim to expand indications, which could add 10-15% growth annually if approved.

• Challenges: Regulatory limitations, potential abuse concerns, competition from newer wake-promoting agents like solriamfetol.

• Opportunities: Custom formulations for specific populations, combination therapies, and personalized medicine approaches.

Summary table: Key factors influencing growth

Factor	Impact
Increasing sleep disorder prevalence	Drives primary demand
Patent expiry and generics	Lowers cost, widens accessibility
Off-label cognitive use	Expands market beyond sleep disorders
Regulatory developments	May restrict or expand prescribing practices
New clinical indications	Could introduce additional revenue streams

Key Takeaways

• Clinical trials are focused on long-term safety, off-label uses, and new indications such as multiple sclerosis fatigue.
• Armodafinil's longer half-life and improved pharmacokinetic profile may offer advantages over modafinil.
• The market has experienced steady growth, with projections reaching over $2.3 billion by 2030, despite patent expiries.
• Competition from generics and regulatory oversight pose challenges, but off-label applications and pipeline advances offer growth potential.
• R&D efforts may unlock new indications, further expanding Armodafinil’s market reach.

FAQs

1. What are the main approved medical uses of Armodafinil?
Narcolepsy, shift work sleep disorder, and excessive sleepiness associated with obstructive sleep apnea.

2. Are there ongoing trials for off-label uses?
Yes. Trials are underway for cognitive enhancement and fatigue in multiple sclerosis and Parkinson’s disease.

3. How does Armodafinil differ pharmacologically from Modafinil?
It is the R-enantiomer of Modafinil, with a longer half-life and potentially a smoother wakefulness profile.

4. What is the impact of patent expiries on Armodafinil's market?
Patent expiries have led to increased generic availability, reducing costs and expanding access.

5. Which regions are leading in Armodafinil adoption?
North America and Europe hold significant shares due to early approvals and established prescriber bases.

References

[1] Grand View Research. (2022). Wakefulness-promoting agents market size, share & trends analysis.