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
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
Ukraine	4
Bulgaria	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 Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is armodafinil’s current clinical development footprint?

Armodafinil is an FDA-approved wake-promoting agent indicated for excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), and shift work sleep disorder (SWSD). Most post-approval activity in this class concentrates on label-expansion, formulation changes, and real-world effectiveness rather than new mechanism entrants.

Clinical trials update (high-level):

• Core approvals: Armodafinil is already marketed; ongoing trial activity typically supports incremental claims (e.g., comparator studies, adherence endpoints, special populations) rather than replacing the existing approved clinical package.
• Competition-driven studies: Trials tend to measure wakefulness endpoints and functional outcomes against other wake-promoting agents (modafinil, solriamfetol, pitolisant) and updated standards of care.

Practical takeaway for R&D and investment

• The near-term value of additional armodafinil trials is mainly tied to market access and differentiation: payer outcomes, long-term tolerability, and dosing/adherence advantages relative to competing wake-promoters.
• New efficacy submissions are less likely to be decisive than formulation and evidence-generation in managed care environments.

How does the armodafinil market stack up versus wake-promoter competitors?

Armodafinil operates in the wake-promoter segment shaped by three dynamics: (1) day-time sleepiness demand is stable, (2) payer scrutiny is rising as alternatives add mechanistic diversity, and (3) differentiation shifts from efficacy alone to tolerability, dosing convenience, and formulary position.

Key competitor landscape

• Modafinil (generic): Price pressure is persistent.
• Solriamfetol: Has a growing position in hypersomnolence markets due to efficacy and flexible dosing profiles.
• Pitolisant: Adds an alternative mechanism with payer-specific adoption patterns.

Where armodafinil fits

• Armodafinil is positioned as a well-established branded wake-promoter with a mature safety and efficacy dossier and a clear label across narcolepsy, OSA, and SWSD.
• The commercial challenge is not clinical feasibility; it is retaining formulary placement against mechanistically distinct entrants and cheaper generics.

What is the market outlook for armodafinil through the projection period?

A reliable projection depends on uptake in indications and pricing dynamics versus generics and newer entrants. For armodafinil, the dominant variables are:

• Generic penetration in the broader wake-promoter class
• Formulary channel preferences (step therapy and PA policies in sleep disorder pathways)
• Gross-to-net erosion from rebates, switching, and channel strategy

Projection framework (directional, decision-oriented)

• Base case: Moderate volume stability with ongoing pricing pressure, partially offset by brand resilience where plan preferences favor armodafinil.
• Downside: Faster switching to solriamfetol or pitolisant in preferred formularies and more aggressive step therapy where generics set the reference price.
• Upside: Sustained niche strength in payer systems that favor armodafinil for specific adherence and tolerability outcomes, plus continued adoption for SWSD and OSA workflows.

How do indication-level dynamics affect pricing and volume?

Armodafinil’s three labeled indications do not behave identically in payer management.

Narcolepsy

• Typically drives steady maintenance prescriptions because symptoms are chronic and adherence matters.
• Payers often enforce prior authorization but also face clinician pressure for stable wakefulness control.

OSA (excessive sleepiness)

• Access depends on the adequacy of CPAP and documentation of residual sleepiness.
• Commercialization is sensitive to sleep medicine practice patterns and claims documentation requirements.

SWSD

• More sensitive to adherence and dosing scheduling, which can amplify switching risk when alternatives are perceived to fit work cycles better.

What is the likely revenue trajectory under typical formulary conditions?

Armodafinil revenue typically follows a pattern common to mature branded CNS therapies:

• Initial brand strength persists where prescribers and plans keep continuity.
• Over time, gross-to-net compresses as generic comparators expand and newer wake-promoters take preferred positions in some formularies.

Most likely market trajectory for armodafinil

• Volume: Gradual erosion over the long run, but not a collapse if brand remains in formularies for at least one step.
• Price: Sustained downward pressure via generic reference pricing and competitive contracting.
• Net revenue: Stabilizes unless formulary exclusion accelerates due to cost-effectiveness pressures.

What are the key decision points for R&D and commercial strategy?

For armodafinil, the most actionable R&D priorities are not new mechanism breakthroughs but evidence that strengthens payer acceptance and clinician confidence.

High-impact development directions (commercially aligned)

• Real-world evidence (adherence, work-function outcomes, discontinuation rates)
• Comparative effectiveness vs leading alternatives in payer-relevant endpoints
• Safety monitoring data focused on long-term tolerability in routine practice

Commercial priorities

• Tight documentation support for PA criteria in OSA
• Contracting strategies that reduce switching barriers in narcolepsy
• Patient support and dosing adherence tools targeted to SWSD routines

Key Takeaways

• Armodafinil’s market is anchored by established labeled indications and mature clinical evidence.
• Competitive pressure in wake-promoter therapy is defined less by absolute efficacy and more by formulary positioning, pricing, and managed care pathways.
• Near-term clinical trial value is most likely tied to payer-relevant outcomes, real-world effectiveness, and comparative evidence rather than major label reinvention.
• Revenue trajectory is expected to reflect mature-branded dynamics: stable-to-declining pricing with slower volume erosion, contingent on formulary access and switching intensity.

FAQs

1. Is armodafinil still actively studied in clinical trials?
   Yes, but post-approval activity in this class primarily supports incremental evidence generation (real-world outcomes, comparative endpoints, and formulations) rather than replacing core efficacy findings.

2. Which indications drive the most durable use for armodafinil?
   Narcolepsy tends to show more durability because it is chronic and maintenance-focused; OSA depends on CPAP adequacy documentation; SWSD is more sensitive to adherence and work-cycle scheduling.

3. How do newer wake-promoter competitors change the armodafinil outlook?
   Solriamfetol and pitolisant increase payer options and can displace armodafinil where cost-effectiveness contracts favor newer agents, especially under step therapy.

4. What type of trials would matter most commercially for armodafinil?
   Trials and studies that generate payer-relevant endpoints: adherence, functional outcomes, and comparative effectiveness in real-world settings.

5. What is the main risk to armodafinil’s long-run market position?
   Faster switching and formulary exclusion driven by generic price benchmarks and competitive contracting from newer wake-promoters.

References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Armodafinil (Nuvigil) prescribing information. FDA. https://www.accessdata.fda.gov/