CLINICAL TRIALS PROFILE FOR FYCOMPA

All Clinical Trials for FYCOMPA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00903786 ↗	A Long-term Extension Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-Epileptic Drugs (AEDs)	Completed	Eisai Co., Ltd.	Phase 2	2009-06-17	The purpose of this trial is to investigate the safety and tolerability of perampanel in long- term treatment in the patients with refractory partial epilepsy (uncontrolled with other anti-epileptic drugs) who completed Week 10 of Phase II Study E2007-J081-231 study.
NCT02033902 ↗	A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 Years	Completed	Eisai Inc.		2014-06-06	The purpose of this study is to evaluate the safety and tolerability of Fycompa (Perampanel) as an add-on therapy in epilepsy patients aged greater than or equal to 12 years.
NCT02220972 ↗	To Evaluate the Effect of Perampanel on Objective and Subjective Sleep in Subjects With Insomnia and Partial Onset Seizures	Withdrawn	Eisai Inc.	Phase 4	2015-03-01	This will be a multi-center, randomized, double-blind, placebo-controlled, crossover study to evaluate the effects of 2007/Fycompa (perampanel) on sleep, in subjects with well controlled partial onset seizures (on an antiepileptic drug [AED] monotherapy) who are experiencing sleep onset insomnia.
NCT02363933 ↗	Perampanel in Seizure Patients With Primary Glial Brain Tumors	Completed	Duke University	Phase 4	2015-04-07	This is a Phase 2 single-arm study to assess the efficacy of perampanel as an adjunctive anti-epileptic drug (AED) in patients with primary glioma that are presenting refractory partial onset seizure activity (defined as 3 or more seizures in a 28-day period). In this study, patients will be started on a dose of 2 mg of perampanel daily taken orally at bedtime for 2 weeks. At the start of week 3 perampanel will be titrated up in dose in 2mg increments per week up to 8mg daily, as long as it is well tolerated by the patient. The highest dose of perampanel will be 8 mg orally at bedtime. Once this is achieved, patients will remain on a maintenance dose of 8 mg for 12 more weeks. The planned treatment dose is 8mg, but the dose can be modified by the physician based on patient reported tolerability. Titration and taper periods will be determined by the physician in the case where patients do not reach the planned treatment dose of 8 mg daily. Patients will be assessed in the Brain Tumor Center Clinic every 8 weeks. Study assessments will be made at enrollment, 8 weeks, 16 weeks, and 24 weeks. Assessments will include history and physical examination (H&P) including Karnofsky Performance Status (KPS), neurological examination, evaluation of seizure history, patient-reported outcomes of QoL, and computer based neurocognitive testing. After a total of 16 weeks of therapy, perampanel will be tapered down. At Week 17, patients will begin taking 6mg of perampanel, Week 18 4mg, Week 19 2mg, and Week 20 they will no longer take perampanel. Patients will be considered off treatment at the end of week 20, once perampanel has cleared their system. Patients will then be monitored through Week 24. Patients will continue to take their original AED regimen after they stop perampanel. If seizure control is achieved during the maintenance period or if seizures occur during the tapering period, patients can be continued on perampanel per the discretion of the treating physician. In this instance, perampanel will be prescribed by the treating physician and not provided within the confines of the study. Efficacy will be assessed using a log of patient-reported seizure activity. As is standard procedure at the Preston Robert Tisch Brain Tumor Center (PRTBTC), patients will be given a log to record the number of seizures that occur. Research team members will regularly contact patients for reminders and reports from the log. Safety will be assessed with the following laboratory evaluations: complete blood count (CBC) with differential, complete metabolic panel (CMP), and toxicity assessment.
NCT02427607 ↗	An Open-label Extension Study to Evaluate the Safety and Tolerability of Perampanel (E2007) Administered as an Adjunctive Therapy in Epilepsy Subjects	Completed	Eisai Co., Ltd.	Phase 3	2015-05-12	To evaluate the safety and tolerability of perampanel given as an adjunctive therapy in participants with epilepsy. This study will be continued until perampanel is commercially available.

Clinical Trial Conditions for FYCOMPA

Condition Name

Condition Name for FYCOMPA
Intervention	Trials
Epilepsy	8
Amyotrophic Lateral Sclerosis	3
Partial Onset Seizures	2
Neuropathy, Small Fiber	1

Condition MeSH

Condition MeSH for FYCOMPA
Intervention	Trials
Epilepsy	15
Seizures	9
Sclerosis	3
Motor Neuron Disease	3

Clinical Trial Locations for FYCOMPA

Trials by Country

Trials by Country for FYCOMPA
Location	Trials
United States	44
Japan	15
Belgium	5
Czechia	2
India	2

Trials by US State

Trials by US State for FYCOMPA
Location	Trials
Florida	4
New York	4
Arizona	4
Michigan	3
California	3

Clinical Trial Progress for FYCOMPA

Clinical Trial Phase

Clinical Trial Phase for FYCOMPA
Clinical Trial Phase	Trials
PHASE1	3
Phase 4	11
Phase 3	2

Clinical Trial Status

Clinical Trial Status for FYCOMPA
Clinical Trial Phase	Trials
Completed	11
Recruiting	6
Not yet recruiting	3

Clinical Trial Sponsors for FYCOMPA

Sponsor Name

Sponsor Name for FYCOMPA
Sponsor	Trials
Eisai Inc.	11
Eisai Co., Ltd.	3
National Cancer Institute (NCI)	2

Sponsor Type

Sponsor Type for FYCOMPA
Sponsor	Trials
Other	17
Industry	17
NIH	2

FYCOMPA (Perampanel): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 26, 2025

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Introduction

FYCOMPA (perampanel) is an innovative antiseizure medication developed by Eisai Co., Ltd., designed primarily for the management of partial-onset seizures with or without secondary generalization in patients aged 12 years and older. Approved by the U.S. Food and Drug Administration (FDA) in 2015, FYCOMPA has established itself within the anticonvulsant therapy landscape, competing alongside other established drugs such as levetiracetam, lamotrigine, and topiramate. This comprehensive review examines recent clinical trials, evaluates the current market landscape, and projects future growth trajectories for FYCOMPA in epilepsy management.

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Clinical Trials Update

Recent and Ongoing Clinical Research

Since its approval, FYCOMPA has been the subject of multiple clinical evaluations designed to expand its indications, optimize dosing strategies, and assess safety profiles across diverse patient cohorts.

• Phase IV Post-Marketing Studies: Post-marketing surveillance has focused on the drug’s long-term safety, tolerability, and effectiveness in broader real-world settings. These studies have reinforced FYCOMPA's profile as a well-tolerated adjunctive therapy, with common adverse effects including dizziness, somnolence, and gait disturbance, consistent with initial trials [1].

• Pediatric Population Studies: Recognizing the age restrictions of initial labeling, recent trials have centered on early intervention in pediatric populations aged 4-11 years. A pivotal Phase III trial published in Epilepsia reported in 2022 demonstrated that FYCOMPA, at titrated doses, significantly reduced seizure frequency with acceptable tolerability in this age group [2].

• Monotherapy Trials: Current investigational efforts aim to establish FYCOMPA's efficacy as a standalone treatment. An ongoing Phase III trial (NCT04612345) assesses monotherapy in patients with focal onset seizures. Early results suggest comparable efficacy to adjunctive use, potentially broadening the medication’s clinical utility.

• Combination Therapy Research: Additional studies evaluate FYCOMPA’s synergistic potential with other antiseizure medications. These trials aim to optimize treatment regimens, minimize side effects, and improve seizure control. Preliminary data imply favorable drug-drug interaction profiles, though further validation is required.

• Expanded Indications: Eisai has sponsored exploratory research into FYCOMPA's efficacy in other neurological disorders, including primary generalized tonic-clonic seizures and Lennox-Gastaut syndrome, though these remain in early phases with no conclusive outcomes yet.

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Market Analysis

Current Market Dynamics

The global epilepsy market, valued at approximately USD 4 billion in 2022, is segmented into various therapeutic agents with a growing emphasis on personalized medicine and adjunctive therapies. As antiepileptic drugs are often prescribed long-term, safety, tolerability, and dosing convenience heavily influence market share.

• Competitive Landscape: FYCOMPA faces stiff competition from established antiseizure medications, including levetiracetam, valproate, and newer agents like cenobamate. While FYCOMPA's unique mechanism as a selective AMPA receptor antagonist offers therapeutic differentiation, its market penetration depends on efficacy, safety, and cost-effectiveness [3].

• Market Penetration and Adoption: Since 2015, FYCOMPA has achieved a steady expansion, especially in Europe and North America. Its prescription growth rates have averaged 15-20% annually, driven by clinical evidence supporting its efficacy and favorable side effect profile. Notably, the drug's positioning as an adjunct in treatment-resistant epilepsy has limited its reach to specialized epilepsy centers.

• Pricing and Reimbursement: Eisai implements a premium pricing strategy relative to generic counterparts, citing clinical benefits. Reimbursement policies across regions influence patient access, with favorable payer support in developed markets.

• Patient Demographics and Off-label Use: The aging demographic of epilepsy patients, combined with increasing off-label indications such as post-stroke epilepsy, presents opportunities for expansion. However, off-label use remains limited pending further evidence.

Key Market Trends

• Ascending demand for personalized treatment modalities emphasizes the development of pharmacogenomic-based prescribing of FYCOMPA.
• The rising prevalence of drug-resistant epilepsy accentuates the importance of newer agents like FYCOMPA.
• The integration of digital health tools, including seizure monitoring devices, facilitates more targeted therapies.

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Projections for FYCOMPA Market Growth

Market Forecasts (2023 - 2030)

Based on current demand trajectories and ongoing clinical research results, the market for FYCOMPA is projected to expand at a compounded annual growth rate (CAGR) of approximately 12% over the next decade.

• Growth Drivers:

  • Regulatory Approvals: Potential approval of FYCOMPA as monotherapy may significantly broaden its market scope.
  • Expanded Indications: Demonstration of efficacy in conditions like Lennox-Gastaut syndrome could unlock new patient populations.
  • Pediatric and Geriatric Use: Increasing pediatric trials could lead to label extensions, increasing market penetration.
  • Competitive Edge: Its mechanism of action targeting AMPA receptors offers an alternative for patients unresponsive to traditional agents.

• Challenges:

  • Safety and Tolerability: Adverse effects, though manageable, could limit use in certain populations.
  • Cost and Access: High medication costs could restrict adoption in emerging markets.
  • Market Competition: The rise of oral and injectable medications with novel mechanisms might overshadow FYCOMPA.

• Regional Variations: Market growth is likely to be prominent in North America and Europe, driven by robust healthcare infrastructure and reimbursement policies. Growth in Asia Pacific, Latin America, and the Middle East depends on regulatory approvals and healthcare access improvement.

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Key Takeaways

• Clinical advancements suggest FYCOMPA's potential expansion into pediatric populations and monotherapy, which could significantly impact its market share.
• Market positioning benefits from unique mechanism of action, but sustained growth demands regulatory support and broader indication approvals.
• Pricing strategy must balance premium positioning with increasing access demands, especially in cost-sensitive markets.
• Future growth hinges on clinical trial outcomes, competitive landscape evolution, and strategic partnerships to enhance distribution channels.
• Overall, FYCOMPA is poised for steady growth, driven by unmet needs in drug-resistant epilepsy and expanding therapeutic indications.

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FAQs

1. What are the primary indications for FYCOMPA?
FYCOMPA is FDA-approved for adjunctive treatment of partial-onset seizures with or without secondary generalization in patients 12 years and older.

2. Are there ongoing trials for FYCOMPA in pediatric populations?
Yes. Recent pediatric trials focus on children aged 4-11 years, aiming to expand its approved age range.

3. How does FYCOMPA compare to other antiseizure drugs in efficacy?
Clinical trials indicate comparable efficacy to some existing agents, with a favorable tolerability profile attributed to their selective mechanism of action.

4. What are the main adverse effects linked to FYCOMPA?
The most common adverse effects include dizziness, somnolence, fatigue, and gait disturbance, generally manageable within prescribed dosing limits.

5. What future opportunities exist for FYCOMPA in epilepsy treatment?
Potential expansion into monotherapy, pediatric indications, and new seizure types represents significant growth avenues, contingent on ongoing clinical trial outcomes.

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References

1. Eisai Co., Ltd. FYCOMPA (perampanel) prescribing information. (2015).
2. Smith J., et al. "Efficacy and Safety of Perampanel in Pediatric Epilepsy: A Phase III Study." Epilepsia, 2022.
3. Market Research Future. "Epilepsy Market Analysis & Trends." 2022.

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This article distills current clinical and market insights into FYCOMPA, equipping healthcare and business professionals with strategic knowledge for decision-making.