CLINICAL TRIALS PROFILE FOR CENOBAMATE

All Clinical Trials for cenobamate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01397968 ↗	Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures	Unknown status	SK Life Science	Phase 2	2011-05-01	This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.
NCT01397968 ↗	Efficacy and Safety of YKP3089 in Subjects With Treatment Resistant Partial Onset Seizures	Unknown status	SK Life Science, Inc.	Phase 2	2011-05-01	This study is to evaluate the efficacy of YKP3089 in reducing seizure frequency when compared to baseline in subjects with partial onset seizures not fully controlled despite their treatment with 1 to 3 concomitant anti-epileptic drugs. Also to evaluate the safety and tolerability of YKP3089.
NCT03234699 ↗	Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs as a Means of Predicting Drug-drug Interactions	Completed	SK Life Science	Phase 1	2017-02-22	This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5, CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo probes. In order to avoid a potential pharmacokinetic interaction between the probes, midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time period between the 2 assessments. The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2 weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day of cenobamate for all CYP probes. The results of this DDI study will provide a basis to make appropriate dose recommendation for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic pathway.
NCT03234699 ↗	Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs as a Means of Predicting Drug-drug Interactions	Completed	SK Life Science, Inc.	Phase 1	2017-02-22	This study is aimed to investigate the influence of cenobamate on the activity of CYP3A4/5, CYP2B6, CYP2C19, and CYP2C9 by using drugs recommended by both the FDA and EMA as in vivo probes. In order to avoid a potential pharmacokinetic interaction between the probes, midazolam (CYP3A), warfarin (CYP2C9), and omeprazole (CYP2C19) will be administered together as a validated cocktail and separately from bupropion (CYP2B6) using an adequate washout time period between the 2 assessments. The starting daily dose of cenobamate will be 12.5 mg, which will be administered for 2 weeks. Then, daily cenobamate doses will be increased every 2 weeks to 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. The CYP probes will be tested before cenobamate administration, at steady state at 100mg/day of cenobamate for midazolam only and finally at steady state at 200mg/day of cenobamate for all CYP probes. The results of this DDI study will provide a basis to make appropriate dose recommendation for a safe use of concomitant drugs with cenobamate using these isoenzymes in their metabolic pathway.
NCT03509285 ↗	A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users	Completed	SK Life Science	Phase 1	2017-03-08	This randomized, single-dose, placebo- and active-controlled, crossover study will evaluate the abuse liability potential of cenobamate in recreational drug users with sedative drug use experience. In the Qualification phase, subjects will receive a single dose of either alprazolam or placebo in a crossover design, with a wash-out period of at least 24 hours between treatments. Subjects who are clearly able to distinguish the positive control from placebo will be enrolled in the Treatment phase and will be randomized to single oral doses of cenobamate (2 dose levels), alprazolam (2 dose levels), and placebo in a double-blind, double-dummy, 5-way crossover design. Washout-periods between the 5 treatment periods in the Treatment phase will be at least 16 days.

Clinical Trial Conditions for cenobamate

Condition Name

Condition Name for cenobamate
Intervention	Trials
Partial Epilepsy	3
Healthy	2
Epilepsies, Partial	1
Partial Seizure	1

Condition MeSH

Condition MeSH for cenobamate
Intervention	Trials
Seizures	7
Epilepsy	4
Epilepsies, Partial	4
Epilepsy, Generalized	3

Clinical Trial Locations for cenobamate

Trials by Country

Trials by Country for cenobamate
Location	Trials
United States	68
Poland	14
Ukraine	10
India	5
Bulgaria	3

Trials by US State

Trials by US State for cenobamate
Location	Trials
Maryland	6
Pennsylvania	4
Florida	4
California	4
Minnesota	3

Clinical Trial Progress for cenobamate

Clinical Trial Phase

Clinical Trial Phase for cenobamate
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	1
PHASE2	1

Clinical Trial Status

Clinical Trial Status for cenobamate
Clinical Trial Phase	Trials
Recruiting	7
Completed	3
Active, not recruiting	1

Clinical Trial Sponsors for cenobamate

Sponsor Name

Sponsor Name for cenobamate
Sponsor	Trials
SK Life Science, Inc.	12
SK Life Science	3
Ono Pharmaceutical Co. Ltd	2

Sponsor Type

Sponsor Type for cenobamate
Sponsor	Trials
Industry	17
OTHER	1

Clinical Trials Update, Market Analysis, and Projection for Cenobamate

Last updated: October 28, 2025

Introduction

Cenobamate (trade name: Xcopri, developed by SK Biopharmaceuticals and marketed by UCB) is an antiepileptic drug (AED) approved by the U.S. Food and Drug Administration (FDA) in 2019 for the treatment of partial-onset seizures in adults. Its emergence as a potential novel therapy in epilepsy has driven significant clinical research, with promising efficacy and safety profiles. This analysis provides a comprehensive update on the latest clinical trials, evaluates current market dynamics, and projects future growth trajectories for Cenobamate within the epilepsy therapeutic landscape.

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Clinical Trials Update

Recent Clinical Trials and Key Outcomes

Since its FDA approval, Cenobamate has been subjected to multiple ongoing and completed clinical investigations aimed at expanding its indications and understanding its long-term safety.

• Phase IV/Post-Marketing Surveillance: Post-approval, SK Biopharmaceuticals and UCB have conducted real-world safety and effectiveness studies. Data from these studies underscore Cenobamate’s role as a potent adjunctive therapy with a favorable side effect profile when titrated carefully. Reports indicate sustained seizure reduction and improved quality of life metrics.[1]

• New Indication Trials:

  • Generalized Epilepsy: While initially approved for focal seizures, Phase II trials exploring Cenobamate's efficacy in generalized seizures are underway, with preliminary data suggesting potential benefits.
  • Dravet Syndrome and Lennox-Gastaut Syndrome: Trials are examining if Cenobamate can benefit severe epileptic syndromes characterized by multifocal or generalized seizures.

• Long-term Safety Trials:

  • A pivotal open-label extension study involving over 1000 patients demonstrated a consistent seizure reduction over a 2-year period, with manageable adverse events primarily including dizziness, somnolence, and fatigue.[2]

• Drug-Drug Interaction Studies:

  • Recent pharmacokinetic investigations highlight Cenobamate’s enzyme-modulating effects, particularly on CYP2B6 and CYP3A4, necessitating dose adjustments when co-administered with other ASDs or medications metabolized via these pathways.[3]

Emerging Data and Clinical Insights

The evolving evidence base suggests Cenobamate’s efficacy surpasses many existing AEDs, particularly in drug-resistant populations. Its mechanism, involving modulation of voltage-gated sodium channels and GABA_A receptors, offers a dual approach to seizure control, distinguishing it from traditional monotherapies.

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Market Analysis

Current Market Landscape

• Market Penetration:

  • Since its approval, Cenobamate has gained rapid adoption in the U.S. within specialized epilepsy centers. As of 2022, analysts estimate that approximately 10-15% of adult epilepsy patients in the U.S. are prescribed Cenobamate, reflecting strong prescriber confidence.[4]
  • The drug's adoption is supported by its dosing simplicity and substantial seizure reduction efficacy.

• Competitive Positioning:

  • Cenobamate enters a saturated AED market dominated by drugs like levetiracetam, lamotrigine, and carbamazepine. However, its unique mechanism and efficacy profile position it favorably among newer agents like lacosamide and ezogabine.
  • Its primary competitors are drugs indicated for similar refractory epilepsies, with cenobamate’s higher responder rates providing a competitive edge.

• Pricing and Reimbursement:

  • The average wholesale price (AWP) for Cenobamate ranges between $18 to $24 per tablet, translating to approximately $540 to $720 monthly for a standard dose.[5]
  • Insurance coverage and prior authorization requirements influence patient access, though formulary inclusion is improving.

Market Drivers and Constraints

• Drivers:

  • Growing prevalence of epilepsy (~3.4 million Americans, per CDC) and treatment-resistant epilepsy cases.
  • Increasing physician awareness and favorable clinical data.
  • Expansion into Europe and Asia, where regulatory decisions are pending or underway.

• Constraints:

  • Safety concerns related to drug interactions and adverse events, especially in polypharmacy scenarios.
  • Limited data on use in pediatric populations and specific epileptic syndromes.
  • High competition from existing therapies and generics.

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Market Projection

Global Market Forecast (2023-2030)

• Market Size and Growth Rate:

  • The global epilepsy drug market was valued at approximately $2.7 billion in 2022, projected to grow at a compound annual growth rate (CAGR) of 6-8% over the next decade.[6]
  • Cenobamate, gaining share as a high-efficacy agent, is expected to capture 15-20% of the refractory epilepsy segment by 2030, translating into a revenue estimate of $500 million to $1 billion globally.

• Key Factors Influencing Growth:

  • Clinical Expansion: Pending trials in generalized and pediatric epilepsies could broaden its target patient population.
  • Geographic Expansion: Regulatory approvals in Europe, Japan, and emerging markets will open new revenue streams.
  • Pipeline synergies: Potential combination therapies with other AEDs that may enhance efficacy.

Long-term Outlook

Given the current clinical validation and market dynamics, Cenobamate is poised for sustained growth, potentially consolidating its position as a preferred option for refractory partial-onset epilepsy. Its success will largely depend on further clinical evidence, safety management, and strategic marketing.

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Key Takeaways

• Efficacy & Safety: Clinical trials affirm Cenobamate’s superior seizure reduction capability, especially in drug-resistant populations, with manageable side effects predominantly during titration phases.

• Market Penetration: Post-approval, Cenobamate is gaining rapid adoption in the U.S., with expanding prescriber confidence. Its unique dual mechanism offers competitive differentiation but faces market saturation.

• Regulatory & Geographic Expansion: Pending approvals in Europe and Asia are crucial for global market growth, with additional indications potentially expanding its use.

• Market Projections: The drug industry expects Cenobamate to reach $500 million to $1 billion in annual revenues globally by 2030, driven by increased prevalence, expanding indications, and market penetration.

• Challenges & Opportunities: Managing drug-drug interactions and safety will remain key. Conversely, unmet needs in view of highly refractory epilepsies underpin significant growth potential.

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FAQs

1. What distinguishes Cenobamate from other AEDs?
Cenobamate’s dual mechanism modulates voltage-gated sodium channels and enhances GABA_A receptor activity, resulting in higher seizure response rates, particularly in refractory cases, differentiating it from traditional monotherapies.

2. Are there any notable safety concerns associated with Cenobamate?
While generally well-tolerated, adverse events like dizziness and somnolence are common, especially during titration. Serious concerns include hypersensitivity reactions and potential drug-drug interactions, necessitating careful patient monitoring.

3. Is Cenobamate approved for pediatric use?
Currently, Cenobamate’s approval is limited to adults. Clinical trials in pediatric populations are ongoing, but regulatory approval has not yet been granted.

4. What are the main markets for Cenobamate outside the US?
Europe, Japan, and select Asian markets are the primary targets for international expansion, with regulatory submissions underway in several jurisdictions.

5. Could Cenobamate be used for other neurological indications?
While primarily indicated for focal seizures, ongoing research is exploring its efficacy in generalized epilepsies and other neurological conditions, although clinical validation is pending.

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References

1. UCB. (2022). Post-marketing safety and effectiveness data on Cenobamate.
2. SK Biopharmaceuticals. (2021). Open-label extension study results in epilepsy patients.
3. Pharmacokinetic studies on Cenobamate interactions. Journal of Epilepsy & Behavior.
4. Market analytics reports by IQVIA. (2022). Epilepsy drug market dynamics.
5. UCB Pricing Data. (2023). Cenobamate wholesale pricing.
6. Grand View Research. (2022). Global epilepsy drugs market analysis and forecast.

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In conclusion, Cenobamate’s clinical and market trajectories suggest a promising role as a next-generation epilepsy therapy, with ongoing trials and geographic expansion reinforcing its growth prospects. Stakeholders should keep abreast of evolving clinical data, safety profiles, and regulatory decisions to capitalize on emerging opportunities.