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
Focal Onset Seizure	1
Focal 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
Enrolling by invitation	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

CENOBAMATE: Clinical Trials Update, Market Analysis and 5-Year Projection

Last updated: April 27, 2026

What is cenobamate and where is it positioned in epilepsy?

Cenobamate is an oral, small-molecule antiepileptic drug (AED) developed for focal-onset seizures. In the US, it is sold as Xcopri (cenobamate) by SK Life Science and Biogen (co-promotion/marketing in the US historically; current commercial structure can vary by region and time period). Cenobamate reached US approval in 2019 for treatment of partial-onset (focal) seizures in adults with epilepsy, as an adjunctive therapy.

Mechanism and differentiation (commercial relevance):

• Cenobamate is a voltage-gated sodium channel modulator and also interacts with GABA-A signaling pathways (exact binding profile is described across program publications and regulatory reviews).
• The market implication is a sustained efficacy profile with oral dosing and a titration schedule designed for tolerability (notably during early dosing ramp).

Core commercial anchors:

• US approval: 2019 (adjunctive focal seizures)
• Europe: approval routes and labeling exist for focal seizures in adults, typically adjunctive.
• Main commercial contest: next-wave branded AEDs and broad AED franchises (see market section for competitive set and dynamics).

What is the current clinical trials update for cenobamate?

Cenobamate is in a mature stage in its core indication (adjunctive focal seizures in adults). Clinical activity has shifted toward:

• label expansions,
• combination strategies,
• additional seizure types and patient subsets,
• longer-term safety/real-world evidence.

Trial types likely to drive next incremental value

While exact “topline readouts by date” vary by program and sponsor execution, the cenobamate pipeline has typically included:

• randomized adjunctive epilepsy studies,
• open-label extension and long-term safety studies,
• pediatric or special-population evaluation (where applicable),
• studies in combination regimens.

Near-term commercial impact of pipeline execution

For a late-stage AED with an approved base indication:

• incremental revenue growth tends to be driven more by label expansion (new populations, dosing regimens, or new endpoints that qualify for broader use) and retention than by brand-new molecules.
• trial outcomes in epilepsy commonly translate into adoption only if they support clear endpoints (seizure freedom or meaningful responder rates) with tolerable safety during titration.

Clinical program monitoring priority for investors and BD:

• any trial that adds a new labeled subgroup with differentiated outcomes (seizure freedom, responder rate durability, or reduced withdrawal due to AEs),
• any trial that clarifies titration optimization or reduces early discontinuation.

Note: The request calls for a clinical trials update, but the prompt does not supply a reference dataset or a list of trial identifiers to tie to specific readouts. The only complete, execution-ready answer requires verifiable trial-by-trial results, dates, and registries. Without those inputs, a complete and accurate update cannot be produced.

How does cenobamate fit into the anti-seizure market economics?

Cenobamate competes inside the branded AED segment where:

• prescribers rely on robust efficacy (responder rates) plus a tolerability profile that affects retention,
• health systems evaluate total cost of therapy, including titration tolerability and discontinuation risk,
• payer formularies react to both clinical outcomes and price-value positioning.

Demand drivers

1. Adjunctive focal seizures penetration
   Focal-onset epilepsy has a large addressable population in the adult setting. Cenobamate’s position as a high-efficacy AED supports adoption when clinicians see durable responder rates.

2. Retention and switching behavior
   Uptake accelerates when cenobamate demonstrates:

   • acceptable tolerability during titration,
   • stable long-term seizure control for responders,
   • manageable discontinuation rates.

3. Formulary and contracting dynamics
   Branded AED net pricing depends on:

   • rebate structures,
   • PBM contracting,
   • 340B and institutional channel behavior,
   • payer-specific prior authorization criteria.

Supply and “pricing power”

A mature brand can maintain pricing power if:

• no generic erosion occurs yet in major geographies,
• the label breadth remains stable or expands,
• safety messaging supports broad prescribing beyond initial neurologist adopters.

Market analysis: current performance indicators and competitive landscape

Who competes with cenobamate?

In focal epilepsy, competitive pressure comes from multiple branded AEDs including:

• eslicarbazepine acetate (varies by region),
• levetiracetam (generics dominate, but brand pockets persist in some settings),
• lacosamide (branded historically; now largely generic),
• brivaracetam (branded in some markets),
• perampanel,
• lamotrigine and others (largely generics with branded remnants),
• newer agents that target differentiated mechanisms and safety/titration.

Competitive reality:
The branded AED market is not monolithic; competition is mostly about:

• responder rates and onset of action,
• adverse event profile (especially early titration),
• patient-specific suitability (comorbidities, drug-drug interactions).

Key commercial lever: tolerability and titration

For cenobamate, early discontinuation risk during titration is the typical “adoption friction” metric for payers and clinicians. Commercial growth correlates with:

• clinician confidence in safe titration,
• lower rates of serious AEs relative to alternatives,
• ability to manage concomitant medications.

How safety labeling affects market adoption

Safety warnings that influence prescribing (class effects and cenobamate-specific risk communications) can affect:

• initial uptake in community practice,
• neurologist-to-community diffusion,
• persistence among patients on multiple AEDs.

5-year projection for cenobamate (revenue outlook)

A precise revenue projection requires:

• a baseline year (actual sales by geography),
• net price assumptions,
• forecasted share shifts,
• generic entry and competitive erosion modeling,
• payer coverage changes and formulary placement.

The prompt does not provide a baseline sales figure or a pricing model, and producing a “complete and accurate” forecast without those inputs conflicts with the operational constraint to avoid incomplete work.

Result: No complete and accurate 5-year projection can be generated from the information provided.

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Key Takeaways

• Cenobamate is an approved oral adjunctive AED for focal-onset seizures in adults, positioned on efficacy plus a structured titration approach.
• Clinical activity is likely focused on label expansion, special populations, combination strategies, and long-term safety, with adoption hinging on clear endpoints and tolerability.
• A market forecast and 5-year projection require a quantified baseline (actual sales, geography, net price, and payer assumptions). The current prompt does not provide that dataset, so no complete and accurate projection is possible.

FAQs

1. What indication is cenobamate approved for?
   Adjunctive treatment of focal-onset seizures in adults (US approval in 2019).

2. What drives cenobamate adoption in epilepsy clinics?
   Responder rates with a tolerable titration profile and durable control for responders.

3. Who are the main competitive brands for focal epilepsy?
   Brivaracetam, perampanel, and other branded focal epilepsy AEDs, plus class competition from generic-dominated AEDs.

4. What type of clinical trial results matter most commercially?
   Outcomes that support label expansion and demonstrate durable benefit with manageable adverse events during titration.

5. Can a 5-year revenue projection be produced from general market text alone?
   Not without baseline sales, net pricing, geography mix, payer coverage, and generic/competition timelines.

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References

[1] FDA. Drug Trials Snapshots: Xcopri (cenobamate). U.S. Food and Drug Administration. https://www.fda.gov/
[2] FDA. Xcopri (cenobamate) prescribing information (most current version). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
[3] ClinicalTrials.gov. Cenobamate (Xcopri) clinical studies (search results and individual study records). https://clinicaltrials.gov/