CLINICAL TRIALS PROFILE FOR XCOPRI

All Clinical Trials for XCOPRI

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04903314 ↗	Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures	Recruiting	SK Life Science, Inc.	Phase 1	2021-05-27	The primary objective of this study is to assess the pharmacokinetics of cenobamate (YKP3089) in pediatric subjects with partial-onset (focal) seizures following single and multiple-dosing.
NCT05067634 ↗	Safety and Efficacy Extension Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures	Not yet recruiting	SK Life Science, Inc.	Phase 3	2021-11-01	Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Clinical Trial Conditions for XCOPRI

Condition Name

Condition Name for XCOPRI
Intervention	Trials
Partial Epilepsy	2

Condition MeSH

Condition MeSH for XCOPRI
Intervention	Trials
Epilepsies, Partial	2
Seizures	2

Clinical Trial Locations for XCOPRI

Trials by Country

Trials by Country for XCOPRI
Location	Trials
United States	3

Trials by US State

Trials by US State for XCOPRI
Location	Trials
Maryland	2
Tennessee	1

Clinical Trial Progress for XCOPRI

Clinical Trial Phase

Clinical Trial Phase for XCOPRI
Clinical Trial Phase	Trials
Phase 3	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for XCOPRI
Clinical Trial Phase	Trials
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for XCOPRI

Sponsor Name

Sponsor Name for XCOPRI
Sponsor	Trials
SK Life Science, Inc.	2

Sponsor Type

Sponsor Type for XCOPRI
Sponsor	Trials
Industry	2

Last updated: July 27, 2026

XCOPRI (cenobamate) clinical trials update, market analysis and revenue projection (2026-2035)

XCOPRI (cenobamate) is an oral antiseizure medicine for focal-onset seizures in adults, with commercialization dominated by U.S. Uptake after launch and limited competitive pressure from other focal epilepsy branded and generic entrants. Current market upside is driven by (i) expansion across payer formularies, (ii) titration-adherence improvements from real-world prescribing, and (iii) line extensions tied to dosing convenience and prescriber experience. Commercial downside risks include (i) the pace of uptake versus expectations, (ii) formulary tiering outcomes, and (iii) pipeline pressure in focal epilepsy. A defensible revenue base case requires binding estimates for country penetration and net price, which are not determinable from the information available in this prompt.

What is the latest XCOPRI (cenobamate) clinical trials status in focal-onset seizures?

Latest determinable position: Not provided.

Which XCOPRI phase 3 or phase 2 trials are actively recruiting or reporting results?

Not provided.

Are there updates for XCOPRI in adjunctive therapy vs monotherapy?

Not provided.

Is XCOPRI being studied for pediatric use or expanded indications beyond focal-onset seizures in adults?

Not provided.

What XCOPRI (cenobamate) clinical trial readouts have changed the competitive landscape?

Not provided.

What endpoints were reported (seizure reduction, responder rate, median time to onset)?

Not provided.

How do XCOPRI efficacy results compare with other focal epilepsy drugs in head-to-head or indirect comparisons?

Not provided.

When will XCOPRI (cenobamate) face regulatory or labeling expansion milestones?

Not provided.

Has FDA updated XCOPRI labeling with new dosing, safety communications, or restricted use?

Not provided.

Are there EU or other region submissions tied to new indications or populations?

Not provided.

What patents protect XCOPRI (cenobamate) in the US, and when do key exclusivity dates land?

Not provided.

How strong is the XCOPRI patent estate for formulations, methods of use, and manufacturing?

Not provided.

What is the Orange Book status of XCOPRI (cenobamate)?

Not provided.

Are there Paragraph IV challenges or generic launch risks for XCOPRI?

Not provided.

What generic entry risks exist for XCOPRI (cenobamate) and how fast could generics erode net price?

Not provided.

Which companies are likely to challenge XCOPRI via ANDA or file to market?

Not provided.

What settlement agreements or court rulings affect launch timing?

Not provided.

How does XCOPRI (cenobamate) market share compare with branded focal epilepsy competitors?

Not provided.

Which rivals most directly compete for cenobamate’s target population?

Not provided.

How do payer coverage and step edits influence XCOPRI’s adoption curve?

Not provided.

How much revenue does XCOPRI (cenobamate) generate and what is the forecast to 2035?

Not provided.

Base case revenue projection drivers for XCOPRI

Not provided.

Downside case and upside case assumptions (penetration, net price, persistence)

Not provided.

Scenario sensitivity: what happens if uptake slows or net price compresses?

Not provided.

What are the key growth vectors for XCOPRI (cenobamate) in the US and international markets?

Not provided.

Formulary tiering, PBM coverage, and utilization management

Not provided.

Prescriber adoption dynamics and titration adherence effects

Not provided.

Institutional formularies vs community practice patterns

Not provided.

What manufacturing or supply constraints could affect XCOPRI (cenobamate) sales?

Not provided.

CDMO or internal capacity expansion for cenobamate

Not provided.

Any known quality events, recalls, or supply interruptions

Not provided.

Key Takeaways

Not provided.

FAQs

1. What is XCOPRI cenobamate’s current FDA-approved indication and dosing regimen? Not provided.
2. What safety or drug interaction issues (for example, CYP450-related warnings) affect XCOPRI prescribing? Not provided.
3. Is XCOPRI covered under Medicare Part D or commercial preferred drug lists in major PBMs? Not provided.
4. Are there ongoing XCOPRI trials in additional patient populations or new endpoints? Not provided.
5. What is the expected impact of generic competition on XCOPRI net revenue? Not provided.

References (APA)

Not provided.