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SPN-817

Phase 2

Focal Onset Seizures | Small molecule | Neurology |Supernus Pharmaceuticals, Inc.|Last Updated: Jun 1, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment316
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07141329SPN-817 Open-Label Extension Study in Adults With Focal Onset SeizuresPHASE2 RECRUITING 100 — — Jul 30, 2025Dec 31, 2027Oct 10, 20251 United States
NCT06798896RENAISSANCE 2: SPN-817 Phase 2, Double-Blind, Placebo-Controlled Study in Adults With Focal Onset SeizuresPHASE2 RECRUITING 216 — — Dec 30, 2024Aug 1, 2027Jun 1, 20261 United States
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Study Endpoints
Primary Endpoints
Incidence of treatment-emergent adverse events
Week 1-Week 52

The percent of participants who took at least one dose of SPN-817 and reported at least one adverse event during the 1-year SPN-817 Treatment Period

Percent change (PCH) from baseline in focal onset seizure frequency per 28 days over the Maintenance Period
Baseline and Maintenance Period (Maintenance Week 1-14)

Percent change in 28-day frequency of focal seizures during the 14 week Maintenance Period relative to baseline

Secondary Endpoints
Percent change (PCH) from baseline in quantifiable focal onset seizure frequency per 28 days over the 1-year SPN-817 Treatment Period
Baseline and Treatment Period (Week 1-52)
Proportion of participants experiencing ≥50% reduction in focal seizure frequency per 28 days from baseline
Baseline and Treatment Period (Week 1-52)
Proportion of participants experiencing seizure freedom
Baseline and Treatment Period (Week 1-52)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
SPN-817EXPERIMENTALSPN-817, bid
PlaceboPLACEBO_COMPARATORPlacebo, bid
Interventions
NameTypeDescription
SPN-817DRUGSPN-817 starting at 0.25 mg bid up to 4.00 mg bid
PlaceboDRUGPlacebo, bid
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Completed antecedent SPN-817 double-blind study 2. Taking a stable dosage regimen (maintained during the antecedent study) of at least one antiseizure medication (ASM) and no more than 4 ASMs Exclusion Criteria: 1. Has current nonepileptic events that could be confused by t...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMJun 2, 2026NCT06798896Enrollment: 258 → 216
MEDIUMJun 2, 2026NCT06798896Enrollment: 258 → 216
MEDIUMJun 2, 2026NCT06798896Enrollment: 258 → 216
LOWMay 26, 2026NCT07141329primaryCompletionDate: changed
LOWMay 26, 2026NCT06798896primaryCompletionDate: changed
LOWMay 24, 2026NCT07141329studyFirstPostDate: changed
LOWMay 24, 2026NCT06798896studyFirstPostDate: changed