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vormatrogine

Phase 3

Epilepsy, Tonic-Clonic | Small molecule | Neurology |Praxis Precision Medicines, Inc.|Last Updated: Dec 17, 2025

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
UNCONTROLLED
Total Trials1
Total Enrollment700
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07287163Clinical Trial of Vormatrigine in Adult Patients With EpilepsyPHASE3 ENROLLING BY_INVITATION 700Oct 27, 2025Dec 31, 2028Dec 17, 202520 United States, Germany +3
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of vormatrigine in adults with focal or primary generalized tonic-clonic seizures
Up to 2 years

Incidence and severity of TEAEs including discontinuation of study drug due to TEAEs

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label 30 mg/day vormatrogine for up to 2 yearsEXPERIMENTALParticipants who meet all eligibility criteria will receive 30 mg of vormatrogine for up to 2 years.
Interventions
NameTypeDescription
vormatrogineDRUGOnce daily oral
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Eligibility Criteria
Age Range18 Years — 85 Years
SexALL
Healthy VolunteersNo
Study Sites20

Inclusion Criteria: * Participant who completed an eligible clinical trial (unless agreed by the sponsor medical monitor), including PRAX-628-212, PRAX-628-321 or other vormatrigine trials, or participant who has received vormatrigine outside of an eligible clinical trial (such as an expanded acces...

Countries:United StatesGermanyItalyPolandSpain
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07287163primaryCompletionDate: changed
LOWMay 24, 2026NCT07287163studyFirstPostDate: changed