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Ponesimod

Phase 3

Moderate-to-severe Chronic Plaque Psoriasis | Small molecule | Immunology |Vanda Pharmaceuticals Inc.|Last Updated: Jan 23, 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
UNCONTROLLED
Total Trials1
Total Enrollment300
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07362017Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque PsoriasisPHASE3 NOT YET_RECRUITING 300Jan 1, 2026Dec 1, 2028Jan 23, 2026 -
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Study Endpoints
Primary Endpoints
Safety and tolerability of ponesimod as measured by reporting of adverse events (AEs)
Through study completion, approximately 1 year

Safety will be assessed based on frequency of treatment-emergent adverse events and serious adverse events, and frequency of clinically notable abnormal vital signs, blood chemistry, hematology, urology, and ECGs

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PonesimodEXPERIMENTALPonesimod
Interventions
NameTypeDescription
PonesimodDRUGOral Tablet
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Male and female subjects aged 18-65 years, inclusive * BMI \>18 and \<40 * Minimum affected BSA of 10% * PASI score ≥ 12 * PGA ≥ 3 * Diagnosed with moderate-to-severe plaque psoriasis Exclusion Criteria: * Diagnosis of generalized erythrodermic, generalized pustular (von Zum...

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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07362017primaryCompletionDate: changed
LOWMay 24, 2026NCT07362017studyFirstPostDate: changed