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Nolpitantium

Phase 2

Ulcerative Colitis | Small molecule | Immunology |Sanofi|Last Updated: Dec 10, 2008

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment307
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00232258Nolpitantium Besylate In Patients With Ulcerative Colitis a Double-Blind, Placebo Controlled Efficacy and Safety StudyPHASE2 COMPLETED 307Apr 1, 2005Sep 1, 2006Dec 10, 200814 Argentina, Belgium +12
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Study Endpoints
Primary Endpoints
Clinical remission at 8 weeks defined as a clinical Mayo subscore </= 1
Secondary Endpoints
Clinical response defined as at least 3 point reduction from baseline on Clinical Mayo Sub-score
Global change in overall Disease Activity Index
Abdominal pain score at 8 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Nolpitantium besylateDRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Age at least 18 years * Ulcerative colitis of at least 6 months duration * Patient's ulcerative colitis should remain active while taking 5-ASA or sulfasalazine for at least 4 week * If taking corticosteroids, dose must be stable for at least 2 weeks prior to enrollment and no...

Countries:ArgentinaBelgiumBrazilCanadaChileCzechiaEstoniaHungaryItalyRussiaSingaporeSouth AfricaSpainSweden
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