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Bilastine

Phase 2

Seasonal Allergic Rhinitis | Small molecule | Other |Merck & Company, Inc.|Last Updated: Feb 15, 2019

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_CONTROLLED
Total Trials1
Total Enrollment805
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00574379Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SARPHASE2 COMPLETED 805Dec 1, 2007Mar 1, 2008Feb 15, 201913 United States
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Study Endpoints
Primary Endpoints
Change in nasal symptom scores
14 days
Secondary Endpoints
Change in ocular symptom scores and quality of life scores; standard safety assessments
14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALBilastine 20mg once per day
2EXPERIMENTALBilastine 20mg twice per day
3EXPERIMENTALBilastine 10mg once per day
4EXPERIMENTALBilastine 10mg twice per day
5PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BilastineDRUGBilastine 10 or 20mg, once or twice daily for 14 days. Tablets
PlaceboDRUGPlacebo tablets twice daily for 14 days
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * clinical history of Seasonal Allergic Rhinoconjunctivitis with seasonal onset and offset of nasal allergy symptoms * documentation of a positive skin test within one year of screening to Mountain Cedar allergen Exclusion Criteria: * significant medical condition * significan...

Countries:United States
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