Recent Updates
Recently added Catalysts

CAL-263

Phase 1

Allergic Rhinitis | Small molecule | Other |Gilead Sciences, Inc.|Last Updated: May 5, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01066611Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental ChamberPHASE1 COMPLETED 48Jan 1, 2010Apr 1, 2010May 5, 20111 Austria
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Evaluate the safety of CAL-263 in allergic rhinitis subjects
46 days
Secondary Endpoints
Determine the efficacy of CAL-263 on total nasal symptom scores following an allergen challenge in allergic rhinitis subjects
7 days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORCAL-263
2PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
CAL-263DRUGCAL-263 10 mg or placebo once daily for 7 days
PlaceboDRUGCAL-263 10 mg or placebo once daily for 7 days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Age \>18 and \<55 years 2. Has a history of seasonal allergic rhinitis for at least 2 years 3. Has sensitivity to grass pollen demonstrated by a positive response to skin prick testing 4. Has a positive Radio Allergen Sorbent Test (class 2 or greater) for grass pollen during ...

Countries:Austria
Unlock Eligibility Criteria
Competitive Landscape -Allergic Rhinitis 4 trials