Recent Updates
Recently added Catalysts

FEX60/PE10

Phase 3

Rhinitis Allergic | Small molecule | Other |Sanofi|Last Updated: Nov 30, 2015

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment105
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02401191A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic RhinitisPHASE3 COMPLETED 105Mar 1, 2015Jul 1, 2015Nov 30, 20151 Japan
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Number of adverse events (Solicited AE reporting)
From intake of FEX60/PE10 up to approximately 2 weeks
Changes from baseline in the nasal congestion score based on the patient's symptom diary
After 2 weeks treatment
Secondary Endpoints
Change from baseline in the total score of 3 nasal symptoms (sneezing, rhinorrhea, and nasal congestion)
After 2 weeks treatment
Change in the total score of 3 nasal symptoms on a daily basis
After 2 weeks treatment
Change in the total score of 3 nasal symptoms during daytime
After 2 weeks treatment
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
FEX60/PE10EXPERIMENTALInternal use of FEX60/PE10 combination tablet will be administered twice daily (1 tablet per intake) for 2 weeks
Interventions
NameTypeDescription
FEX60/PE10DRUGPharmaceutical form:tablet Route of administration: oral
Unlock Study Design Details
Eligibility Criteria
Age Range15 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion criteria: * Outpatients with a history of seasonal or perennial allergic rhinitis for at least 1 year confirmed by positive skin prick test to out or indoor allergens (wheal ≥3mm compared to control \[diluent\]) or positive specific IgE Antibody test (ie, radioallergosorbent test \[RAST\]...

Countries:Japan
Unlock Eligibility Criteria