Recent Updates
Recently added Catalysts

Ifetroban,

Phase 2

Aspirin Exacerbated Respiratory Disease (AERD) | Small molecule | Other |Cumberland Pharmaceuticals Inc.|Last Updated: May 15, 2017

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_CONTROLLEDBiomarker
Total Trials1
Total Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02216357Trial to Determine the Safety of Oral Ifetroban in Patients With a History of Aspirin Exacerbated Respiratory DiseasePHASE2 COMPLETED 19 — — Aug 1, 2014Jan 1, 2016May 15, 20173 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Proportion of Patients Who Experience a ≥ 20% Decrease in Forced Expiratory Volume in One Second (FEV1) Compared to Baseline Following a Dose of Investigational Medicinal Product (IMP) (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
Study Day 2
Secondary Endpoints
Proportion of Patients With a ≥ 25% Decrease in Peak Nasal Inspiratory Flow Rate Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
Up to Study Day 2
Proportion of Patients With a ≥ 25% Increase in Total Nasal Symptom Score (TNSS) Compared to Baseline Following a Dose of IMP (Study Day 1 or 2) Prior to Initiation of the Aspirin Challenge
Up to Study Day 2
Incidence and Severity of Treatment-emergent Adverse Events
Up to Study Day 7
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ifetroban, Oral CapsuleACTIVE_COMPARATORIfetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.
Placebo, Oral CapsulePLACEBO_COMPARATORPlacebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.
Interventions
NameTypeDescription
Ifetroban, Oral CapsuleDRUG -
Placebo, Oral CapsuleDRUG -
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Adults with a history of physician-diagnosed stable asthma (FEV1 of at least 1.25 liters and 60% or better than predicted\* on two previous visits with no more than a 10% variation in those values, no increase in baseline dose of oral glucocorticoids for asthma for at least t...

Countries:United States
Unlock Eligibility Criteria