Recent Updates
Recently added Catalysts

FF/UMEC/VI

Phase 3

Asthma | Small molecule | Respiratory |Grace Therapeutics, Inc.|Last Updated: Aug 29, 2025

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 Enrollment31
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04651777Evaluation of Triple Therapy Using Magnetic Resonance Imaging in AsthmaPHASE3 ACTIVE NOT_RECRUITING 31Aug 8, 2022Dec 1, 2025Aug 29, 20251 Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change From Baseline Airway Function Measured Using 129-Xenon MRI Ventilation Defect Percent at the End of 6 Weeks of Treatment With FF/UMEC/VI 200/62.5/25ug Once Daily
Day 0 to day 42

Change in VDP

Secondary Endpoints
Change From Baseline Forced Expiration Volume in One Second
Baseline and Day 42
Change From Baseline Forced Vital Capacity
Baseline and Day 42
Change From Baseline Residual Volume
Baseline and Day 42
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants with poorly controlled moderate to severe asthmaEXPERIMENTALParticipants with poorly controlled moderate to severe asthma will be evaluated during and after a six week trial of triple therapy (ICS/LABA/LAMA) for changes in 129Xe MRI ventilation percent defect, pulmonary function measurements.
Interventions
NameTypeDescription
FF/UMEC/VIDRUGThe investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol. The drug is delivered in an Ellipta inhaler in a single dose once daily.
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Participant understands study procedures and is willing to participate in the study as indicated by the participant's signature * Provision of written, informed consent prior to any study specific procedures * Males and females with a clinical diagnosis of eosinophilic asthma ...

Countries:Canada
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04651777primaryCompletionDate: changed
LOWMay 24, 2026NCT04651777studyFirstPostDate: changed