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QVM149

Phase 3

Asthma | Small molecule | Respiratory |Novartis AG|Last Updated: Feb 3, 2026

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment1,826
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05776927A Study to Evaluate the Efficacy and Safety of QVM149 (Indacaterol Acetate / Glycopyrronium Bromide / Mometasone Furoate) Versus Salmeterol Xinafoate/Fluticasone Propionate in Children From 12 Years to Less Than 18 Years of Age With Asthma.PHASE3 NOT YET_RECRUITING 304May 29, 2026Dec 24, 2029Feb 3, 2026 -
NCT03158311Study to Compare QVM149 and Free Triple Combination of Salmeterol/Fluticasone + TiotropiumPHASE3 COMPLETED 1,426Feb 5, 2018Jul 19, 2019Oct 8, 2021163 Argentina, Chile +18
NCT03100825A Long-term Safety Study of QVM149 in Japanese Patients With AsthmaPHASE3 COMPLETED 96Apr 28, 2017Apr 8, 2019Apr 7, 202025 Japan
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Study Endpoints
Primary Endpoints
Change from Baseline in Trough FEV1 at Week 26.
Baseline, Week 26

FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing.

Change From Baseline in Asthma Quality of Life Questionnaire (AQLQ) Total Score
Baseline and Week 24

The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma, with a recall time of two weeks and each question to be answered on a 7-point scale, where 1=totally limited/problems all the time and 7= not at all limited/no problems. It consists of 4 domains: symptoms, activity limitation, emotional funtion, and emotional stimuli. The overall score is calculated as the mean of 32 items. Higher AQLQ scores indicate better health-related quality of life.

Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
Up to 52 Weeks

An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as adverse events started on or after the time of the first inhalation of study drug but no later than 7 days after the last administration (30 days in the case of SAEs). SAE was defined as any adverse event (appearance of \[or worsening of any pre-existing\]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.

Secondary Endpoints
Change from Baseline in Trough FEV1 at Week 52
Baseline, Week 52
Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 26 and Week 52
Baseline, Week 26, Week 52
Change from Baseline in average Morning and Evening PEFR over 26 weeks and over 52 weeks treatment periods
Baseline, Week 26, Week 52
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
QVM149EXPERIMENTALQVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler® and Placebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
Salmeterol Xinafoate / Fluticasone Propionate ArmACTIVE_COMPARATORSalmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler® and Placebo to QVM149 (Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg ) od delivered via Breezhaler®.
QVM149 150/50/80 μgEXPERIMENTALQVM149 150/50/80 μg o.d. delivered via Concept1
QVM149 150/50/160 μgEXPERIMENTALQVM149 150/50/160 μg o.d. delivered via Concept1
Salmeterol/fluticasone 50/500 μg plus tiotropium 5 μgACTIVE_COMPARATORSalmeterol/fluticasone 50/500 μg b.i.d. delivered via Accuhaler® plus tiotropium 5 μg o.d. delivered via Respimat®
Interventions
NameTypeDescription
QVM149DRUGQVM149: Indacaterol as acetate 150 µg / glycopyrronium as bromide 50 µg / mometasone furoate 160 µg od delivered via Breezhaler®
Salmeterol Xinafoate / Fluticasone PropionateDRUGSalmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
Placebo to QVM149DRUGPlacebo to QVM149: 150 μg Indacaterol Acetate / 50 μg Glycopyrronium Bromide / 160 μg Mometasone Furoate od delivered via Breezhaler®
Placebo to Salmeterol Xinafoate / Fluticasone PropionateDRUGPlacebo to Salmeterol Xinafoate 50 μg / Fluticasone Propionate 500 μg bid delivered via Girohaler®
Run-In MedicationDRUGSalmeterol Xinafoate 50 μg / Fluticasone Propionate 250μg bid delivered via Girohaler® or equivalent DPI device
Rescue MedicationDRUGSalbutamol 100μg / Albuterol 90μg
Concept 1 DeviceDEVICEConcept1 (Breezhaler) used for QVM149 and placebo delivery
GirohalerDEVICEGirohaler for Comparator and Placebo delivery.
Salmeterol/fluticasone plus tiotropiumDRUGFree triple arm of salmeterol / fluticasone plus tiotropium
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Eligibility Criteria
Age Range12 Years — 17 Years
SexALL
Healthy VolunteersNo

Inclusion criteria Participants eligible for inclusion in this study must meet all of the following criteria: 1. Male and female adolescent subjects aged from equal to or greater than 12 years old to less than 18 years old at Screening visit. 2. Written and signed informed consent by parent(s)/leg...

Countries:ArgentinaChileColombiaCzechiaGermanyGreeceHungaryIndiaIsraelMexicoPeruPolandRussiaSerbiaSlovakiaSouth AfricaSpainTaiwanTurkey (Türkiye)VietnamJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05776927primaryCompletionDate: changed
LOWMay 24, 2026NCT05776927studyFirstPostDate: changed