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indacaterol maleate / mometasone furoate

Unknown / undisclosed

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Evidence outlook · lead readout

NCT02554786 · Asthma

The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.

NCT02554786: This randomized, double-blind, active-controlled Phase 3 trial in 2,216 patients with asthma compared the combination inhaler indacaterol/mometasone furoate with mometasone furoate alone at matched steroid doses. Lung function, measured as trough FEV1 at 26 weeks, improved significantly more with the combination at both dose levels tested (p<0.001 for each comparison).

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Competitive landscape

65 competitors in this universe: 5 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 38 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Indacaterol Maleate / Mometasone Furoate: this drugPhase 3—Glucocorticoid receptor / Beta-2 adrenergic receptor
Albuterol / Budesonide (Airsupra)ApprovedCombinationBeta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
Fluticasone Furoate / VilanterolApprovedSmall moleculeBeta-2 adrenergic receptor, Glucocorticoid receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
Fluticasone Propionate / Salmeterol (Advair HFA)ApprovedCombinationGlucocorticoid receptor, Beta-2 adrenergic receptor, Glucocorticoid receptor / Beta-2 adrenergic receptor
GW815SF (Advair HFA)ApprovedSmall moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor
Fluticasone Propionate / SalmeterolPhase 3Small moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor
Albuterol (Armstrong Albuterol HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol HFA (Armstrong's)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol HFA (Proventil HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Armstrong)ApprovedSmall moleculeBeta-2 adrenergic receptor
Albuterol Sulfate (Provenetil-HFA)ApprovedSmall moleculeBeta-2 adrenergic receptor
AminophyllineApprovedSmall moleculePhosphodiesterase (multi-subtype)
Beclomethasone (QVAR)ApprovedSmall moleculeGlucocorticoid receptor
Beclomethasone Dipropionate / Formoterol Fumarate / GlycopyrrolateApprovedSmall moleculeGlucocorticoid receptor / Beta-2 adrenergic receptor / Muscarinic M3 receptor (ICS/LABA/LAMA triple combination)
Benralizumab (Fasenra)ApprovedMonoclonal antibodyIL-5 receptor alpha, IL-5 receptor alpha (IL-5Rα / CD125); Fc region additionally engages FcγRIIIa on NK cells (ADCC), IL-5 receptor alpha (IL5RA) on eosinophils/basophils
Budesonide (Pulmicort)ApprovedSmall moleculeGlucocorticoid receptor agonist

…and 50 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2028 (1)
February 2028 (1)
Phase 3AsthmaRecruiting
Est. primary completion 2028-02-01 · NCT05562466 · CT.gov ↗
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.

Phase 3 (4)
Phase 2 (6)
Used as active comparator (2)