Last reviewed 2026-06-01 · How we verify

indacaterol maleate/mometasone furoate

Novartis · Phase 3 active Small molecule Under review

indacaterol maleate/mometasone furoate is a Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination Small molecule drug developed by Novartis. It is currently in Phase 3 development for Chronic obstructive pulmonary disease (COPD), Asthma. Also known as: QMF149.

Indacaterol maleate is a long-acting beta2-adrenergic receptor agonist, while mometasone furoate is an inhaled corticosteroid.

Indacaterol maleate/mometasone furoate is a combination medication that acts as a glucocorticoid receptor agonist, which is a type of small molecule. It is used to treat asthma, as indicated by clinical trials on the ClinicalTrials.gov database.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Novartis is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	indacaterol maleate/mometasone furoate
Also known as	QMF149
Sponsor	Novartis
Drug class	Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination
Target	beta2-adrenergic receptor
Modality	Small molecule
Therapeutic area	Respiratory
Phase	Phase 3

Mechanism of action

Indacaterol maleate works by stimulating the beta2-adrenergic receptors in the lungs, causing bronchodilation and improving airflow. Mometasone furoate, on the other hand, reduces inflammation in the airways by inhibiting the production of pro-inflammatory cytokines.

Approved indications

Chronic obstructive pulmonary disease (COPD)
Asthma

Common side effects

Cough
Headache
Oral candidiasis
Upper respiratory tract infection
Nausea

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

indacaterol maleate/mometasone furoate CI brief — competitive landscape report
indacaterol maleate/mometasone furoate updates RSS · CI watch RSS
Novartis portfolio CI

Frequently asked questions about indacaterol maleate/mometasone furoate

What is indacaterol maleate/mometasone furoate?

indacaterol maleate/mometasone furoate is a Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination drug developed by Novartis, indicated for Chronic obstructive pulmonary disease (COPD), Asthma.

How does indacaterol maleate/mometasone furoate work?

Indacaterol maleate is a long-acting beta2-adrenergic receptor agonist, while mometasone furoate is an inhaled corticosteroid.

What is indacaterol maleate/mometasone furoate used for?

indacaterol maleate/mometasone furoate is indicated for Chronic obstructive pulmonary disease (COPD), Asthma.

Who makes indacaterol maleate/mometasone furoate?

indacaterol maleate/mometasone furoate is developed by Novartis (see full Novartis pipeline at /company/novartis).

Is indacaterol maleate/mometasone furoate also known as anything else?

indacaterol maleate/mometasone furoate is also known as QMF149.

What drug class is indacaterol maleate/mometasone furoate in?

indacaterol maleate/mometasone furoate belongs to the Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination class. See all Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination drugs at /class/long-acting-beta2-adrenergic-receptor-agonist-inhaled-corticosteroid-combination.

What development phase is indacaterol maleate/mometasone furoate in?

indacaterol maleate/mometasone furoate is in Phase 3.

What are the side effects of indacaterol maleate/mometasone furoate?

Common side effects of indacaterol maleate/mometasone furoate include Cough, Headache, Oral candidiasis, Upper respiratory tract infection, Nausea.

What does indacaterol maleate/mometasone furoate target?

indacaterol maleate/mometasone furoate targets beta2-adrenergic receptor and is a Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination.

Drug class: All Long-acting beta2-adrenergic receptor agonist/inhaled corticosteroid combination drugs
Target: All drugs targeting beta2-adrenergic receptor
Manufacturer: Novartis — full pipeline
Therapeutic area: All drugs in Respiratory
Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
Indication: Drugs for Asthma
Also known as: QMF149

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing