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Drug

Indacaterol

EU marketing authorisation ended
RxNorm1114326ChEMBLCHEMBL1095777ATCR03AC18UNII8OR09251MQ
2
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

EU marketing authorisation withdrawn: Hirobriz Breezhaler (EMA)

Regulatory2026-10-30EMA

EU marketing authorisation withdrawn: Oslif Breezhaler (EMA)

Regulatory2026-10-30EMA

Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD

Clinical trial2021-06-01Completed · ClinicalTrials.gov

A 2-Part, Randomised, Placebo-Controlled, Safety, Tolerability, Pharmacokinetic And Pharmacodynamic Study Of LAS190792 Delivered By Inhalation In Asthmatic And Chronic Obstructive Pulmonary Disease (COPD) Subjects

Clinical trial2019-06-21Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo Controlled, Multicentre Study to Determine the Effect of QVA149 on Lung Function in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Clinical trial2018-07-26Results posted · ClinicalTrials.gov

Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD

Clinical trial2018-03-01Results posted · ClinicalTrials.gov

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

Clinical trial2017-07-11Results posted · ClinicalTrials.gov

24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD

Clinical trial2017-04-18Results posted · ClinicalTrials.gov

Study to Evaluate the Preference, Satisfaction and Correct Use of Inhalers in Patients With Chronic Obstructive Pulmonary Disease

Clinical trial2017-01-24Results posted · ClinicalTrials.gov

The Effect of Glycopyrronium and Indacaterol, as Monotherapy and in Combination, on the Methacholine Dose-response Curve

Clinical trial2017-01-09Completed · ClinicalTrials.gov

Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation

Clinical trial2016-11-01Completed · ClinicalTrials.gov

Efficacy and Safety of Indacaterol vs Tiotropium From Baseline to 24 Weeks, in Women With Moderate-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial

Clinical trial2016-07-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Indacaterol
RxNorm CUI
1114326
ChEMBL ID
CHEMBL1095777
ATC codes
R03AC18
UNII
8OR09251MQ
Regulatory jurisdictions
ema

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
EMA
Total events
2
emaEuropean Medicines Agency· 2 events
2026-10-30Market withdrawalMarket
EU marketing authorisation withdrawn: Hirobriz Breezhaler (EMA)

Indication: Hirobriz Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Evidence ↗
2026-10-30Market withdrawalMarket
EU marketing authorisation withdrawn: Oslif Breezhaler (EMA)

Indication: Oslif Breezhaler is indicated for maintenance bronchodilator treatment of airflow obstruction in adult patients with chronic obstructive pulmonary disease.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

62 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
62
registered trials across all phases
LATEST COMPLETION 2021
46
Late-stage (III+)
58
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 62
Phase 13Phase 1 / 21Phase 212Phase 2 / 31Phase 329Phase 415Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD

CompletedPH IVCentre Hospitalier Universitaire de Besanconn=422021

The Effect of Glycopyrronium and Indacaterol, as Monotherapy and in Combination, on the Methacholine Dose-response Curve

CompletedPH IVUniversity of Saskatchewann=312017

Efficacy and Safety of Indacaterol vs Tiotropium From Baseline to 24 Weeks, in Women With Moderate-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial

CompletedPH IVNational Institute of Respiratory Diseases, Mexicon=732016

Proof of Concept Study to Evaluate Single and Chronic Dosing Effects of Ultra-long Acting Bronchodilator Therapy on Mannitol Challenge in Asthmatic Patients Taking Inhaled Corticosteroids

CompletedPH IVUniversity of Dundeen=142016

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

CompletedPH IVNovartis Pharmaceuticalsn=242016

Recent completions

Trials that read out recently, adding to the completed evidence base.

Effects of Long Acting Bronchodilators on CARDiac Autonomic Nervous System Control in Patients With COPD

CompletedPH IVCentre Hospitalier Universitaire de Besanconn=422021

The Effect of Glycopyrronium and Indacaterol, as Monotherapy and in Combination, on the Methacholine Dose-response Curve

CompletedPH IVUniversity of Saskatchewann=312017

Indacaterol in Heart Failure Patients: Any Role on Lung Fluid Regulation

CompletedPH IIICentro Cardiologico Monzinon=442016

Efficacy and Safety of Indacaterol vs Tiotropium From Baseline to 24 Weeks, in Women With Moderate-severe COPD Secondary to Biomass Exposure: Randomized, Non Inferior, Open Label, Parallel Groups Clinical Trial

CompletedPH IVNational Institute of Respiratory Diseases, Mexicon=732016

Proof of Concept Study to Evaluate Single and Chronic Dosing Effects of Ultra-long Acting Bronchodilator Therapy on Mannitol Challenge in Asthmatic Patients Taking Inhaled Corticosteroids

CompletedPH IVUniversity of Dundeen=142016

Effects of Indacaterol in Symptomatic COPD Patients With Low Risk of Exacerbations

CompletedPH IVNovartis Pharmaceuticalsn=242016
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.