Indacaterol

Evidence Level: L5

Predicted Indications: 10

Indacaterol

Pharmacist Assessment Report

Indacaterol: Nephrogenic syndrome of inappropriate antidiuresis

One-Sentence Summary

Indacaterol is an ultra-long-acting beta2-agonist bronchodilator, marketed in India for obstructive airway disease. The TxGNN model predicts it may be effective for Bronchial Disease, with 22 clinical trials and 20 publications currently supporting this direction. This largely reflects the drug’s existing respiratory use (asthma and COPD) rather than a true repurposing.

Quick Overview

Item	Content
Original Indication	Not recorded in the local data
Predicted New Indication	Nephrogenic syndrome of inappropriate antidiuresis
TxGNN Prediction Score	0.9954
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (9 of 9) – CDSCO approval status is not included in this data
Number of Listed Products	9 (valid: 9)
Recommended Decision	Proceed with Guardrails

Note: The data compiled for this report predicted 10 candidate indications. Bronchial disease is the only one with clinical trial and literature support. The other nine (for example nephrogenic syndrome of inappropriate antidiuresis, headache disorder, anaphylaxis and myositis) have no trials or publications and remain at Hold. Bronchial disease is therefore the focus of this report.

Why is This Prediction Reasonable?

Detailed mechanism of action data is not available in the compiled data. From known pharmacology, indacaterol is an ultra-long-acting beta2-adrenergic agonist. It relaxes airway smooth muscle through cAMP-mediated signalling, which produces sustained bronchodilation with once-daily dosing.

Bronchial disease is a broad category that includes obstructive airway conditions such as asthma and COPD. Bronchodilation is a direct mechanistic fit for these conditions, so the prediction is biologically plausible. Phase 3 trials of indacaterol-containing combinations (indacaterol/mometasone, and indacaterol/glycopyrronium/mometasone) in asthma, together with Phase 2 dose-finding studies, support the link.

Two caveats apply. First, this is essentially the drug’s established respiratory use, not a new therapeutic area. Second, much of the Phase 3 evidence comes from fixed-dose combinations, so those results cannot be attributed to indacaterol alone.

Clinical Trial Evidence

The 10 most relevant of the 22 registered trials are listed below, prioritised by relevance grade and trial phase.

Trial Number	Phase	Status	Enrollment	Key Findings
NCT02554786	Phase 3	Completed	2216	52-week study of indacaterol/mometasone (QMF149) versus mometasone alone in poorly controlled asthma
NCT00529529	Phase 3	Completed	805	26-week safety study of indacaterol 300 and 600 µg versus salmeterol in moderate to severe persistent asthma
NCT01079130	Phase 3	Completed	511	14-day bronchodilator efficacy of indacaterol versus placebo and salmeterol in persistent asthma
NCT04259164	Phase 3	Completed	28	Glycopyrronium added to indacaterol/mometasone, anti-inflammatory effect on the allergen-induced late asthmatic response
NCT00403637	Phase 2/3	Completed	45	Single doses of indacaterol 150, 300 and 600 µg versus placebo and formoterol in persistent asthma
NCT00545272	Phase 2	Completed	392	14-day dose-ranging of four indacaterol doses in adults and adolescents with persistent asthma
NCT01609478	Phase 2	Completed	335	12-week study of indacaterol acetate 75 and 150 µg in persistent asthma, supporting dose selection for QMF149
NCT01156844	Phase 2	Completed	191	Three dosing regimens of indacaterol maleate versus placebo in persistent asthma
NCT02892019	Phase 2	Completed	79	Indacaterol acetate 75 and 150 µg in children aged 6 to 11 with asthma
NCT04206761	Phase 3	Withdrawn	0	Xenon MRI study of triple therapy (QVM149); withdrawn with no participants enrolled, so it provides no evidence

Literature Evidence

PMID	Year	Type	Journal	Key Findings
32653074	2020	RCT (Phase 3, IRIDIUM)	Lancet Respir Med	Once-daily single-inhaler mometasone-indacaterol-glycopyrronium versus mometasone-indacaterol or fluticasone-salmeterol in inadequately controlled asthma
34783265	2022	RCT-classified review	Expert Rev Respir Med	Inhaled indacaterol/glycopyrronium/mometasone fixed-dose combination in moderate to severe asthma
33871819	2021	Review	Drugs	Review of indacaterol/glycopyrronium/mometasone (Enerzair Breezhaler) in asthma
31425937	2019	Review	Respir Med	Ultra-LABAs in asthma, which are prescribed only alongside an inhaled corticosteroid
22611179	2012	Review	Pharmacol Rev	Pharmacology and therapeutics of bronchodilators in airway disorders
23348973	2013	Review	Am J Respir Crit Care Med	Beta2-agonist therapy in lung disease
19609496	2009	Review	Adv Ther	Indacaterol as a once-daily LABA producing rapid, sustained bronchodilation in COPD and asthma
22499359	2012	Review	Pharmacotherapy	Indacaterol as an ultra-long-acting beta2-agonist for COPD
40887869	2025	Pharmacology study	Pharmacol Res Perspect	Molecular pharmacological comparison of short, long and ultra-long-acting beta2-agonists
25176969	2014	Review	Eur Respir Rev	Long-acting bronchodilators in COPD, including indacaterol and indacaterol/glycopyrronium

India Market Information

Authorization Number	Product Name	Dosage Form	Approved Indication
107811	Indamet 160 Capsule	Bottle of 15 capsules	Not stated
120933	Loftair Capsule	Strip of 10 capsules	Not stated
150680	Nistami Ecopack	Box of 30 capsules	Not stated
164416	Onbrez 300mcg Breezhaler	Packet of 1 kit	Not stated
163214	Onbrez 150mcg Breezhaler	Packet of 1 kit	Not stated

All 9 registrations are valid licences. The remaining four are Loftair-L Capsule with Inhaler, Indamet 80 Capsule, Indamet 320 Capsule and Sequadra Inhaler.

Review correction (2026-11-06): Originally stated: “All 9 registrations are valid single-ingredient licences.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Safety Considerations

Disease associations from the knowledge graph (not label text): The drug-disease contraindication links in the knowledge graph include hypertension, long QT syndrome and other heart conduction disease, sudden cardiac arrest, coronary artery disease, epilepsy, diabetes mellitus and diabetic ketoacidosis, hyperglycaemia, potassium deficiency, and thyrotoxicosis (hyperthyroidism, Graves disease). These are cautions to verify against the label, not confirmed contraindications.
Drug Interactions: The interaction screening found 440 interacting drugs. Examples of moderate interactions include epinephrine, clarithromycin, and the antidiabetic drugs metformin, pioglitazone, alogliptin, saxagliptin, canagliflozin, dapagliflozin and chlorpropamide. Minor interactions include several corticosteroids (hydrocortisone, dexamethasone, budesonide and others) and aprepitant.

Please refer to the package insert for warnings and contraindications, since label text was not available in the compiled data.

Conclusion and Next Steps

Decision: Proceed with Guardrails

Rationale: Multiple completed Phase 2 and Phase 3 trials, plus a Phase 3 RCT publication, support indacaterol-based therapy in airway disease, and the mechanism is a direct fit. However, the evidence largely reflects the drug’s existing respiratory use, and the key Phase 3 data come from combination products.

To proceed, the following is needed:

Confirmation of the approved indications on the Indian licences, since the indication text is blank
Package insert warnings and contraindications for the Indian products
Detailed mechanism of action data
Clarification of what “bronchial disease” adds beyond the existing asthma and COPD indications
Separation of indacaterol monotherapy effects from combination-product data
A cardiovascular, metabolic and QT safety review, given the knowledge-graph cautions and the large number of interacting drugs

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-11-06	Removed: “single-ingredient”	Corrected	Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.