Indacaterol Maleate Clinical Trials

Size	Price	Qty
5mg	USD 270
1g	USD 3,990

Clinical Trials

Numerous clinical trials evaluate indacaterol across Phase 1 through Phase 4 development, primarily targeting chronic obstructive pulmonary disease (COPD), asthma, general obstructive lung diseases, and healthy volunteer cohorts. Sponsored by academic investigators and major pharmaceutical companies—including Novartis, AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, and Orion Pharma—these studies span various operational statuses, from actively recruiting and completed to terminated, withdrawn, or suspended.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05776927	RECRUITING	Asthma	Novartis Pharmaceuticals	2026-08-04	PHASE3
NCT05562466	RECRUITING	Asthma	Novartis Pharmaceuticals	2023-05-11	PHASE3
NCT06067100	RECRUITING	Exercise Performance	Morten Hostrup, PhD	2024-01-15
NCT06077019	RECRUITING	Exercise Performance	Morten Hostrup, PhD	2023-10-03
NCT06035393	TERMINATED	Chronic Obstructive Pulmonary Disease	Jiangsu HengRui Medicine Co., Ltd.	2024-01-15	PHASE2
NCT07541378	SUSPENDED	COPD (Chronic Obstructive Pulmonary Disease)	Medical University of Bialystok	2024-03-11
NCT04259164	COMPLETED	Asthma; Allergic Asthma	University Medical Center Groningen	2020-09-10	PHASE3
NCT05288075	COMPLETED	Healthy Volunteers	Orion Corporation, Orion Pharma	2022-02-28	PHASE1
NCT04589663	COMPLETED	Asthma	Novartis Pharmaceuticals	2021-06-07	PHASE2
NCT05288075	Completed	Healthy Volunteers	Orion Corporation Orion Pharma	2022-02-28	Phase 1
NCT04856098	COMPLETED	Healthy Volunteers	Orion Corporation, Orion Pharma	2021-05-07	PHASE1
NCT02867761	COMPLETED	COPD (Chronic Obstructive Pulmonary Disease)	University of Michigan	2017-08-29	PHASE3
NCT02872090	COMPLETED	Chronic Obstructive Pulmonary Disease	Centre Hospitalier Universitaire de Besancon	2016-03	PHASE4
NCT02892019	COMPLETED	Asthma	Novartis Pharmaceuticals	2017-04-18	PHASE2
NCT02567214	COMPLETED	COPD	Laval University	2016-06	PHASE4
NCT02554786	COMPLETED	Asthma	Novartis Pharmaceuticals	2015-12-29	PHASE3
NCT02566031	COMPLETED	COPD	Novartis Pharmaceuticals	2013-03-23	PHASE4
NCT03364829	UNKNOWN	Chronic Obstructive Pulmonary Disease	Taipei Medical University Shuang Ho Hospital	2016-01-01	PHASE4
NCT03257995	COMPLETED	Asthma	Novartis Pharmaceuticals	2017-09-05	PHASE2
NCT02576626	COMPLETED	COPD	Wouter H. van Geffen	2015-12	PHASE4
NCT02516592	COMPLETED	COPD	Novartis Pharmaceuticals	2015-10-13	PHASE4
NCT02442206	COMPLETED	Chronic Obstructive Pulmonary Disease, COPD	Novartis Pharmaceuticals	2015-05-18	PHASE4
NCT02202616	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2014-08-27	PHASE4
NCT03030638	Completed	Pulmonary Disease Chronic Obstructive	Boehringer Ingelheim\|RTI health solutions US	2017-02-08	--
NCT02953041	COMPLETED	Asthma	University of Saskatchewan	2016-10	PHASE4
NCT02598505	COMPLETED	Heart Failure	Centro Cardiologico Monzino	2015-09	PHASE3
NCT02693769	TERMINATED	ACOS (Fixed Airflow Obstruction and Elevated Eosinophils)	Mundipharma Research Limited	2016-07	PHASE2; PHASE3
NCT02487446	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2015-07-28	PHASE3
NCT02487498	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2015-07-27	PHASE3
NCT02573155	COMPLETED	Asthma (Part 1); COPD (Part 2)	AstraZeneca	2015-10	PHASE1
NCT02665130	COMPLETED	Chronic Obstructive Pulmonary Disease	Yuan-Ming Luo	2014-12	PHASE4
NCT02039011	COMPLETED	Asthma	University of Dundee	2014-02	PHASE4
NCT02233543	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2014-11-30	PHASE4
NCT01985334	COMPLETED	COPD	Novartis Pharmaceuticals	2014-02-14	PHASE4
NCT02418468	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2015-04-28	PHASE4
NCT02055352	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2014-05-30	PHASE4
NCT05506865	COMPLETED	COPD	National Institute of Respiratory Diseases, Mexico	2012-09	PHASE4
NCT01727024	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2013-04	PHASE4
NCT02547558	UNKNOWN	Chronic Obstructive Pulmonary Disease	Hospital Clinic of Barcelona	2015-10	PHASE4
NCT01782326	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2013-07	PHASE3
NCT02473237	COMPLETED	COPD	National Institute of Respiratory Diseases, Mexico	2013-04	PHASE4
NCT01794780	COMPLETED	COPD	Novartis Pharmaceuticals	2013-02-05	PHASE4
NCT02257385	COMPLETED	Pulmonary Disease, Chronic Obstructive	GlaxoSmithKline	2014-10-15	PHASE3
NCT02059434	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD); Asthma	AstraZeneca	2013-09-01	PHASE1
NCT01996124	COMPLETED	COPD; Hyperinflation; Right Cardiac Failure	University of Milan	2013-11	PHASE4
NCT01437748	COMPLETED	Healthy; COPD	University of Milan	2011-08	PHASE4
NCT01778062	COMPLETED	Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis	Novartis Pharmaceuticals	2013-02	PHASE3
NCT01959412	COMPLETED	Asthma	Novartis Pharmaceuticals	2013-11	PHASE2
NCT01555138	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2012-02	PHASE4
NCT01709903	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2012-11	PHASE3
NCT01712516	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2012-12	PHASE3
NCT01727141	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2012-11	PHASE3
NCT01845623	WITHDRAWN	Asthma	Novartis Pharmaceuticals	2013-08	PHASE2
NCT01693003	COMPLETED	Chronic Obstructive Pulmonary Disease	Irmandade Santa Casa de Misericórdia de Porto Alegre	2013-03	PHASE4
NCT01715311	WITHDRAWN	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2012-11	PHASE4
NCT01609478	COMPLETED	Asthma	Novartis Pharmaceuticals	2012-08	PHASE2
NCT01604278	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2012-05	PHASE3
NCT01498081	COMPLETED	COPD	AstraZeneca	2012-03	PHASE2
NCT01285492	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2011-01	PHASE3
NCT00845728	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2009-03	PHASE3
NCT01232894	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2011-03	PHASE3
NCT01484197	COMPLETED	Asthma	Novartis Pharmaceuticals	2011-11	PHASE2
NCT01272362	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2010-04	PHASE4
NCT01315249	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2011-03	PHASE3
NCT01543828	COMPLETED	COPD	Novartis Pharmaceuticals	2012-01	PHASE4
NCT01377428	WITHDRAWN	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2011-09	PHASE4
NCT01202188	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2010-09	PHASE3
NCT01120717	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2010-04	PHASE3
NCT01294787	COMPLETED	COPD	Novartis Pharmaceuticals	2011-02	PHASE3
NCT01377051	COMPLETED	COPD; Lung Diseases; Dyspnea; Hypoxemia; Tachycardia	University of Milan	2011-05	PHASE4
NCT01012765	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2009-11	PHASE3
NCT00876694	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2009-03	PHASE3
NCT01079130	COMPLETED	Asthma	Novartis Pharmaceuticals	2010-02	PHASE3
NCT01089127	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2010-03	PHASE3
NCT01072448	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2010-01	PHASE3
NCT01156844	COMPLETED	Persistent Asthma	Novartis Pharmaceuticals	2010-03	PHASE2
NCT01068600	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2010-01	PHASE3
NCT00999908	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2009-10	PHASE3
NCT01012739	COMPLETED	Asthma	Novartis Pharmaceuticals	2009-10	PHASE2
NCT00846586	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2009-03	PHASE3
NCT00900731	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2009-06	PHASE3
NCT00792805	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2008-11	PHASE3
NCT00877383	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2009-04	PHASE3
NCT00927901	COMPLETED	Asthma	Novartis Pharmaceuticals	2009-06	PHASE2
NCT00794157	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2008-11	PHASE3
NCT00821093	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2009-01	PHASE3
NCT00677807	COMPLETED	COPD	Novartis	2008-05	PHASE3
NCT00620022	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2008-04	PHASE3
NCT00567996	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis	2007-11	PHASE3
NCT00615459	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis	2008-02	PHASE3
NCT00624702	COMPLETED	Asthma	Novartis	2008-02	PHASE1
NCT00570778	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis Pharmaceuticals	2007-12	PHASE2
NCT00636961	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2008-02	PHASE2
NCT01263808	COMPLETED	Healthy Volunteers; Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2008-04	PHASE1
NCT00669617	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2008-04	PHASE3
NCT00529529	COMPLETED	Asthma	Novartis Pharmaceuticals	2007-09	PHASE3
NCT00463567	COMPLETED	Pulmonary Disease, Chronic Obstructive; COPD; Lung Diseases, Obstructive	Novartis	2007-04	PHASE2; PHASE3
NCT00615030	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis	2008-01	PHASE3
NCT00558285	COMPLETED	Chronic Obstructive Pulmonary Disease (COPD)	Novartis	2007-11	PHASE2
NCT00393458	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2006-10	PHASE3
NCT00622635	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis Pharmaceuticals	2008-01	PHASE3
NCT00624286	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2008-02	PHASE3
NCT00531050	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2007-08	PHASE2
NCT00557466	COMPLETED	COPD	Novartis	2007-10	PHASE2
NCT00545272	COMPLETED	Asthma	Novartis Pharmaceuticals	2007-10	PHASE2
NCT00557440	COMPLETED	Asthma	Novartis	2007-11	PHASE2
NCT00556673	COMPLETED	Asthma	Novartis	2007-10	PHASE2
NCT00605306	COMPLETED	Asthma	Novartis	2008-01	PHASE2
NCT00403754	COMPLETED	Asthma	Novartis Pharmaceuticals	2006-11	PHASE2
NCT00403845	COMPLETED	Chronic Obstructive Pulmonary Disease	Novartis	2006-12	PHASE2
NCT00403637	COMPLETED	Asthma	Novartis	2006-11	PHASE2; PHASE3
NCT00396604	COMPLETED	Pulmonary Disease, Chronic Obstructive; COPD; Lung Diseases, Obstructive	Novartis	2006-10	PHASE2; PHASE3
NCT00410501	COMPLETED	Healthy	Novartis	2006-12	PHASE1
NCT00416702	COMPLETED	Hepatic Insufficiency	Novartis	2006-11	PHASE1
NCT00422552	COMPLETED	COPD	Novartis	2006-09	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-26)

Check the Indacaterol Maleate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Indacaterol functions as a long-acting beta-adrenoceptor agonist that stimulates intracellular adenylate cyclase, elevating cyclic AMP levels and driving the relaxation of bronchial smooth muscle cells. This targeted bronchodilation reduces airway resistance, directly contributing to the management of respiratory obstruction observed in clinical trial conditions such as chronic obstructive pulmonary disease and asthma.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).