{"id":"indacaterol","rwe":[{"pmid":"41771307","year":"2026","title":"Optimizing spray-dried liposomes for pulmonary delivery: impact of lipids composition and of drying parameters using experimental design.","finding":"","journal":"European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V","studyType":"Clinical Study"},{"pmid":"41625872","year":"2025","title":"An Open-Label, Single-Arm, Multicentric, Prospective, Phase IV Study to Evaluate the Safety and Effectiveness of Indacaterol/Mometasone/Glycopyrronium Dry Powder Inhaler (DPI) in the Management of Asthma Patients (OASIS Study).","finding":"","journal":"Cureus","studyType":"Clinical Study"},{"pmid":"41402044","year":"2025","title":"Disproportionate increase in COPD exacerbation risk for 3 months after discontinuing LAMA or ICS: insights from the FLAME trial.","finding":"","journal":"Thorax","studyType":"Clinical 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Prevention with COPD","category":"indication"},{"label":"Prevention of Bronchospasm with Chronic Bronchitis","category":"indication"},{"label":"Prevention of Bronchospasms with Emphysema","category":"indication"},{"label":"Novartis","category":"company"},{"label":"Approved 2010s","category":"decade"}],"phase":"marketed","safety":{"safetySignals":[{"llr":198.163,"date":"","count":43,"signal":"Bacterial disease carrier","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=198)"},{"llr":177.167,"date":"","count":306,"signal":"Dyspnoea","source":"DrugCentral FAERS","actionTaken":"Reported 306 times (LLR=177)"},{"llr":169.656,"date":"","count":31,"signal":"Hyper IgE syndrome","source":"DrugCentral FAERS","actionTaken":"Reported 31 times (LLR=170)"},{"llr":161.183,"date":"","count":43,"signal":"Bronchial secretion retention","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=161)"},{"llr":157.188,"date":"","count":43,"signal":"Superinfection","source":"DrugCentral FAERS","actionTaken":"Reported 43 times (LLR=157)"},{"llr":145.296,"date":"","count":62,"signal":"Bronchospasm","source":"DrugCentral FAERS","actionTaken":"Reported 62 times (LLR=145)"},{"llr":144.876,"date":"","count":56,"signal":"Sleep disorder due to a general medical condition","source":"DrugCentral FAERS","actionTaken":"Reported 56 times (LLR=145)"},{"llr":131.441,"date":"","count":110,"signal":"Asthma","source":"DrugCentral FAERS","actionTaken":"Reported 110 times (LLR=131)"},{"llr":127.676,"date":"","count":33,"signal":"Restrictive pulmonary disease","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=128)"},{"llr":116.936,"date":"","count":33,"signal":"Polycystic ovaries","source":"DrugCentral FAERS","actionTaken":"Reported 33 times (LLR=117)"},{"llr":113.734,"date":"","count":93,"signal":"Wheezing","source":"DrugCentral FAERS","actionTaken":"Reported 93 times (LLR=114)"},{"llr":106.399,"date":"","count":38,"signal":"Scoliosis","source":"DrugCentral FAERS","actionTaken":"Reported 38 times (LLR=106)"},{"llr":101.44,"date":"","count":78,"signal":"Chronic obstructive pulmonary disease","source":"DrugCentral FAERS","actionTaken":"Reported 78 times (LLR=101)"},{"llr":100.021,"date":"","count":52,"signal":"Obstructive airways disorder","source":"DrugCentral FAERS","actionTaken":"Reported 52 times (LLR=100)"},{"llr":98.095,"date":"","count":27,"signal":"Sinus operation","source":"DrugCentral FAERS","actionTaken":"Reported 27 times (LLR=98)"}],"drugInteractions":[{"url":"/drug/high-risk-qt-prolonging-agents","drug":"High Risk QT Prolonging Agents","action":"Avoid combination","effect":"Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents","source":"DrugCentral","drugSlug":"high-risk-qt-prolonging-agents"}],"commonSideEffects":[],"contraindications":["Acutely Deteriorating Chronic Obstructive Pulmonary Disease","Chronic myocardial ischemia","Conduction disorder of the heart","Congenital long QT syndrome","Diabetes mellitus","Exacerbation of asthma","Hyperglycemia","Hypertensive disorder","Hypokalemia","Prolonged QT interval","Seizure disorder","Thyrotoxicosis"]},"trials":[],"aliases":[],"company":"Novartis","patents":[{"applNo":"N022383","source":"FDA Orange Book","status":"Active","expires":"Oct 11, 2028","useCode":"","territory":"US","drugProduct":true,"patentNumber":"8479730","drugSubstance":false}],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=INDACATEROL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T01:11:28.153747+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T01:11:28.153629+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Indacaterol","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T01:11:35.063108+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T01:11:33.802322+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-20T01:11:28.222465+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=INDACATEROL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T01:11:34.010816+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1095777/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T01:11:34.701541+00:00"}},"allNames":"arcapta neohaler","offLabel":[],"synonyms":["QAB149","QAB-149","QAB 149","indacaterol","Arcapta Neohaler","indacaterol maleate"],"timeline":[{"date":"2009-11-29","type":"positive","source":"DrugCentral","milestone":"EMA approval (Novartis Europharm Limited)"},{"date":"2011-01-01","type":"neutral","source":"FDA Orange Book","milestone":"Rights transferred from NOVARTIS to Novartis"},{"date":"2011-07-01","type":"positive","source":"DrugCentral","milestone":"FDA approval (Novartis)"},{"date":"2020-06-29","type":"positive","source":"DrugCentral","milestone":"PMDA approval (Novartis Pharma K.K.)"}],"aiSummary":"Arcapta Neohaler (Indacaterol) is a small molecule beta2-adrenergic agonist developed by Novartis, targeting the beta-2 adrenergic receptor to treat asthma, bronchospasm prevention in COPD, chronic bronchitis, and emphysema. It was FDA-approved in 2011 and remains a branded product under Novartis ownership. Key safety considerations include its long half-life of 92.5 hours and moderate bioavailability of 43%. As of now, there are no generic manufacturers available. The commercial status of Arcapta Neohaler is patented.","approvals":[{"date":"2009-11-29","orphan":false,"company":"Novartis Europharm Limited","regulator":"EMA"},{"date":"2011-07-01","orphan":false,"company":"NOVARTIS","regulator":"FDA"},{"date":"2020-06-29","orphan":false,"company":"Novartis Pharma K.K.","regulator":"PMDA"}],"brandName":"Arcapta Neohaler","ecosystem":[{"indication":"Asthma","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"bitolterol","slug":"bitolterol","company":"Sanofi Aventis Us"}],"globalPrevalence":262000000},{"indication":"Bronchospasm Prevention with COPD","otherDrugs":[{"name":"fluticasone propionate","slug":"fluticasone-propionate","company":"Fougera Pharms"},{"name":"formoterol","slug":"formoterol","company":"Novartis"},{"name":"salmeterol","slug":"salmeterol","company":""},{"name":"tiotropium bromide","slug":"tiotropium-bromide","company":"Boehringer Ingelheim"}],"globalPrevalence":null},{"indication":"Prevention of Bronchospasm with Chronic Bronchitis","otherDrugs":[],"globalPrevalence":null},{"indication":"Prevention of Bronchospasms with Emphysema","otherDrugs":[],"globalPrevalence":null}],"mechanism":{"target":"Beta-2 adrenergic receptor","novelty":"Follow-on","targets":[{"gene":"ADRB2","source":"DrugCentral","target":"Beta-2 adrenergic receptor","protein":"Beta-2 adrenergic receptor"},{"gene":"ADRB1","source":"DrugCentral","target":"Beta-1 adrenergic receptor","protein":"Beta-1 adrenergic receptor"},{"gene":"DRD3","source":"DrugCentral","target":"D(3) dopamine receptor","protein":"D(3) dopamine receptor"},{"gene":"DRD2","source":"DrugCentral","target":"D(2) dopamine receptor","protein":"D(2) dopamine receptor"},{"gene":"CYP1B1","source":"DrugCentral","target":"Cytochrome P450 1B1","protein":"Cytochrome P450 1B1"}],"moaClass":"Adrenergic beta2-Agonists","modality":"Small Molecule","drugClass":"beta2-Adrenergic Agonist","explanation":"","oneSentence":"","technicalDetail":"Arcapta Neohaler acts as a selective agonist at the beta-2 adrenergic receptor, activating G-protein coupled signaling pathways that lead to increased intracellular cyclic AMP levels, resulting in bronchodilation and improved lung function."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Indacaterol","title":"Indacaterol","extract":"Indacaterol is an ultra-long-acting beta-adrenoceptor agonist developed by Novartis. It needs to be taken only once a day, unlike the related drugs formoterol and salmeterol. It is licensed only for the treatment of chronic obstructive pulmonary disease (COPD). It is delivered through a dry powder inhaler.","wiki_history":"==History==\nIt was approved by the European Medicines Agency (EMA) under the brand name Onbrez Breezhaler on November 30, 2009, and by the United States Food and Drug Administration (FDA), under the brand name Arcapta Neohaler, on July 1, 2011. In 2016, Novartis licensed its U.S. commercial rights for Arcapta Neohaler to Sunovion Pharmaceuticals."},"commercial":{"launchDate":"2011","_launchSource":"DrugCentral (FDA 2011-07-01, NOVARTIS)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/4183","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=INDACATEROL","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=INDACATEROL","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Indacaterol","fields":["history","overview"],"source":"Wikipedia"},{"id":5,"url":"https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files","fields":["patents","exclusivity","genericManufacturers"],"source":"FDA Orange 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— generic available","relationship":"same-class"},{"drugName":"clenbuterol","drugSlug":"clenbuterol","fdaApproval":"","relationship":"same-class"},{"drugName":"bitolterol","drugSlug":"bitolterol","fdaApproval":"1984-12-28","patentStatus":"Unknown","relationship":"same-class"},{"drugName":"olodaterol","drugSlug":"olodaterol","fdaApproval":"2014-07-31","patentExpiry":"Jan 19, 2027","patentStatus":"Patent protected","relationship":"same-class"}],"genericName":"indacaterol","indications":{"approved":[{"name":"Asthma","source":"DrugCentral","snomedId":195967001,"regulator":"FDA","usPrevalence":25000000,"globalPrevalence":262000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2023"},{"name":"Bronchospasm Prevention with COPD","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Prevention of Bronchospasm with Chronic Bronchitis","source":"DrugCentral","snomedId":"","regulator":"FDA"},{"name":"Prevention of Bronchospasms with Emphysema","source":"DrugCentral","snomedId":"","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"currentOwner":"Novartis","drugCategory":"loe-approaching","labelChanges":[],"relatedDrugs":[{"drugId":"salbutamol","brandName":"salbutamol","genericName":"salbutamol","approvalYear":"1981","relationship":"same-class"},{"drugId":"terbutaline","brandName":"terbutaline","genericName":"terbutaline","approvalYear":"1974","relationship":"same-class"},{"drugId":"isoetarine","brandName":"isoetarine","genericName":"isoetarine","approvalYear":"1979","relationship":"same-class"},{"drugId":"pirbuterol","brandName":"pirbuterol","genericName":"pirbuterol","approvalYear":"1986","relationship":"same-class"},{"drugId":"salmeterol","brandName":"salmeterol","genericName":"salmeterol","approvalYear":"1994","relationship":"same-class"},{"drugId":"formoterol","brandName":"formoterol","genericName":"formoterol","approvalYear":"2001","relationship":"same-class"},{"drugId":"clenbuterol","brandName":"clenbuterol","genericName":"clenbuterol","approvalYear":"","relationship":"same-class"},{"drugId":"bitolterol","brandName":"bitolterol","genericName":"bitolterol","approvalYear":"1984","relationship":"same-class"},{"drugId":"olodaterol","brandName":"olodaterol","genericName":"olodaterol","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT05562466","phase":"PHASE3","title":"A 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Glycopyrronium","status":"COMPLETED","sponsor":"University Medical Center Groningen","startDate":"2020-09-10","conditions":["Asthma","Allergic Asthma"],"enrollment":28,"completionDate":"2022-12-29"},{"nctId":"NCT03662711","phase":"PHASE4","title":"Inhaled Long-acting Bronchodilators With or Without Inhaled Glucocorticosteroids for Preventing Hospitalizations and Death in Elderly Patients With Chronic Obstructive Pulmonary Disease","status":"TERMINATED","sponsor":"Università degli Studi di Ferrara","startDate":"2018-11-11","conditions":["Pulmonary Disease, Chronic Obstructive"],"enrollment":843,"completionDate":"2022-10-26"},{"nctId":"NCT05288075","phase":"PHASE1","title":"Study to Compare Relative Bioavailability of 3 Indacaterol/Glycopyrronium Test Products and Reference Product","status":"COMPLETED","sponsor":"Orion Corporation, Orion Pharma","startDate":"2022-02-28","conditions":["Healthy 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