{"id":"bitolterol","rwe":[],"tags":[{"label":"bitolterol","category":"class"},{"label":"Small Molecule","category":"modality"},{"label":"Beta-2 adrenergic receptor","category":"target"},{"label":"ADRB2","category":"gene"},{"label":"R03AC17","category":"atc"},{"label":"Off-Patent","category":"patent"},{"label":"Active","category":"status"},{"label":"Acute exacerbation of asthma","category":"indication"},{"label":"Asthma","category":"indication"},{"label":"Asthma management","category":"indication"},{"label":"Bronchiectasis","category":"indication"},{"label":"Bronchitis","category":"indication"},{"label":"Bronchospasm Prevention","category":"indication"},{"label":"Sanofi Aventis Us","category":"company"},{"label":"Approved 1980s","category":"decade"},{"label":"Adrenergic Agents","category":"pharmacology"},{"label":"Adrenergic Agonists","category":"pharmacology"},{"label":"Adrenergic beta-2 Receptor Agonists","category":"pharmacology"},{"label":"Adrenergic beta-Agonists","category":"pharmacology"},{"label":"Anti-Asthmatic Agents","category":"pharmacology"},{"label":"Bronchodilator Agents","category":"pharmacology"},{"label":"Neurotransmitter Agents","category":"pharmacology"},{"label":"Peripheral Nervous System Agents","category":"pharmacology"},{"label":"Respiratory System Agents","category":"pharmacology"}],"phase":"marketed","safety":{},"trials":[],"aliases":[],"company":"Sanofi","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=BITOLTEROL","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-20T03:48:40.979654+00:00"},"timeline":{"url":"https://en.wikipedia.org/wiki/Bitolterol","method":"deterministic","source":"Wikipedia","rawText":"","confidence":0.8,"sourceType":"wikipedia","retrievedAt":"2026-04-20T03:48:54.533316+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-20T03:48:52.836845+00:00"},"publicationCount":{"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BITOLTEROL","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T03:48:53.942606+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL1201295/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T03:48:54.413913+00:00"}},"allNames":"tornalate","offLabel":[],"synonyms":["bitolterol methanesulfonate","tornalate","bitolterol mesylate","bitolterol","bitolterol mesilate"],"timeline":[{"date":"1984-12-28","type":"positive","source":"DrugCentral","milestone":"FDA approval (Sanofi Aventis Us)"},{"date":"1992-02-19","type":"positive","source":"FDA Orange Book","milestone":"Tornalate approved — 0.2%"}],"aiSummary":"Tornalate (bitolterol) is a small molecule drug developed by Sanofi Aventis US that targets the beta-2 adrenergic receptor. It was approved by the FDA in 1984 for various respiratory indications, including asthma, bronchitis, and pulmonary emphysema. Despite being off-patent, there are currently no generic manufacturers of the drug. Tornalate is used to prevent bronchospasm and manage symptoms of respiratory diseases. Its commercial status and pharmacokinetic properties are not well-documented.","brandName":"Tornalate","ecosystem":[{"indication":"Acute exacerbation of asthma","otherDrugs":[{"name":"epinephrine","slug":"epinephrine","company":""},{"name":"levosalbutamol","slug":"levosalbutamol","company":"Oak Pharms Inc"},{"name":"norepinephrine","slug":"norepinephrine","company":"Hospira"},{"name":"orciprenaline","slug":"orciprenaline","company":""}],"globalPrevalence":262000000},{"indication":"Asthma","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"betamethasone","slug":"betamethasone","company":""},{"name":"betamethasone acetate","slug":"betamethasone-acetate","company":""},{"name":"budesonide","slug":"budesonide","company":""}],"globalPrevalence":262000000},{"indication":"Asthma management","otherDrugs":[{"name":"beclometasone dipropionate","slug":"beclometasone-dipropionate","company":""},{"name":"budesonide","slug":"budesonide","company":""},{"name":"ciclesonide","slug":"ciclesonide","company":"Takeda Gmbh"},{"name":"cromoglicic acid","slug":"cromoglicic-acid","company":"King Pharms"}],"globalPrevalence":262000000},{"indication":"Bronchiectasis","otherDrugs":[{"name":"acetylcysteine","slug":"acetylcysteine","company":"Apothecon"},{"name":"cysteine","slug":"cysteine","company":"Hospira"},{"name":"epinephrine","slug":"epinephrine","company":""},{"name":"norepinephrine","slug":"norepinephrine","company":"Hospira"}],"globalPrevalence":null},{"indication":"Bronchitis","otherDrugs":[{"name":"acetylcysteine","slug":"acetylcysteine","company":"Apothecon"},{"name":"amphotericin B","slug":"amphotericin-b","company":"Apothecon"},{"name":"cefixime","slug":"cefixime","company":""},{"name":"cefprozil","slug":"cefprozil","company":""}],"globalPrevalence":null},{"indication":"Bronchospasm Prevention","otherDrugs":[{"name":"cromoglicic acid","slug":"cromoglicic-acid","company":"King Pharms"},{"name":"levosalbutamol","slug":"levosalbutamol","company":"Oak Pharms Inc"},{"name":"orciprenaline","slug":"orciprenaline","company":""},{"name":"pirbuterol","slug":"pirbuterol","company":""}],"globalPrevalence":null},{"indication":"Pulmonary emphysema","otherDrugs":[{"name":"arformoterol","slug":"arformoterol","company":"Sunovion"},{"name":"diprophylline","slug":"diprophylline","company":""},{"name":"epinephrine","slug":"epinephrine","company":""},{"name":"fluticasone furoate","slug":"fluticasone-furoate","company":"Glaxosmithkline"}],"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"}],"modality":"Small Molecule","drugClass":"bitolterol","explanation":"","oneSentence":"","technicalDetail":"Tornalate is a selective beta-2 adrenergic receptor agonist that stimulates the receptor, leading to increased intracellular cyclic AMP levels and subsequent relaxation of airway smooth muscle."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Bitolterol","title":"Bitolterol","extract":"Bitolterol mesylate, formerly sold under the brand name Tornalate, is a short-acting β2-adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease (COPD). Bitolterol relaxes the smooth muscles present continuously around the bronchi and bronchioles facilitating the flow of air through them."},"commercial":{"launchDate":"1984","_launchSource":"DrugCentral (FDA 1984-12-28, SANOFI AVENTIS US)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/384","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=BITOLTEROL","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://en.wikipedia.org/wiki/Bitolterol","fields":["history","overview"],"source":"Wikipedia"},{"id":4,"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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