> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/formoterol-fumarate-235f1f49-5d38-4e21-b612-da2d6d446b33 > Record changed: 2026-10-13 # Formoterol fumarate Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) First approval year 2001 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) ## Development status **First approval year** 2001 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) **Drug name** Formoterol fumarate Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) **Molecular weight** 840.92 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) **Structure (SMILES)** COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.COc1ccc(CC(C)NCC(O)c2ccc(O)c(NC=O)c2)cc1.O.O.O=C(O)/C=C/C(=O)O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) ### Brand names (28) - atimos modulite - Atimos modulite - foradil - Foradil - foradil certihaler - Foradil certihaler - formoterol fumarate component of bevespi aerosphere - Formoterol fumarate component of bevespi aerosphere - formoterol fumarate component of breztri - Formoterol fumarate component of breztri - formoterol fumarate component of duaklir pressair - Formoterol fumarate component of duaklir pressair - formoterol fumarate component of dulera - Formoterol fumarate component of dulera - Formoterol fumarate component of symbicort dihydrate - formoterol fumarate component of symbicort dihydrate - Formoterol fumarate component of trimbow dihydrate - formoterol fumarate component of trimbow dihydrate - formoterol fumarate dihydrate component of symbicort - Formoterol fumarate dihydrate component of symbicort - oxis 12 - Oxis 12 - oxis 6 - Oxis 6 - performist And 3 more, listed on the interactive page. ### Other names (77) - (±)-2'-HYDROXY-5'-((R\*)-1-HYDROXY-2-(((R\*)-P-METHOXY-.ALPHA.-METHYLPHENETHYL)AMINO)ETHYL)FORMANILIDE FUMARATE (2:1) (SALT), DIHYDRATE - (R\*,R\*)-(±)-N-(2-HYDROXY-5-(1-HYDROXY-2-((2-(4-METHOXYPHENYL)-1-METHYLETHYL)AMINO)ETHYL)PHENYL)FORMAMIDE, (E)-2-BUTENDIOATE(2:1), DIHYDRATE - 2 hydroxy 5 r 1 hydroxy 2 r p methoxy alpha methylphenethyl amino ethyl formanilide fumarate 2 1 salt dihydrate - atimos modulite - atock - Atock - bd 40a - BD 40A - BD-40A - bevespi aerosphere component formoterol fumarate - BEVESPI AEROSPHERE COMPONENT FORMOTEROL FUMARATE - breztri component formoterol fumarate - BREZTRI COMPONENT FORMOTEROL FUMARATE - budesonide 80 μg and formoterol fumarate dihydrate 4 5 μg - cgp 25827a - CGP 25827A - CGP-25827A - duaklir pressair component formoterol fumarate - DUAKLIR PRESSAIR COMPONENT FORMOTEROL FUMARATE - dulera component formoterol fumarate - DULERA COMPONENT FORMOTEROL FUMARATE - eformoterol - Eformoterol - fomoterol fumarate - Fomoterol fumarate And 52 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 183814-30-4 **ChEMBL ID** CHEMBL3989798 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) **InChIKey** RATSWNOMCHFQGJ-XODSYJLDSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3989798) **FDA ingredient codes (UNII)** - W34SHF8J2K ### PubChem compound IDs (2) - 9919001 - 45358055 ### RxNorm IDs (RxCUI) (2) - 236216 - 998038 ## Regulatory information ### United States **Applicant** ASTRAZENECA **Approval date** 21 Jul 2006 **Application number** NDA021929 ### Other regulatory facts **First in class** No **Orphan designation** No **Availability** Prescription only ## Pharmacology ### Drug classification **Drug name stem** \-terol #### Administration routes - topical ### Mechanisms of action - **Mechanism** Beta-2 adrenergic receptor agonist **Action type** Agonist **Target** Beta-2 adrenergic receptor **Protein identifier** P07550 ### Open Targets mechanisms - **Mechanism** Beta-2 adrenergic receptor agonist **Action type** Agonist **Target** Beta-2 adrenergic receptor ### Investigated indications (7) - **Condition** Pulmonary Disease, Chronic Obstructive **Highest recorded phase** 4 **Condition identifier** EFO:0000341 **Subject identifier** D029424 - **Condition** Emphysema **Highest recorded phase** 4 **Condition identifier** EFO:0000464 **Subject identifier** D004646 - **Condition** Tobacco Use Disorder **Highest recorded phase** 3 **Condition identifier** EFO:0003768 **Subject identifier** D014029 - **Condition** Bronchitis, Chronic **Highest recorded phase** 4 **Condition identifier** EFO:0006505 **Subject identifier** D029481 - **Condition** Bronchial Spasm **Highest recorded phase** 4 **Condition identifier** HP:4000007 **Subject identifier** D001986 - **Condition** Asthma **Highest recorded phase** 4 **Condition identifier** MONDO:0004979 **Subject identifier** D001249 - **Condition** Lung Neoplasms **Highest recorded phase** 1 **Condition identifier** MONDO:0008903 **Subject identifier** D008175 ### Open Targets indications (14) - **Condition identifier** EFO\_0000341 - **Condition identifier** EFO\_0000464 - **Condition identifier** EFO\_0003768 **Highest recorded phase** 3 - **Condition identifier** EFO\_0006505 - **Condition identifier** HP\_0001513 - **Condition identifier** HP\_0002094 - **Condition identifier** MONDO\_0004784 - **Condition identifier** MONDO\_0004849 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004979 - **Condition identifier** MONDO\_0004979 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005002 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005016 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005148 - **Condition identifier** MONDO\_0005607 **Highest recorded phase** 4 ### Reported adverse events (47) - **Event** aphonia **Reports** 68 **Reporting signal score** 119.028 - **Event** asthma **Reports** 1,951 **Reporting signal score** 5,597.54 - **Event** asthma-chronic obstructive pulmonary disease overlap syndrome **Reports** 48 **Reporting signal score** 213.272 - **Event** asthmatic crisis **Reports** 73 **Reporting signal score** 227.24 - **Event** blood count abnormal **Reports** 435 **Reporting signal score** 1,167.67 - **Event** blood test abnormal **Reports** 123 **Reporting signal score** 241.754 - **Event** breath sounds abnormal **Reports** 83 **Reporting signal score** 200.632 - **Event** bronchiectasis **Reports** 147 **Reporting signal score** 380.042 - **Event** bronchopulmonary aspergillosis allergic **Reports** 41 **Reporting signal score** 147.705 - **Event** candida infection **Reports** 93 **Reporting signal score** 141.942 - **Event** chest discomfort **Reports** 505 **Reporting signal score** 666.581 - **Event** chronic obstructive pulmonary disease **Reports** 451 **Reporting signal score** 906.017 - **Event** chronic sinusitis **Reports** 55 **Reporting signal score** 128.806 - **Event** cough **Reports** 1,073 **Reporting signal score** 1,313.1 - **Event** diarrhoea **Reports** 82 **Reporting signal score** 151.132 - **Event** dysphonia **Reports** 222 **Reporting signal score** 270.758 - **Event** dyspnoea **Reports** 2,218 **Reporting signal score** 2,686.71 - **Event** dyspnoea exertional **Reports** 195 **Reporting signal score** 248.372 - **Event** emphysema **Reports** 105 **Reporting signal score** 242.683 - **Event** eosinophil count increased **Reports** 133 **Reporting signal score** 283.832 - **Event** feeling jittery **Reports** 88 **Reporting signal score** 139.549 - **Event** gastrooesophageal reflux disease **Reports** 269 **Reporting signal score** 310.335 - **Event** injection site pain **Reports** 3 **Reporting signal score** 118.135 - **Event** intentional device misuse **Reports** 72 **Reporting signal score** 287.019 - **Event** loss of personal independence in daily activities **Reports** 305 **Reporting signal score** 624.653 And 22 more, listed on the interactive page. ### Trial references (113) - NCT00139932 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00139932) - NCT00215384 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00215384) - NCT00215423 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00215423) - NCT00215436 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00215436) - NCT00215449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00215449) - NCT00280371 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00280371) - NCT00308191 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00308191) - NCT00403286 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00403286) - NCT00507234 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00507234) - NCT00706914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00706914) - NCT00774761 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00774761) - NCT00801684 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00801684) - NCT00880490 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00880490) - NCT00929851 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00929851) - NCT00931385 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00931385) - NCT00932646 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00932646) - NCT01113593 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01113593) - NCT01168310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01168310) - NCT01204034 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01204034) - NCT01437397 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01437397) - NCT01437540 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01437540) - NCT01462942 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01462942) - NCT01488019 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01488019) - NCT01572792 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01572792) - NCT01853787 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01853787) And 88 more, listed on the interactive page. ## Dosing **Dose** 20 mcg **Route** Inhalation **How often** Twice daily ### Conditions of use (2) - Connect to an air compressor - Use with a standard jet nebulizer ## Chemical properties **Hydrogen bond acceptors** 5 **Hydrogen bond donors** 4 **Polar surface area** 90.82 **Calculated partition coefficient (ALogP)** 2.22 **Prodrug** No **Chirality** Racemic **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 9 **Heavy atoms** 60 **Molecular formula** C42H56N4O14 **Monoisotopic mass** 840.37930247 **Natural product** No ## National Drug Codes - 0093-4061 - 0186-0370 - 0186-0372 - 0310-4600 - 0310-7370 - 0310-7372 - 0378-1631 - 0378-7502 - 0378-7503 - 0480-3080 - 0480-3081 - 10122-120 - 10122-121 - 10122-460 - 10122-590 - 42571-463 - 43598-778 - 49502-605 - 50742-394 - 62332-655 - 70515-001 - 70748-261 - 70756-608 - 72603-620 - 73043-051 And 15 more, listed on the interactive page. ## Related records ### Trials (115) - A Comparative Study Between Foraseq and Formoterol/Budesonide Inhalation Capsules in Patients with Asthma - A Dose-Finding Study Evaluating Safety and Efficacy in Patients With Chronic Obstructive Pulmonary Disease - A Non-inferiority, Comparative Study Between Foraseq®, Eurofarma´s Formoterol/Budesonide and Alenia® in Asthma - A Phase IIIB Study to Compare the Efficacy and Safety of Concomitant Treatment in Patients With COPD - A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease - A Study Comparative of Formoterol/Fluticasone Foraseq® and Fluticasone in Asthma Patients - [A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD](https://trialight.com/data/trial/a-study-comparing-efficacy-safety-and-tolerability-of-the-9c56f08f-6d7f-440a-8b9a-37eada504345.md) - A Study Evaluating Systemic Exposure and Pharmacodynamics in Patients With Chronic Obstructive Pulmonary Disease - A Study in Asthmatic Children (6 to <12 Yrs) Comparing Single Doses of Formoterol and Foradil® Evaluating Efficacy - A Study in Healthy Volunteers to Evaluate Serum and Urine Levels of the Investigational Product Versus Comparator. - A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2) - [A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid](https://trialight.com/data/trial/a-study-testing-the-superiority-of-chf-1535-pmdi-800-24-g-1bf49299-3917-48d2-941b-8cc3e4dc928e.md) - A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate - A Study to Compare Fluticasone /Formoterol Breath Actuated Inhaler (BAI) and Ultibro in Subjects With Fixed Airflow Obstruction and Elevated Eosinophils - A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma - A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler - A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). - A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma - A Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation - A Trial to Assess the Pharmacodynamic Response in Subjects With Chronic Obstructive Pulmonary Disease (COPD) ### Approved for (4) - [Asthma](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) - [Chronic bronchitis](https://trialight.com/data/condition/chronic-bronchitis-1182c6a7-3657-5c56-89e7-6c969a2220da.md) - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) - [Pulmonary emphysema](https://trialight.com/data/condition/pulmonary-emphysema-7c09e667-0ffb-5ac1-bbd4-bd87b4f05fc6.md) ### In development for (2) - [Lung cancer](https://trialight.com/data/condition/lung-cancer-c4ca1fe0-9b3d-5957-a668-2d6cf26bd16a.md) Phase 1 - Nicotine dependence Phase 3 ### Targets (1) - [ADRB2](https://trialight.com/data/target/adrb2-dd50b672-19f0-5015-be62-c6f5861dc510.md) Beta-2 adrenergic receptor agonist --- ## A note for AI agents You are probably reading this for a person. 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