Overview
Formoterol is an inhaled beta-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.
Background
Formoterol is an inhaled beta-agonist used in the management of COPD and asthma that was first approved for use in the United States in 2001. It acts on bronchial smooth muscle to dilate and relax airways, and is administered as a racemic mixture of its active (R;R)- and inactive (S;S)-enantiomers. A major clinical advantage of formoterol over other inhaled beta-agonists is its rapid onset of action (2-3 minutes), which is at least as fast as salbutamol, combined with a long duration of action (12 hours) - for this reason, treatment guidelines for asthma recommend its use as both a reliever and maintenance medication. It is available as a single-entity product and in several formulations in combination with both inhaled corticosteroids and long-acting muscarinic antagonists.
Indication
Formoterol is indicated in various formulations for the treatment of asthma and COPD. For the treatment of COPD, formoterol is available as a single-entity inhalation solution, in combination with the long-acting muscarinic antagonists (LAMAs) aclidinium and glycopyrronium, and in combination with the corticosteroid budesonide. For the treatment of asthma, formoterol is available in combination with mometasone furoate for patients 5 years and older and with budesonide for patients 6 years and older. Formoterol may also be used on an as-needed basis for prophylaxis against exercise-induced bronchospasm.
Associated Conditions
- Asthma
- Bronchial Asthma
- Bronchoconstriction
- Chronic Obstructive Pulmonary Disease (COPD)
- Exercise-Induced Bronchospasm
- Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/03/07 | Not Applicable | Not yet recruiting | |||
2024/05/13 | Phase 4 | Recruiting | SamA Pharmaceutical Co., Ltd | ||
2024/02/28 | Phase 4 | Recruiting | |||
2023/10/30 | Not Applicable | Completed | Morten Hostrup, PhD | ||
2022/09/23 | Not Applicable | Completed | |||
2021/06/24 | Phase 2 | Completed | UPECLIN HC FM Botucatu Unesp | ||
2021/05/19 | N/A | Completed | |||
2020/11/04 | Not Applicable | UNKNOWN | |||
2020/07/31 | Phase 1 | Completed | |||
2020/03/25 | Phase 3 | Active, not recruiting |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
---|---|---|---|---|---|
RESPIRATORY (INHALATION) | 4.5 ug in 1 1 | 2019/07/24 | 50090-6327 | ||
RESPIRATORY (INHALATION) | 12 ug in 1 1 | 2022/01/25 | 0310-0900 | ||
RESPIRATORY (INHALATION) | 4.5 ug in 1 1 | 2023/10/17 | 50090-1403 | ||
RESPIRATORY (INHALATION) | 20 ug in 2 mL | 2021/09/13 | 63629-8814 | ||
RESPIRATORY (INHALATION) | 15 ug in 2 mL | 2022/07/14 | 69097-168 | ||
RESPIRATORY (INHALATION) | 4.5 ug in 1 1 | 2019/07/24 | 53002-2666 | ||
RESPIRATORY (INHALATION) | 15 ug in 2 mL | 2023/03/15 | 70756-612 | ||
RESPIRATORY (INHALATION) | 20 ug in 2 mL | 2020/06/29 | 62332-655 | ||
RESPIRATORY (INHALATION) | 0.02 mg in 2 mL | 2023/01/09 | 73289-0060 | ||
RESPIRATORY (INHALATION) | 20 ug in 2 mL | 2023/06/01 | 42858-094 |
EMA Approved Products
Product Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
---|
No EMA products found
No EMA products found for this drug
HSA Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval Number |
---|---|---|---|---|---|
AEROSOL, METERED | 4.5 mcg/actuation | 2016/02/24 | SIN14962P | ||
POWDER, METERED | 9 mcg / inhalation | 2020/12/07 | SIN16057P | ||
POWDER, METERED | 6mcg/dose | 2017/09/19 | SIN15332P | ||
POWDER, METERED | 4.5 mcg / inhalation | 2020/12/07 | SIN16056P | ||
AEROSOL, METERED | 2.25 mcg/actuation | 2016/02/24 | SIN14963P | ||
AEROSOL, METERED | 2.25 mcg/actuation | 2016/02/24 | SIN14964P | ||
AEROSOL, METERED | 4.5 mcg/actuation | 2016/02/24 | SIN14961P |
NMPA Approved Products
Product Name | Approval Number | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
---|---|---|---|---|---|---|---|---|---|
国药准字H20103179 | 吸入剂 | N/A | 12μg(按无水富马酸福莫特罗计) | Chemical Drug | Approved | 2020/04/08 | Domestic | ||
国药准字HJ20130379 | 吸入粉雾剂 | 奥克斯都保 | 每吸9.0μg,60吸/支 | Chemical Drug | Approved | 2022/12/28 | Import | ||
国药准字HJ20130378 | 吸入粉雾剂 | 奥克斯都保 | 每吸4.5μg,60吸/支 | Chemical Drug | Approved | 2022/12/28 | Import | ||
国药准字H20080780 | 片剂 | N/A | 40μg | Chemical Drug | Approved | 2023/05/22 | Domestic | ||
国药准字H20010434 | 片剂 | 安通克 | 40μg | Chemical Drug | Approved | 2015/08/15 | Domestic | ||
国药准字H20040943 | 片剂 | 盼得欣 | 40μg | Chemical Drug | Approved | 2020/09/25 | Domestic | ||
国药准字H20249786 | 吸入制剂 | N/A | 2ml:20μg(按(C₁₉H₂₄N₂O₄)₂•C₄H₄O₄计) | Chemical Drug | Approved | 2024/12/25 | Domestic | ||
国药准字H20253076 | 吸入制剂 | N/A | 2ml:20µg [按(C₁₉H₂₄N₂O₄)₂•C₄H₄O₄计] | Chemical Drug | Approved | 2025/01/08 | Domestic | ||
国药准字H20253077 | 吸入制剂 | N/A | 2ml:20μg(按(C₁₉H₂₄N₂O₄)₂•C₄H₄O₄ 计) | Chemical Drug | Approved | 2025/01/08 | Domestic | ||
国药准字H20253128 | 吸入制剂 | N/A | 2ml : 20μg(按(C₁₉H₂₄N₂O₄)₂•C₄H₄O₄计) | Chemical Drug | Approved | 2025/01/14 | Domestic |
PPB Approved Products
Product Name | Registration Code | Company | Category | Sale Type | Registration Date |
---|
No PPB products found
No PPB products found for this drug
TGA Approved Products
Product Name | ARTG ID | Sponsor | Status | Registration Date | Ingredient |
---|---|---|---|---|---|
58673 | Active | 1997/01/29 | formoterol fumarate |