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Formoterol

Generic Name
Formoterol
Brand Names
Bevespi, Breyna, Breztri, Duaklir, Duaklir Genuair, Dulera, Foradil, Oxeze, Perforomist, Symbicort, Zenhale
Drug Type
Small Molecule
Chemical Formula
C19H24N2O4
CAS Number
73573-87-2
Unique Ingredient Identifier
5ZZ84GCW8B

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

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
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