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.
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)
Research Report
Formoterol: A Comprehensive Pharmacological and Clinical Monograph
Section 1: Drug Substance Profile
This section establishes the fundamental identity of Formoterol, covering its chemical structure, nomenclature, and key physicochemical properties that influence its formulation and biological activity.
1.1 Identification and Nomenclature
Formoterol, also known by the alternative name eformoterol, is a small molecule drug classified as a selective beta-2 adrenergic receptor agonist.[1] It is identified globally through a standardized set of chemical names and identifiers.
- Drug Name: Formoterol [1]
- Systematic (IUPAC) Names:
- N-[2-hydroxy-5-(1-hydroxy-2-{[2-(4-methoxyphenyl)-1-methylethyl]amino}ethyl)phenyl]formamide [1]
- (RR,SS)-N-[2-hydroxy-5-[1-hydroxy-2-[1-(4-methoxyphenyl) propan-2-ylamino]ethyl] phenyl]formamide [2]
- Identifiers:
- DrugBank ID: DB00983 [1]
- CAS Number: 73573-87-2 (for the racemic free base) [2]
- Related CAS Numbers: 43229-80-7 (for Formoterol Fumarate) [5]
- Synonyms and Development Codes: The drug is known by numerous synonyms reflecting its global development and marketing history, including Formoterolum (the International Nonproprietary Name in Latin), Foradil, Oxis, BD 40A, and CGP-25827A.[1]
- Chemical Classifications: Formoterol belongs to several chemical and therapeutic classes, including Adrenergic Agonists, Selective Beta-2 Adrenergic Receptor Agonists, Phenylethanolamines, Formamides, and Phenols.[1]
1.2 Physicochemical Properties and Formulation Characteristics
The physical and chemical properties of formoterol are integral to its formulation as an inhaled medication and directly influence its unique pharmacological profile.
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/03/25 | Phase 3 | Active, not recruiting | |||
2019/11/12 | Phase 4 | Completed | |||
2019/10/23 | Not Applicable | UNKNOWN | Federal State Budgetary Institution, Pulmonology Scientific Research Institute | ||
2019/03/25 | Phase 3 | Completed | |||
2018/12/27 | Phase 4 | Completed | Istituto per la Ricerca e l'Innovazione Biomedica | ||
2018/06/29 | Phase 3 | Completed | |||
2018/06/21 | Not Applicable | UNKNOWN | Morten Hostrup, PhD | ||
2018/03/19 | Phase 3 | Completed | Shanghai Biomabs Pharmaceutical Co., Ltd. | ||
2017/08/25 | Phase 3 | Completed | |||
2017/08/23 | Not Applicable | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| A-S Medication Solutions | 50090-6327 | RESPIRATORY (INHALATION) | 4.5 ug in 1 1 | 7/24/2019 | |
| Bryant Ranch Prepack | 63629-8813 | RESPIRATORY (INHALATION) | 20 ug in 2 mL | 9/13/2021 | |
| Alembic Pharmaceuticals Inc. | 62332-633 | RESPIRATORY (INHALATION) | 15 ug in 2 mL | 5/16/2022 | |
| Lupin Pharmaceuticals, Inc. | 70748-175 | RESPIRATORY (INHALATION) | 15 ug in 2 mL | 12/14/2023 | |
| Organon LLC | 78206-127 | RESPIRATORY (INHALATION) | 5 ug in 1 1 | 6/5/2025 | |
| Lifestar Pharma LLC | 70756-612 | RESPIRATORY (INHALATION) | 15 ug in 2 mL | 3/15/2023 | |
| Covis Pharma US, Inc | 70515-001 | RESPIRATORY (INHALATION) | 12 ug in 1 1 | 8/1/2022 | |
| Mylan Pharmaceuticals Inc. | 0378-1631 | RESPIRATORY (INHALATION) | 20 ug in 2 mL | 12/15/2020 | |
| AstraZeneca Pharmaceuticals LP | 0310-0900 | RESPIRATORY (INHALATION) | 12 ug in 1 1 | 1/25/2022 | |
| Teva Pharmaceuticals USA, Inc. | 0093-4061 | RESPIRATORY (INHALATION) | 20 ug in 2 mL | 10/31/2020 |
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