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Foradil (FORMOTEROL)
Foradil works by stimulating the beta-2 adrenergic receptor to relax airway muscles and improve breathing.
Foradil (Formoterol) is a small molecule beta2-adrenergic agonist developed by Novartis, targeting the beta-2 adrenergic receptor to treat various respiratory conditions. It is used as an adjunct therapy for long-term asthma control, prevention of bronchospasm in COPD, and exercise-induced bronchospasm prevention. Foradil is off-patent, with 10 generic manufacturers available. It was FDA-approved in 2001 for multiple indications, including allergic and non-allergic asthma, COPD, and pulmonary emphysema. As a commercial product, its availability and pricing may vary depending on the region and manufacturer.
At a glance
| Generic name | FORMOTEROL |
|---|---|
| Sponsor | Novartis |
| Drug class | beta2-Adrenergic Agonist |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2001 |
Mechanism of action
Formoterol fumarate is long-acting, beta2-adrenergic receptor agonist (beta2-agonist). Inhaled formoterol fumarate acts locally in the lung as bronchodilator. In vitro studies have shown that formoterol has more than 200-fold greater agonist activity at beta2-receptors than at beta1-receptors. Although beta2-receptors are the predominant adrenergic receptors in bronchial smooth muscle and beta1-receptors are the predominant receptors in the heart, there are also beta2-receptors in the human heart comprising 10% to 50% of the total betaadrenergic receptors. The precise function of these receptors has not been established, but they raise the possibility that even highly selective beta2-agonists may have cardiac effects. The pharmacologic effects of beta2-adrenoceptor agonist drugs, including formoterol, are at least in part attributable to stimulation of intracellular adenyl cyclase, the enzyme that catalyzes the conversion of adenosine triphosphate (ATP) to cyc
Approved indications
- Adjunct Therapy to Achieve Long-term Asthma Control
- Allergic asthma
- Bronchospasm Prevention with COPD
- COPD Associated with Chronic Bronchitis
- Exercise-Induced Bronchospasm Prevention
- Non-allergic asthma
- Pulmonary emphysema
- Severe chronic obstructive pulmonary disease
Common side effects
- Diarrhea
- Nausea
- Nasopharyngitis
- Dry Mouth
- Vomiting
- Dizziness
- Insomnia
- Angina
- Hypertension
- Hypotension
- Tachycardia
- Arrhythmias
Drug interactions
- High Risk QT Prolonging Agents
Key clinical trials
- Study in Adult Patients With Moderate to Severe Asthma (PHASE3)
- Study of Lunsekimig (SAR443765) Compared With Placebo in Adults With High-risk Asthma (PHASE2)
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting (STRENGTH)
- Pooled Analysis of Single-arm Studies of Budesonide/Glycopyrronium/Formoterol (BGF) in Routine Care Setting
- Fixed Triple Inhaled Combination in Asthmatic Patients in a Real-life Setting
- 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 (PHASE4)
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (PHASE3)
- Post-marketing Phase 4 Safety & Tolerability Study of Breztri aerosphereTM in Indian Patients With Chronic Obstructive Pulmonary Disease (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |