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Formoterol 12 µg DPI
Formoterol is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle to cause bronchodilation and improve airflow.
Formoterol is a long-acting beta-2 adrenergic agonist that binds to beta-2 receptors on airway smooth muscle to cause bronchodilation and improve airflow. Used for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy.
At a glance
| Generic name | Formoterol 12 µg DPI |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Long-acting beta-2 agonist (LABA) |
| Target | Beta-2 adrenergic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
Formoterol activates beta-2 adrenergic receptors on bronchial smooth muscle, triggering increased intracellular cAMP levels that lead to smooth muscle relaxation and sustained bronchodilation. The 12 µg dry powder inhaler (DPI) formulation provides rapid onset and long-acting bronchodilatory effects, typically lasting 12 hours, making it suitable for maintenance therapy in obstructive airway diseases.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Muscle cramps
- Nervousness
- Tachycardia
Key clinical trials
- Pressurized Meter Dose Inhaler V/S Dry Powder Inhaler (NA)
- Compare the Effects of Nebulizer Versus Inhaler Based Therapy for COPD Using Long-acting Bronchodilators (PHASE4)
- Efficacy and Safety Study of Beclometasone/Formoterol Single Inhaler in Patients With COPD (PHASE3)
- A Study Comparing the Pharmacokinetic, Pharmacodynamic and Safety of CHF 1535 (Fixed Combination of Beclomethasone + Formoterol) Administered Via the NEXT DPI, Versus the Free Combination of Licenced Beclomethasone DPI and Formoterol DPI in Asthmatic Adolescent and Adult Patients. (PHASE2)
- COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers (NA)
- A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma (PHASE3)
- Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients (PHASE3)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Formoterol 12 µg DPI CI brief — competitive landscape report
- Formoterol 12 µg DPI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI