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Formoterol MDI
Formoterol MDI is a Long-acting beta-2 agonist (LABA) Small molecule drug developed by Organon and Co. It is currently in Phase 3 development for Asthma maintenance therapy, Chronic obstructive pulmonary disease (COPD) maintenance therapy. Also known as: Foradil.
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 MDI is a small molecule medication used to treat conditions such as Chronic Obstructive Pulmonary Disease and Asthma. It is administered via a metered-dose inhaler (MDI) and is available under various product names including PT003, PT001, and PT005.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Formoterol MDI |
|---|---|
| Also known as | Foradil |
| Sponsor | Organon and Co |
| 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 cells, triggering a cascade that increases intracellular cAMP levels, leading to smooth muscle relaxation and sustained bronchodilation. The long-acting formulation provides extended therapeutic effect, typically lasting 12 hours or more, making it suitable for maintenance therapy in chronic respiratory conditions.
Approved indications
- Asthma maintenance therapy
- Chronic obstructive pulmonary disease (COPD) maintenance therapy
Common side effects
- Tremor
- Headache
- Palpitations
- Nervousness
- Muscle cramps
Key clinical trials
- Study in Adult Patients With Moderate to Severe Asthma (PHASE3)
- 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)
- Ventilation and Perfusion in Asthmatics (PHASE4)
- A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Different Devices in Participants Aged 4 to Less Than 12 Years Old With Asthma (PHASE1)
- A Study to Evaluate the Effect of Budesonide, Glycopyrronium, Formoterol Fumarate (BGF) Metered Dose Inhaler (MDI), Budesonide and Formoterol Fumarate (BFF) MDI and Placebo MDI on Exercise Parameters in Participants With Chronic Obstructive Pulmonary Disease (COPD). (PHASE3)
- A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (PHASE3)
- Impact of Inhaled PT003 on Complexity and Variability of Tidal Breathing and Oscillatory Mechanics in Stable COPD Patient (PHASE2)
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 MDI CI brief — competitive landscape report
- Formoterol MDI updates RSS · CI watch RSS
- Organon and Co portfolio CI
Frequently asked questions about Formoterol MDI
What is Formoterol MDI?
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Is Formoterol MDI also known as anything else?
What drug class is Formoterol MDI in?
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What are the side effects of Formoterol MDI?
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Related
- Drug class: All Long-acting beta-2 agonist (LABA) drugs
- Target: All drugs targeting Beta-2 adrenergic receptor
- Manufacturer: Organon and Co — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Asthma maintenance therapy
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance therapy
- Also known as: Foradil
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing