Last reviewed · How we verify
CHF 4226 pMDI
CHF 4226 pMDI is a LABA/LAMA combination bronchodilator Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 2 development for Chronic obstructive pulmonary disease (COPD) maintenance treatment. Also known as: Carmoterol HFA.
CHF 4226 is an inhaled dual bronchodilator combining a long-acting beta-2 agonist and long-acting muscarinic antagonist for maintenance treatment of chronic obstructive pulmonary disease.
CHF 4226 pMDI is a small molecule beta-2 adrenergic receptor agonist used to treat Chronic Obstructive Pulmonary Disease. It is administered via a pressurized metered-dose inhaler (pMDI) and has been studied in clinical trials for its effects on the QTc interval in healthy volunteers.
-
Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | CHF 4226 pMDI |
|---|---|
| Also known as | Carmoterol HFA |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | LABA/LAMA combination bronchodilator |
| Target | Beta-2 adrenergic receptor and M3 muscarinic receptor |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 2 |
Mechanism of action
The drug delivers two complementary bronchodilators via pressurized metered-dose inhaler (pMDI): a LABA component that activates beta-2 adrenergic receptors to increase cAMP and relax airway smooth muscle, and a LAMA component that blocks M3 muscarinic receptors to prevent acetylcholine-induced bronchoconstriction. This dual mechanism provides sustained airway dilation and improved lung function in COPD patients.
Approved indications
- Chronic obstructive pulmonary disease (COPD) maintenance treatment
Common side effects
- Tremor
- Headache
- Palpitations
- Dry mouth
- Nasopharyngitis
Key clinical trials
- Safety and Efficacy Study of Treatment With Single Doses of CHF 4226 pMDI in Patients With Chronic Obstructive Pulmonary Disease (COPD) (PHASE2)
- Dose Finding Study of CHF 4226 for Treating Patients With COPD (PHASE2)
- Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD (PHASE2)
- Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers (PHASE1)
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:
- CHF 4226 pMDI CI brief — competitive landscape report
- CHF 4226 pMDI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about CHF 4226 pMDI
What is CHF 4226 pMDI?
How does CHF 4226 pMDI work?
What is CHF 4226 pMDI used for?
Who makes CHF 4226 pMDI?
Is CHF 4226 pMDI also known as anything else?
What drug class is CHF 4226 pMDI in?
What development phase is CHF 4226 pMDI in?
What are the side effects of CHF 4226 pMDI?
What does CHF 4226 pMDI target?
Related
- Drug class: All LABA/LAMA combination bronchodilator drugs
- Target: All drugs targeting Beta-2 adrenergic receptor and M3 muscarinic receptor
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD) maintenance treatment
- Also known as: Carmoterol HFA
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing