Last reviewed · How we verify
CHF1535 NEXThaler
CHF1535 NEXThaler is a Corticosteroid-anticholinergic combination Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 2 development for Chronic obstructive pulmonary disease (COPD), Asthma. Also known as: Foster NEXThaler.
CHF1535 NEXThaler is a dry powder inhaler delivering a fixed dose of a combination of fluticasone furoate and umeclidinium
The CHF1535 NEXThaler is a combination inhaler that contains beclomethasone and formoterol, used to treat asthma in children aged 5-11 years old. It is administered via a dry powder inhaler (DPI) and is available in a 35/4µg formulation.
-
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 | CHF1535 NEXThaler |
|---|---|
| Also known as | Foster NEXThaler |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Drug class | Corticosteroid-anticholinergic combination |
| Modality | Small molecule |
| Therapeutic area | Respiratory |
| Phase | Phase 2 |
Mechanism of action
Fluticasone furoate is a corticosteroid that reduces inflammation in the airways, while umeclidinium is an anticholinergic that relaxes bronchial muscles to improve airflow.
Approved indications
- Chronic obstructive pulmonary disease (COPD)
- Asthma
Common side effects
- Cough
- Headache
- Oral candidiasis
- Upper respiratory tract infection
- Nausea
Key clinical trials
- A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients (PHASE2)
- Lung Bioavailability and Total Systemic Exposure to Beclomethasone17MonoPropionate and Formoterol Across Two Strengths of NEXThaler Inhalation Powder (PHASE2)
- A Study to Evaluate the Onset of Relief From Methacholine-induced Bronchoconstriction With CHF1535 NEXThaler in Asthmatic Patients. (PHASE2)
- Comparison of Combination of Beclomethasone Dipropionate and Formoterol Fumarate Versus Single Components Assessed by Knemometry and Urinary Cortisol Measurements in Asthmatic Children (PHASE3)
- Clinical Pharmacology of 35/4 NEXThaler® in Children 5-11 Years Old (PHASE2)
- A Study to Evaluate the Acute Bronchodilator Effect of CHF1535 NEXThaler (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:
- CHF1535 NEXThaler CI brief — competitive landscape report
- CHF1535 NEXThaler updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about CHF1535 NEXThaler
What is CHF1535 NEXThaler?
How does CHF1535 NEXThaler work?
What is CHF1535 NEXThaler used for?
Who makes CHF1535 NEXThaler?
Is CHF1535 NEXThaler also known as anything else?
What drug class is CHF1535 NEXThaler in?
What development phase is CHF1535 NEXThaler in?
What are the side effects of CHF1535 NEXThaler?
Related
- Drug class: All Corticosteroid-anticholinergic combination drugs
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Chronic obstructive pulmonary disease (COPD)
- Indication: Drugs for Asthma
- Also known as: Foster NEXThaler
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing