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CHF 1535 pMDI
CHF 1535 pMDI is a Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 2 development.
CHF 1535 is a small molecule administered via a pressurized metered dose inhaler (pMDI) for the treatment of asthma and bronchial asthma. It contains a combination of budesonide (BDP) and formoterol (FF), which are used to manage symptoms of moderate to severe asthma.
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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 1535 pMDI |
|---|---|
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients (PHASE3)
- A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (PHASE3)
- A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared With CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (PHASE3)
- Foster® pMDI (CHF 1535) Versus Symbicort® Turbohaler in COPD Patient (PHASE3)
- Step-up to Medium Strength Triple Therapy vs High Strength ICS/LABA in Adult Asthmatics Uncontrolled on Medium Strength ICS/LABA (PHASE4)
- A Phase II, 5-way Cross-over Study to Evaluate the Pharmacodynamics of "Nexthaler" Dry Powder Inhaler in COPD Patients (PHASE2)
- Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD (PHASE3)
- Dose Response AMP Challenge Study With Beclometasone Dipropionate (BDP)/Formoterol Pressurised Metered Dose Inhaler (pMDI) (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:
- CHF 1535 pMDI CI brief — competitive landscape report
- CHF 1535 pMDI updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about CHF 1535 pMDI
What is CHF 1535 pMDI?
Who makes CHF 1535 pMDI?
What development phase is CHF 1535 pMDI in?
Related
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing