Last reviewed · How we verify
CHF 6001 Dose1
CHF 6001 Dose1 is a Small molecule drug developed by Chiesi Farmaceutici S.p.A.. It is currently in Phase 2 development. Also known as: CHF 6001.
-
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 6001 Dose1 |
|---|---|
| Also known as | CHF 6001 |
| Sponsor | Chiesi Farmaceutici S.p.A. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- A Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF6001 (PHASE1)
- Pharmacodynamics, Pharmacokinetics and Safety of Two Doses of CHF6001 DPI in Subjects With Moderate, Severe COPD (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 6001 Dose1 CI brief — competitive landscape report
- CHF 6001 Dose1 updates RSS · CI watch RSS
- Chiesi Farmaceutici S.p.A. portfolio CI
Frequently asked questions about CHF 6001 Dose1
What is CHF 6001 Dose1?
Who makes CHF 6001 Dose1?
Is CHF 6001 Dose1 also known as anything else?
What development phase is CHF 6001 Dose1 in?
Related
- Manufacturer: Chiesi Farmaceutici S.p.A. — full pipeline
- Also known as: CHF 6001
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing