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Dornase Alfa Inhalation Solution
Dornase Alfa Inhalation Solution is a Recombinant enzyme Small molecule drug developed by University of Missouri-Columbia. It is currently in Phase 3 development for Cystic fibrosis with airway obstruction, Chronic suppurative airway disease with thick secretions. Also known as: Pulmozyme.
Dornase alfa is a recombinant human deoxyribonuclease that cleaves extracellular DNA in airway secretions to reduce mucus viscosity and improve clearance.
Dornase alfa is a recombinant human deoxyribonuclease that cleaves extracellular DNA in airway secretions to reduce mucus viscosity and improve clearance. Used for Cystic fibrosis with airway obstruction, Chronic suppurative airway disease with thick secretions.
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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 | Dornase Alfa Inhalation Solution |
|---|---|
| Also known as | Pulmozyme |
| Sponsor | University of Missouri-Columbia |
| Drug class | Recombinant enzyme |
| Target | Extracellular DNA (deoxyribonucleic acid) |
| Modality | Small molecule |
| Therapeutic area | Pulmonology / Respiratory |
| Phase | Phase 3 |
Mechanism of action
In cystic fibrosis and other conditions with thick, purulent airway secretions, neutrophil death releases DNA that increases sputum viscosity and impairs mucociliary clearance. Dornase alfa enzymatically degrades this extracellular DNA, reducing sputum viscoelasticity and facilitating expectoration. This improves airway function and reduces infection risk.
Approved indications
- Cystic fibrosis with airway obstruction
- Chronic suppurative airway disease with thick secretions
Common side effects
- Voice hoarseness
- Pharyngitis
- Laryngitis
- Chest pain
- Dyspnea
Key clinical trials
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Pleural Irrigation With Normal Saline Versus Intrapleural Fibrinolytic (NA)
- Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target) (PHASE2)
- Investigator Initiated Study to Assess the Safety of Combination of CLS-015 With Anti-CD-19 CAR-T Cells in Patients With Stable/Progressive Large B Cell Lymphoma at Lymphodepletion. (PHASE1)
- Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer. (PHASE2)
- Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (PHASE3)
- Efficacy of Daily IV Administration of Dornase Alfa Up to 14 Days Post Subarachnoid Hemorrhage on Functional Independence At 6 Months (PHASE2)
- Nebulised Dornase Alfa for Treatment of COVID-19 (Coronavirus Disease 2019) (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:
- Dornase Alfa Inhalation Solution CI brief — competitive landscape report
- Dornase Alfa Inhalation Solution updates RSS · CI watch RSS
- University of Missouri-Columbia portfolio CI
Frequently asked questions about Dornase Alfa Inhalation Solution
What is Dornase Alfa Inhalation Solution?
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Is Dornase Alfa Inhalation Solution also known as anything else?
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What does Dornase Alfa Inhalation Solution target?
Related
- Drug class: All Recombinant enzyme drugs
- Target: All drugs targeting Extracellular DNA (deoxyribonucleic acid)
- Manufacturer: University of Missouri-Columbia — full pipeline
- Therapeutic area: All drugs in Pulmonology / Respiratory
- Indication: Drugs for Cystic fibrosis with airway obstruction
- Indication: Drugs for Chronic suppurative airway disease with thick secretions
- Also known as: Pulmozyme
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing