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Pulmozyme (DORNASE ALFA)
Pulmozyme (generic name: DORNASE ALFA) is a Recombinant Human Deoxyribonuclease 1 [EPC] Enzyme drug developed by Roche. It is currently FDA-approved (first approved 1993) for Cystic fibrosis.
Pulmozyme breaks down DNA in the airways to reduce mucus viscosity.
Pulmozyme (DORNASE ALFA) is a recombinant human deoxyribonuclease 1, a small molecule drug developed by Genentech and approved by the FDA in 1993 for the treatment of cystic fibrosis. It works by breaking down DNA in the airways, reducing the viscosity of mucus and making it easier to clear. Pulmozyme is a patented product and its commercial status is owned by Genentech. Key safety considerations include potential local irritation and allergic reactions. It is used to help manage symptoms of cystic fibrosis.
At a glance
| Generic name | DORNASE ALFA |
|---|---|
| Sponsor | Roche |
| Drug class | Recombinant Human Deoxyribonuclease 1 [EPC] |
| Modality | Enzyme |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
| First approval | 1993 |
Mechanism of action
PULMOZYME is recombinant human deoxyribonuclease (rhDNase), an enzyme which selectively cleaves DNA. In preclinical in vitro studies, PULMOZYME hydrolyzes the DNA in sputum of CF patients and reduces sputum viscoelasticity. In CF patients, retention of viscous purulent secretions in the airways contributes both to reduced pulmonary function and to exacerbations of infection. Purulent pulmonary secretions contain very high concentrations of extracellular DNA released by degenerating leukocytes that accumulate in response to infection.
Approved indications
- Cystic fibrosis
Common side effects
- FVC decrease of >= 10%
- Fever
- Dyspnea (when reported as serious)
- Dyspnea (regardless of severity or seriousness)
- Chest Pain
- Voice alteration
- Pharyngitis
- Rash
- Laryngitis
- Conjunctivitis
- Rhinitis
- Cough
Key clinical trials
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Intrapleural Alteplase-Tyloxapol vs Intrapleural Alteplase-DNase in Pleural Infection
- 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)
- VATS Surgery Compared to Drainage in the Treatment of Pleural Empyema (NA)
- Dornase Alfa and Cisplatin in Refractory Germ Cell Cancer. (PHASE2)
- Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma (PHASE3)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- Pulmozyme CI brief — competitive landscape report
- Pulmozyme updates RSS · CI watch RSS
- Roche portfolio CI
Frequently asked questions about Pulmozyme
What is Pulmozyme?
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Related
- Drug class: All Recombinant Human Deoxyribonuclease 1 [EPC] drugs
- Manufacturer: Roche — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Cystic fibrosis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing