BLARESPIRATORY (INHALATION)VIALPriority Review
Approved
Dec 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Data completeness
4/8 — Partial
Priority Review
PULMOZYME (dornase alfa) by Roche. Approved for recombinant human deoxyribonuclease 1 [epc]. First approved in 1993.
Drug data last refreshed 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PULMOZYME (dornase alfa) is a recombinant human deoxyribonuclease 1 enzyme administered via inhalation to cystic fibrosis patients. It breaks down extracellular DNA in thick airway secretions, reducing sputum viscosity and improving lung function. The drug represents a foundational biologic therapy in respiratory disease management.
$0.002BPart D
LOE ApproachingLegacy product with modest Part D utilization and moderate competitive pressure suggests a stable but not growth-oriented team focused on market maintenance and patient access.
Mechanism of Action
Pharmacologic Class:
Recombinant Human Deoxyribonuclease 1
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (11)
Pulmozyme in Cystic Fibrosis With Sinusitis
Started Jul 2013
0SinusitisCystic Fibrosis
A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis
Started Dec 2012
99 enrolled
Cystic Fibrosis
Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)
Started May 2011
11 enrolled
Pulmonary Infections
A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
Started Jun 2008
3 enrolled
Cystic Fibrosis
Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy
Started Feb 2008
36 enrolled
Head and Neck Cancer
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.