PULMOZYME (dornase alfa)
Pulmozyme (dornase alfa) is a recombinant human deoxyribonuclease 1 indicated for the management of cystic fibrosis in both pediatric and adult patients. Used in conjunction with standard therapies, the medication is intended to improve pulmonary function and reduce the risk of respiratory tract infections requiring parenteral antibiotics in specific patient populations. It addresses the clinical challenges associated with the retention of viscous purulent secretions in the airways.
How PULMOZYME Works
Pulmozyme is a recombinant human deoxyribonuclease I enzyme that functions by selectively cleaving DNA. In cystic fibrosis patients, purulent pulmonary secretions contain high concentrations of extracellular DNA released by degenerating leukocytes. The enzyme hydrolyzes this DNA to reduce the viscoelasticity of the sputum, addressing the secretions that contribute to reduced pulmonary function and exacerbations of infection.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1993-12-30
- Patent Cliff
- 2000
- Revenue
- $139M (Q4-2025)
- Routes
- N/A
- Dosage Forms
- VIAL
PULMOZYME Approval History
What PULMOZYME Treats
2 indicationsPULMOZYME is approved for 2 conditions since its original approval in 1993. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cystic Fibrosis
- Respiratory Tract Infection
PULMOZYME Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to PULMOZYME
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05203224 | MBC2101 | Ph 2 | completed | Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase) |
| NCT04488081 I-SPY_COVID | I-SPY-COVID | Ph 2 | active not recruiting | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT05139901 | DTS_pulmosyme | Ph 4 | terminated | Usefulness of DORNASE in COVID-19 on HFNO |
| NCT00843817 BioDNase | PHAO08-PD BioDNase | Ph 4 | completed | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum |
| NCT01357447 | 11-110-3 002 | Ph 1 | withdrawn | Pulmozyme for Sjogren's Associated Cough |
| NCT03586076 | JHL-CLIN-1922-01 | Ph 1 | completed | A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects |
| NCT01952470 results posted | 342/13 DOI:10.1111/tri.13400 | Ph 2 | completed | Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant. |
| NCT01356147 PVAIN results posted | Z4962s | Ph 4 | completed | Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU) |
| NCT00680316 results posted | Z4240g | Ph 4 | terminated | A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis |
| NCT02168387 results posted | Pro00026503 | Ph 4 | completed | Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
PULMOZYME FDA Label Details
Indications & Usage
FDA Label (PDF)PULMOZYME is indicated for the treatment of Cystic Fibrosis; Respiratory Tract Infection.
Pro Intelligence Preview
Deep insights for PULMOZYME
Revenue Insights
- • Q4-2025: $139M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2000
- • Generic/biosimilar risk
Trial Analysis
- • 11 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment