PULMOZYME

(Dornase alfa)

ApprovedProtein / enzyme

Roche

PULMOZYME is one of 107 small molecule programs targeting Cystic Fibrosis. It is currently in Approved.

Indications

Total Trials

Active Trials

106

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cystic FibrosisTerminated

COVID-19Terminated

Ischemic StrokeRecruiting

Cystic FibrosisApproved

Terminated

COVID-19Approved

Terminated

Ischemic StrokePhase 2

Recruiting

Competition

Competitive Landscape

309 competitors in COVID-19

#DrugCompanyPhaseTrials

PULMOZYME

Roche

Approved

3 2

Stivarga

Bayer

Preclinical

1 3

Aimovig

Amgen

Preclinical

1 4

Aldactone

Pfizer

Preclinical

1 5

Nexavar

Bayer

Preclinical

1 6

Calciferol

Activella

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 9

Tricor

JJagotec

Preclinical

1 10

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2028

Phase 2Recruiting

Ischemic Stroke

NCT05880524

Q3 2030

Phase 2Active, not recruiting

COVID-19

NCT04488081

Clinical

Trials by Indication[1]

COVID-193 trials

I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients

Active, not recruiting·QQuantumLeap Healthcare Collaborative·Phase 2·NCT04488081·1,500 enrolled

Dornase Alfa Administered to Patients With COVID-19 (DACOVID)

Completed·FFeinstein Institute for Medical Research··NCT04387786·5 enrolled

Usefulness of DORNASE in COVID-19 on HFNO

Terminated·UUniversity Medical Centre Ljubljana·Phase 4·NCT05139901·10 enrolled

Cystic Fibrosis3 trials

A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)

Terminated· Roche logo

Roche·Phase 4·NCT00434278·27 enrolled

A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis

Completed· Roche logo

Roche·Phase 4·NCT01712334·99 enrolled

A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis

Terminated· Roche logo

Roche·Phase 4·NCT00680316·3 enrolled

Ischemic stroke2 trials

Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase)

Recruiting·UUniversity of Melbourne·Phase 2·NCT05203224·300 enrolled

Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD)

Recruiting·LLudwig-Maximilians - University of Munich·Phase 2·NCT05880524·36 enrolled

Ventilation Therapy1 trial

Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient

Completed·—·Phase 4·NCT02168387·39 enrolled

MPA1 trial

A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects

Completed·JJHL Biotech, Inc.·Phase 1·NCT03586076·24 enrolled

6 more indications

Intensive Care Unit1 trial

Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU)

Completed·GGeorgetown University·Phase 4·NCT01356147·11 enrolled

Cough1 trial

Pulmozyme for Sjogren's Associated Cough

Withdrawn·UUConn Health·Phase 1·NCT01357447

Lung Transplant1 trial

Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.

Completed·TThe Alfred·Phase 2·NCT01952470·32 enrolled

Chronic Rhinosinusitis1 trial

Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis

Completed·UUniversity of Jena·Phase 3·NCT00534079·23 enrolled

Treatment1 trial

Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

Completed·UUniversity of Colorado, Denver·Phase 4·NCT00419380·40 enrolled

Ventilation1 trial

Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa

Unknown status·UUniversity Hospital Tuebingen·Phase 2/3·NCT00204685·540 enrolled

Regulatory

FDA Approval Timeline[4]

Dec 30, 1993

PULMOZYME

BLA BLA103532

Sources

References

[1]
ClinicalTrials.gov — 16 trial records for Dornase alfa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dornase alfa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dornase alfa. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA103532). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Protein / enzyme[2]
Highest Phase: Approved[1]
Company: Roche

PULMOZYME

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2028

Q3 2030

Trials by Indication[1]

COVID-193 trials

Cystic Fibrosis3 trials

Ischemic stroke2 trials

Ventilation Therapy1 trial

MPA1 trial

Intensive Care Unit1 trial

Cough1 trial

Lung Transplant1 trial

Chronic Rhinosinusitis1 trial

Treatment1 trial

Ventilation1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News