PULMOZYME

(Dornase alfa)

ApprovedProtein / enzyme

Roche

PULMOZYME is one of 111 small molecule programs targeting Chronic Rhinosinusitis. It is currently in Approved.

Indications

Total Trials

Active Trials

110

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Chronic RhinosinusitisActive, not recruiting

Cystic FibrosisActive, not recruiting

COVID-19Active, not recruiting

Ischemic StrokeActive, not recruiting

Chronic RhinosinusitisPhase 3

Active, not recruiting

Cystic FibrosisApproved

Active, not recruiting

COVID-19Phase 2

Active, not recruiting

Ischemic StrokePhase 2

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

PULMOZYME

Roche

Approved

3 2

Bnt162b2

BioNTech

Preclinical

29 3

Biaxin

AbbVie

Preclinical

2 4

Aldactone

Pfizer

Preclinical

1 5

Calciferol

Alnylam Pharmaceuticals

Preclinical

—6

Angiomax

BBaxter Healthcare Corporation

Preclinical

2 7

Tricor

JJagotec

Preclinical

1 8

Precedex

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

Preclinical

1 9

Low-Molecular-Weight Heparin

Daiichi Sankyo

Preclinical

3 10

HB-Admscs

HHope Biosciences Research Foundation

Preclinical

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

Timeline

Expected Milestones

Q3 2030

Phase 2Active, not recruiting

COVID-19

NCT04488081

Clinical

Trials by Indication[1]

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

Terminated· Roche logo

Roche·Phase 4·NCT00680316·3 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

COVID-193 trials

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

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

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)

Not yet recruiting·LLudwig-Maximilians - University of Munich·Phase 2·NCT05880524·36 enrolled

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

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

6 more indications

MPA1 trial

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

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

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

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

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 2030

Trials by Indication[1]

Cystic Fibrosis3 trials

COVID-193 trials

Ischemic stroke2 trials

Intensive Care Unit1 trial

Ventilation Therapy1 trial

MPA1 trial

Cough1 trial

Lung Transplant1 trial

Ventilation1 trial

Chronic Rhinosinusitis1 trial

Treatment1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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