Dornase Alfa
drugOn this page
Also known as Dornasa alfaDornase alfa (desoxyribonuclease)rdnarecombinantDornase alphaHuman dnase-1Pulmozyme
Summary
Dornase Alfa (CHEMBL1201431) is an approved enzyme (ATC R05CB13); indicated across 19 conditions including cystic fibrosis and empyema.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Enzyme
- ATC class: R05CB13
- Indications: 19 conditions
- Clinical trials: 23
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201431 |
| Name | Dornase Alfa |
| Type | Enzyme |
| Max phase | 4 |
| ATC | R05CB13 |
Also known as: Dornasa alfa, Dornase alfa, Dornase alfa (desoxyribonuclease), rdna, recombinant, Dornase alpha, Human dnase-1, Pulmozyme, DORNASE ALFA
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
19 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| cystic fibrosis | 4 | MONDO:0009061 | MONDO:0009061 |
| empyema | 3 | MONDO:0005242 | EFO:0003097 |
| sinusitis | 3 | MONDO:0005961 | EFO:0007486 |
| injury | 3 | MONDO:0021178 | EFO:0000546 |
| pleural empyema | 3 | MONDO:0018667 | EFO:0009680 |
| acute respiratory distress syndrome | 3 | MONDO:0006502 | EFO:1000637 |
| severe acute respiratory syndrome | 3 | MONDO:0005091 | EFO:0000694 |
| adult acute respiratory distress syndrome | 3 | MONDO:0100130 | MONDO:0100130 |
| asthma | 2 | MONDO:0004979 | MONDO:0004979 |
| dry eye syndrome | 1 | MONDO:0006733 | EFO:1000906 |
| Sjogren syndrome | 1 | MONDO:0010030 | EFO:0000699 |
| graft versus host disease | 1 | MONDO:0013730 | MONDO:0013730 |
| head and neck cancer | 0 | MONDO:0005627 | EFO:0006859 |
6 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 23.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 9 |
| PHASE4 | 6 |
| PHASE2/PHASE3 | 2 |
| PHASE1 | 2 |
| Not specified | 2 |
| PHASE3 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT00434278 | PHASE4 | TERMINATED | A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC) |
| NCT00680316 | PHASE4 | TERMINATED | A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis |
| NCT00843817 | PHASE4 | COMPLETED | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum |
| NCT01356147 | PHASE4 | COMPLETED | Dornase Alfa Therapy for Ventilator Associated Lung Infections in the Neonatal Intensive Care Unit (NICU) |
| NCT02168387 | PHASE4 | COMPLETED | Efficacy of Percussive Ventilation Therapy (MetaNeb ®) Compared With Mucolytic Agents for Atelectasis in the Mechanically Ventilated Pediatric Patient |
| NCT05139901 | PHASE4 | TERMINATED | Usefulness of DORNASE in COVID-19 on HFNO |
| NCT00204685 | PHASE2/PHASE3 | UNKNOWN | Time of Ventilation and Lung Function of Ventilated Patients Under Therapy With Dornase Alfa |
| NCT00265434 | PHASE3 | COMPLETED | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis |
| NCT00502632 | PHASE2/PHASE3 | UNKNOWN | Dornase Alfa and Urokinase for Kids With Pleural Empyema |
| NCT04445285 | PHASE2 | RECRUITING | Phase 2 Trial Using rhDNase to Reduce Mortality in COVID-19 Patients With Respiratory Failure |
| NCT04488081 | PHASE2 | ACTIVE_NOT_RECRUITING | I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients |
| NCT00117208 | PHASE2 | COMPLETED | Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis |
| NCT01952470 | PHASE2 | COMPLETED | Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant. |
| NCT04402944 | PHASE2 | UNKNOWN | Pulmozyme to Improve COVID-19 ARDS Outcomes |
| NCT04432987 | PHASE2 | UNKNOWN | Dornase Alpha for the Treatment of COVID-19 |
| NCT04785066 | PHASE2 | COMPLETED | Efficacy of Pulmozyme® on Arterial Recanalization in Post-thrombectomy Patients Managed for Ischemic Stroke (NETs-target) |
| NCT05203224 | PHASE2 | COMPLETED | Improving Early Reperfusion With Adjuvant Dornase Alfa in Large Vessel Ischemic Stroke (EXTEND-IA DNase) |
| NCT05880524 | PHASE2 | UNKNOWN | Reduction of SystemiC Inflammation After Ischemic Stroke by Intravenous DNase Administration (ReSCInD) |
| NCT01357447 | PHASE1 | WITHDRAWN | Pulmozyme for Sjogren’s Associated Cough |
| NCT03586076 | PHASE1 | COMPLETED | A Comparative Safety and Pharmacokinetic Study of JHL1922 and Pulmozyme® in Healthy Subjects |
| NCT00536952 | EARLY_PHASE1 | UNKNOWN | Pilot Study of Pulmozyme (rhDNase) in Patients With Head and Neck Cancers Treated With Radiation Therapy + Chemotherapy |
| NCT00671723 | Not specified | COMPLETED | Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients |
| NCT04387786 | Not specified | COMPLETED | Dornase Alfa Administered to Patients With COVID-19 (DACOVID) |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).