Dornase alfa
Pulmozyme (dornase alfa) is an enzyme pharmaceutical. Dornase alfa was first approved as Pulmozyme on 1993-12-30. It is used to treat bronchitis and cystic fibrosis in the USA.
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Commercial
Trade Name
FDA
EMA
Pulmozyme
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Dornase alfa
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Pulmozyme | dornase alfa | Genentech | N-103532 RX | 1993-12-30 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pulmozyme | Biologic Licensing Application | 2020-10-21 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bronchitis | — | D001991 | J40 |
| cystic fibrosis | EFO_0000390 | D003550 | E84 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
dornase alfa, Pulmozyme, Genentech, Inc. | |||
| 2100-12-30 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J7639 | Dornase alfa, inhalation solution, fda-approved final product, non-compounded, administered through dme, unit dose form, per milligram |
Clinical
Clinical Trials
46 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 3 | 4 | 5 | 2 | 14 |
| Pulmonary atelectasis | D001261 | J98.1 | — | — | — | 1 | 2 | 3 | |
| Pulmonary infarction | D054060 | EFO_1001408 | — | — | — | 1 | — | 1 | |
| Otitis media | D010033 | EFO_0004992 | H66.9 | — | — | — | 1 | — | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | U07.1 | 1 | 5 | 1 | — | 1 | 8 | |
| Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | — | — | 2 | — | — | 2 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | 1 | 1 | — | — | 2 |
| Fibrosis | D005355 | — | — | 1 | — | — | 1 | ||
| Sars-cov-2 | D000086402 | — | — | 1 | — | — | 1 | ||
| Multiple trauma | D009104 | T07 | — | — | 1 | — | — | 1 | |
| Pleural empyema | D016724 | J86 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ischemic stroke | D000083242 | — | 2 | — | — | — | 2 | ||
| Hypoxia | D000860 | R09.02 | — | 1 | — | — | — | 1 | |
| Dry eye syndromes | D015352 | H04.12 | 1 | 1 | — | — | — | 1 | |
| Respiratory tract infections | D012141 | J06.9 | — | 1 | — | — | — | 1 | |
| Asthma | D001249 | EFO_0000270 | J45 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 | ||
| Malignant pleural effusion | D016066 | J91.0 | 1 | — | — | — | — | 1 | |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | 1 | — | — | — | — | 1 |
| Cough | D003371 | HP_0012735 | R05 | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Artificial respiration | D012121 | — | — | — | — | 2 | 2 | ||
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | DORNASE ALFA |
| INN | dornase alfa |
| Description | Deoxyribonuclease I precursor (DNase I) (Dornase alfa) |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 4AWN |
| CAS-ID | 9003-98-9 |
| RxCUI | 337623 |
| ChEMBL ID | CHEMBL1201431 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00003 |
| UNII ID | 953A26OA1Y (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Pulmozyme - Roche
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,595 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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163 adverse events reported
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