Hyaluronidase (human recombinant)
Hyaluronidase (human recombinant) is an enzyme pharmaceutical. It is currently being investigated in clinical studies.
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Events
FDA approval date
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Study first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Hylenex recombinant
CombinationsRituxan hycela
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)
Hyaluronidase human
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Hylenex recombinant | hyaluronidase human | Halozyme Therapeutics | N-21859 RX | 2005-12-02 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| darzalex faspro | Biologic Licensing Application | 2024-08-08 |
| herceptin hylecta | Biologic Licensing Application | 2024-11-21 |
| hylenex recombinant | Biologic Licensing Application | 2024-11-11 |
| phesgo | Biologic Licensing Application | 2024-12-02 |
| vyvgart hytrulo | Biologic Licensing Application | 2025-04-14 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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ATC Codes
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HCPCS
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Clinical
Clinical Trials
197 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | — | 1 | — | — | — | 1 |
| Cutaneous malignant melanoma | D000096142 | — | — | — | 1 | — | — | — | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | 1 | — | — | — | 1 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | — | — | — | — | 2 |
| B-cell lymphoma | D016393 | — | — | 2 | — | — | — | — | 2 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | — | — | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | 1 | — | — | — | — | 1 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Recurrence | D012008 | — | — | 1 | — | — | — | — | 1 |
| Carcinoma | D002277 | — | C80.0 | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
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Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hyaluronidase (human recombinant) |
| INN | vorhyaluronidase alfa |
| Description | Hyaluronidase (human recombinant) is an enzyme pharmaceutical. It is currently being investigated in clinical studies. |
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201718 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 743QUY4VD8 (ChemIDplus, GSRS) |
Target
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Variants
No data
Financial
Revenue by drug
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Phesgo – Roche
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Tabular view
Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,587 documents
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Safety
Black-box Warning
Black-box warning for: Herceptin hylecta, Phesgo
Adverse Events
Top Adverse Reactions
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16,811 adverse events reported
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