Hyaluronidase (human recombinant)
Hyaluronidase (human recombinant) is an enzyme pharmaceutical. It is currently being investigated in clinical studies.
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Variants
Financial
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Events Timeline
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YTD
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2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
No data
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
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
197 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | — | 2 | 2 | — | — | 4 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | 1 | — | — | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 3 | — | — | — | 5 |
| Neoplasms by site | D009371 | — | — | 1 | 1 | — | — | — | 1 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 1 | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Patient preference | D057240 | — | — | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lung neoplasms | D008175 | — | C34.90 | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
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
No data
Variants
No data
Financial
Revenue by drug
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€
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Phesgo – Roche
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,603 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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