Hyaluronidase (human recombinant)
Hyaluronidase (human recombinant) is an enzyme pharmaceutical. It is currently being investigated in clinical studies.
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Commercial
Therapeutic Areas
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Trade Name
FDA
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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 | 2026-02-11 |
| herceptin hylecta | Biologic Licensing Application | 2026-05-29 |
| hylenex recombinant | Biologic Licensing Application | 2024-11-11 |
| phesgo | Biologic Licensing Application | 2026-05-21 |
| rybrevant faspro | Biologic Licensing Application | 2026-06-17 |
| vyvgart hytrulo | Biologic Licensing Application | 2026-07-15 |
Indications
FDA
EMA
Agency Specific
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HCPCS
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Clinical
Clinical Trials
212 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 12 | 9 | 4 | 1 | — | 24 |
| Healthy volunteers/patients | — | — | — | 19 | — | 1 | 2 | — | 22 |
| Primary immunodeficiency diseases | D000081207 | — | — | 1 | 3 | 8 | 1 | 4 | 14 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | 1 | 5 | 1 | 3 | 9 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 2 | 3 | — | 3 | — | 8 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 4 | 3 | — | 1 | — | 8 |
| Dehydration | D003681 | — | E86.0 | 1 | — | — | 6 | 1 | 8 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | — | — | 1 | — | 3 |
| Cardiac output | D002302 | — | — | — | — | — | 1 | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | — | 1 | — | 1 |
Show 1 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 15 | 10 | 1 | — | — | 19 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 7 | 6 | — | 1 | 16 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | 3 | 3 | — | — | 9 |
| B-cell lymphoma | D016393 | — | — | 4 | 4 | 1 | — | — | 7 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 4 | 2 | — | — | 6 |
| Plasma cell neoplasms | D054219 | — | — | 4 | 2 | 1 | — | — | 6 |
| Melanoma | D008545 | — | — | — | 3 | 2 | — | — | 5 |
| Immunoglobulin light-chain amyloidosis | D000075363 | — | — | — | 2 | 1 | — | 2 | 5 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | 1 | 3 | 1 | — | — | 4 |
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | — | 4 | — | — | 4 |
Show 25 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 6 | 6 | — | — | — | 10 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 6 | 1 | — | — | — | 7 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 2 | — | — | 1 | 5 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | 1 | — | — | — | 4 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 2 | — | — | — | 3 |
| Urinary bladder neoplasms | D001749 | — | C67 | 3 | 1 | — | — | — | 3 |
| Male breast neoplasms | D018567 | — | — | — | 3 | — | — | — | 3 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | — | 1 | — | — | 1 | 2 |
| Leukemia | D007938 | — | C95 | 1 | 1 | — | — | — | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 1 | — | — | — | 2 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | — | — | — | — | 2 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | 2 | — | — | — | — | 2 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | — | — | — | — | 1 |
| Monocytic leukemia acute | D007948 | — | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | — | — | — | — | 1 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 1 | — | — | — | — | 1 |
| Castleman disease | D005871 | EFO_1001332 | D47.Z2 | 1 | — | — | — | — | 1 |
| Sclerosis | D012598 | — | — | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
Show 14 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | — | — | — | — | 1 | 1 |
| Stiff-person syndrome | D016750 | EFO_0007498 | G25.82 | — | — | — | — | 1 | 1 |
| Neuritis | D009443 | — | — | — | — | — | — | 1 | 1 |
| Pneumonia | D011014 | EFO_0003106 | J18 | — | — | — | — | 1 | 1 |
| Pneumococcal pneumonia | D011018 | EFO_1001474 | J13 | — | — | — | — | 1 | 1 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | — | — | — | — | 1 | 1 |
| Emergencies | D004630 | — | — | — | — | — | — | 1 | 1 |
| Pain management | D059408 | — | — | — | — | — | — | 1 | 1 |
| Agnosia | D000377 | EFO_0007136 | F88 | — | — | — | — | 1 | 1 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | — | 1 | 1 |
Show 3 more
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
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Financial
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Phesgo – Roche
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Trends
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Safety
Black-box Warning
Black-box warning for: Herceptin hylecta, Phesgo
Adverse Events
Top Adverse Reactions
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19,474 adverse events reported
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