Hyaluronidase
Amphadase, Darzalex Faspro, Herceptin Hylecta, Phesgo, Vitrase, Vyvgart Hytrulo (hyaluronidase) is an enzyme pharmaceutical. Hyaluronidase was first approved as Vitrase on 2004-05-05. It is used to treat extravasation of diagnostic and therapeutic materials in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
| wounds and injuries | D014947 |
Trade Name
FDA
EMA
Amphadase, Vitrase (discontinued: Hydase)
CombinationsDarzalex faspro, Herceptin hylecta, Phesgo, Vyvgart hytrulo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amphadase | New Drug Application | 2016-11-28 |
| darzalex faspro | Biologic Licensing Application | 2023-11-28 |
| herceptin hylecta | Biologic Licensing Application | 2019-05-13 |
| hyaluronidase | Biologic Licensing Application | 2021-06-04 |
| hylenex recombinant | Biologic Licensing Application | 2024-01-24 |
| phesgo | Biologic Licensing Application | 2020-06-29 |
| rituxan hycela | Biologic Licensing Application | 2021-06-30 |
| sea clearly hydrating facial spf 35 kinetin | C200263 | 2023-12-05 |
| vitrase | Biologic Licensing Application | 2024-01-26 |
| vyvgart hytrulo | Biologic Licensing Application | 2023-12-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| extravasation of diagnostic and therapeutic materials | — | D005119 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
efgartigimod alfa / hyaluronidase, Vyvgart Hytrulo, Argenx BV | |||
| 2030-06-20 | Orphan excl. | ||
daratumumab / hyaluronidase, Darzalex Faspro, Janssen Biotech, Inc. | |||
| 2028-01-15 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J1575 | Injection, immune globulin/hyaluronidase, (hyqvia), 100 mg immuneglobulin |
| J3470 | Injection, hyaluronidase, up to 150 units |
| J3471 | Injection, hyaluronidase, ovine, preservative free, per 1 usp unit (up to 999 usp units) |
| J3472 | Injection, hyaluronidase, ovine, preservative free, per 1000 usp units |
| J3473 | Injection, hyaluronidase, recombinant, 1 usp unit |
| J9144 | Injection, daratumumab, 10 mg and hyaluronidase-fihj |
| J9311 | Injection, rituximab 10 mg and hyaluronidase |
| J9316 | Injection, pertuzumab, trastuzumab, and hyaluronidase-zzxf, per 10 mg |
| J9356 | Injection, trastuzumab, 10 mg and hyaluronidase-oysk |
Clinical
Clinical Trials
258 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 12 | — | — | 2 | — | 14 |
| Dehydration | D003681 | — | E86.0 | 1 | 1 | 1 | 6 | 1 | 10 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 3 | 3 | — | 3 | — | 9 |
| Primary immunodeficiency diseases | D000081207 | — | — | 1 | 2 | 4 | 1 | 3 | 9 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 2 | 2 | 1 | 5 |
| Cataract | D002386 | HP_0000518 | H26.9 | — | — | — | 1 | 1 | 2 |
| Strabismus | D013285 | HP_0000486 | H50.2 | — | — | — | 1 | — | 1 |
| Injection site reaction | D000075662 | — | — | — | — | — | 1 | — | 1 |
| Anesthesia | D000758 | — | — | — | — | — | 1 | — | 1 |
| Pigmentation | D010858 | CHEBI_26130 | — | — | — | — | 1 | — | 1 |
Show 7 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 13 | 10 | 7 | — | — | 27 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 10 | 6 | — | — | 18 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 1 | 3 | — | — | 6 |
| Postoperative pain | D010149 | — | G89.18 | — | 1 | 1 | — | 4 | 5 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | 1 | 1 | — | — | 3 |
| Diabetic retinopathy | D003930 | EFO_0003770 | — | — | 1 | 2 | — | — | 3 |
| Chronic inflammatory demyelinating polyradiculoneuropathy | D020277 | EFO_1000868 | G61.81 | — | — | 2 | — | — | 2 |
| Vitreous hemorrhage | D014823 | EFO_0008626 | H43.1 | — | — | 2 | — | — | 2 |
| Smoldering multiple myeloma | D000075122 | — | — | — | — | 1 | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | — | — | 1 | — | — | 1 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 6 | 5 | — | — | — | 9 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 5 | 6 | — | — | — | 9 |
| Follicular lymphoma | D008224 | — | C82 | 2 | 4 | — | — | — | 5 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 2 | 2 | — | — | — | 4 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 3 | 3 | — | — | — | 4 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | — | 2 | — | — | — | 2 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 2 | 1 | — | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 2 | — | — | — | 2 |
| Melanoma | D008545 | — | — | — | 2 | — | — | — | 2 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | — | 2 | — | — | — | 2 |
Show 19 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 3 | — | — | — | — | 3 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | 2 | — | — | — | — | 2 |
| Microstomia | D008865 | HP_0000160 | Q18.5 | 2 | — | — | — | — | 2 |
| Drug hypersensitivity | D004342 | EFO_0009482 | T88.7 | 2 | — | — | — | — | 2 |
| Neuralgia | D009437 | EFO_0009430 | — | 2 | — | — | — | — | 2 |
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Familial dysautonomia | D004402 | Orphanet_1764 | G90.1 | 1 | — | — | — | — | 1 |
| Burkitt lymphoma | D002051 | — | C83.7 | 1 | — | — | — | — | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 1 | — | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 4 | 4 |
| Infertility | D007246 | HP_0000789 | — | — | — | — | — | 3 | 3 |
| Chronic pain | D059350 | HP_0012532 | — | — | — | — | — | 2 | 2 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 2 | 2 |
| Glaucoma | D005901 | EFO_0000516 | H40 | — | — | — | — | 1 | 1 |
| Failed back surgery syndrome | D055111 | — | — | — | — | — | — | 1 | 1 |
| Stiff-person syndrome | D016750 | EFO_0007498 | G25.82 | — | — | — | — | 1 | 1 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
| Intraocular pressure | D007429 | — | — | — | — | — | — | 1 | 1 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | — | — | 1 | 1 |
Show 9 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Hyaluronidase |
| INN | — |
| Description | Hyaluronidases are a family of enzymes that catalyse the degradation of hyaluronic acid. Karl Meyer classified these enzymes in 1971, into three distinct groups, a scheme based on the enzyme reaction products. The three main types of hyaluronidases are two classes of eukaryotic endoglycosidase hydrolases and a prokaryotic lyase-type of glycosidase.
|
| Classification | Enzyme |
| Drug class | enzymes |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 1FCQ, 1FCU, 1FCV, 1I8Q, 1LOH, 1LXK, 1LXM, 1N7N, 1N7O, 1N7P, 1N7Q, 1N7R, 1OJM, 1OJN, 1OJO, 1OJP, 1W3Y, 2ATM, 2BRP, 2BRV, 2BRW, 2C3F, 2CBI, 2CBJ, 2DP5, 2J1A, 2J1E, 2J62, 2J7M, 2J88, 2JNK, 2OZN, 2PE4, 2WB3, 2WDB, 2WH7, 2YVV, 2YW0, 2YX2, 3EKA, 4D0Q, 4UFQ, 5DIY, 6WV2, 6WWX, 6WXA, 6X3M, 7EYO, 8C6I, 8FNX, 8G0O |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201636 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB00070 |
| UNII ID | — |
Target
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Variants
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Financial
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Phesgo – Roche
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Estimated US medical usage
Hyaluronidase
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 37,613 documents
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Safety
Black-box Warning
Black-box warning for: Herceptin hylecta, Phesgo, Rituxan hycela
Adverse Events
Top Adverse Reactions
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5,390 adverse events reported
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