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Drug ReportsHyaluronidase
Hyaluronidase
Amphadase, Darzalex Faspro, Herceptin Hylecta, Ocrevus Zunovo, Phesgo, Tecentriq Hybreza, 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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Clinical
Drug
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Variants
Financial
Trends
Safety
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5D
1M
3M
6M
YTD
1Y
2Y
5Y
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
Trade Name
FDA
EMA
Amphadase, Vitrase (discontinued: Hydase, Vitrase)
Combinations
Darzalex faspro, Herceptin hylecta, Ocrevus zunovo, Opdivo qvantig, Phesgo, Rybrevant faspro, Tecentriq hybreza, Vyvgart hytrulo
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
Tradename
Proper name
Company
Number
Date
Products
AmphadasehyaluronidaseAmphastar PharmaceuticalsN-21665 RX2004-10-26
1 products
VitrasehyaluronidaseBausch Health CompaniesN-21640 RX2004-12-02
1 products
Show 2 discontinued
Hyaluronidase
+
Trastuzumab
Tradename
Proper name
Company
Number
Date
Products
Herceptin Hylectatrastuzumab and hyaluronidase-oyskGenentechN-761106 RX2019-02-28
1 products
Daratumumab
+
Hyaluronidase
Tradename
Proper name
Company
Number
Date
Products
Darzalex Fasprodaratumumab and hyaluronidase-fihjJohnson & JohnsonN-761145 RX2020-05-01
1 products
Hyaluronidase
+
Pertuzumab
+
Trastuzumab
Tradename
Proper name
Company
Number
Date
Products
Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxfGenentechN-761170 RX2020-06-29
2 products
Efgartigimod alfa
+
Hyaluronidase
Tradename
Proper name
Company
Number
Date
Products
Vyvgart Hytruloefgartigimod alfa and hyaluronidase-qvfcArgenxN-761304 RX2023-06-20
2 products
Atezolizumab
+
Hyaluronidase
Tradename
Proper name
Company
Number
Date
Products
Tecentriq Hybrezaatezolizumab and hyaluronidase-tqjsGenentechN-761347 RX2024-09-12
1 products
Hyaluronidase
+
Ocrelizumab
Tradename
Proper name
Company
Number
Date
Products
Ocrevus Zunovoocrelizumab and hyaluronidase-ocsqGenentechN-761371 RX2024-09-13
1 products
Hyaluronidase
+
Nivolumab
Tradename
Proper name
Company
Number
Date
Products
Opdivo Qvantignivolumab and hyaluronidase-nvhyBristol Myers SquibbN-761381 RX2024-12-27
2 products
Amivantamab
+
Hyaluronidase
Tradename
Proper name
Company
Number
Date
Products
Rybrevant Fasproamivantamab and hyaluronidase-lpujJohnson & JohnsonN-761484 RX2026-02-13
4 products
Labels
FDA
EMA
Brand Name
Status
Last Update
amphadaseBiologic Licensing Application2024-02-01
darzalex fasproBiologic Licensing Application2026-02-11
herceptin hylectaBiologic Licensing Application2025-12-10
hyaluronidaseBiologic Licensing Application2021-06-04
hylenex recombinantBiologic Licensing Application2024-11-11
ocrevus zunovoBiologic Licensing Application2025-12-11
opdivo qvantigBiologic Licensing Application2025-11-24
phesgoBiologic Licensing Application2025-12-05
rituxan hycelaBiologic Licensing Application2025-12-15
rybrevant fasproBiologic Licensing Application2026-02-18
Show 4 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
extravasation of diagnostic and therapeutic materials—D005119—
breast neoplasmsEFO_0003869D001943C50
gastrointestinal neoplasms—D005770C26.9
multiple myeloma—D009101C90.0
non-small-cell lung carcinoma—D002289—
hepatocellular carcinoma—D006528C22.0
urinary bladder neoplasms—D001749C67
melanoma—D008545—
small cell lung carcinoma—D055752—
alveolar soft part sarcoma—D018234—
Show 4 more
Agency Specific
FDA
EMA
Expiration
Code
efgartigimod alfa / hyaluronidase, Vyvgart Hytrulo, Argenx BV
2030-06-20Orphan excl.
daratumumab / hyaluronidase, Darzalex Faspro, Janssen Biotech, Inc.
2028-01-15Orphan excl.
Patent Expiration
No data
ATC Codes
B: Blood and blood forming organ drugs
— B06: Other hematological agents in atc
— B06A: Other hematological agents in atc
— B06AA: Enzymes, hematological
— B06AA03: Hyaluronidase
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
332 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 myelomaD009101—C90.01816121—43
Healthy volunteers/patients———17—12—20
Primary immunodeficiency diseasesD000081207——1381414
DehydrationD003681—E86.01116110
Type 1 diabetes mellitusD003922EFO_0001359E1033—3—9
Immunologic deficiency syndromesD007153—D84.9—15139
Insulin resistanceD007333EFO_0002614E88.81943—1—8
PainD010146EFO_0003843R52——2215
Diabetes mellitusD003920EFO_0000400E08-E132——1—3
CataractD002386EFO_0001059H26.9———123
Show 14 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C504187—128
NeoplasmsD009369—C8011111——18
Plasma cell neoplasmsD054219——765——16
Non-small-cell lung carcinomaD002289——347——14
Follicular lymphomaD008224—C82262——8
B-cell lymphomaD016393——341——6
Postoperative painD010149—G89.18—11—56
Large b-cell lymphoma diffuseD016403—C83.3341——5
LymphomaD008223—C85.9311——5
Immunoglobulin light-chain amyloidosisD000075363———21—25
Show 29 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C2566———10
Non-hodgkin lymphomaD008228—C85.933———6
Neoplasm metastasisD009362EFO_0009708—32——15
RecurrenceD012008——43———5
AmyloidosisD000686EFO_1001875E85—2——24
SyndromeD013577———1——34
Myeloid leukemia acuteD015470—C92.031———3
HypersensitivityD006967EFO_0003785T78.4021———3
Male breast neoplasmsD018567———3———3
Hematologic neoplasmsD019337——22———3
Show 44 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Carpal tunnel syndromeD002349EFO_0004143G56.01———56
Hiv infectionsD015658EFO_0000764B205————5
Chronic painD059350——1———23
NeuralgiaD009437EFO_0009430—2———13
Systemic sclerodermaD012595EFO_0000717M342————2
MicrostomiaD008865—Q18.52————2
Drug hypersensitivityD004342EFO_0009482T88.72————2
CholangiocarcinomaD018281—C22.11————1
Monocytic leukemia acuteD007948——1————1
Myeloid leukemiaD007951—C921————1
Show 30 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfertilityD007246EFO_0000545—————44
Ocular hypotensionD015814—H44.4————22
Failed back surgery syndromeD055111——————22
PeriodontitisD010518EFO_0000649K05.3————22
Wounds and injuriesD014947—T14.8————22
Low back painD017116—M54.5————22
RadiculopathyD011843—M54.1————22
GlaucomaD005901EFO_0000516H40————11
SarcopeniaD055948EFO_1000653M62.84————11
Intermittent claudicationD007383EFO_0003876I73.9————11
Show 29 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameHyaluronidase
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 classenzymes
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB1FCQ, 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 IDCHEMBL1201636
ChEBI ID—
PubChem CID—
DrugBankDB00070
UNII ID—
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
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
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 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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20,334 adverse events reported
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