Hyaluronidase (human recombinant)
Highest phase reached
Approved
Drug type
Enzyme
First approval year
2005
- First approval year
- 2005
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Enzyme
- Drug name
- Hyaluronidase (human recombinant)
- cumulase
- Cumulase
- Hyaluronidase (human recombinant) component of lispro-ph20 rhuph20
- hyaluronidase human recombinant component of lispro ph20 rhuph20
- hylenex
- Hylenex
- hylenex recombinant
- Hylenex recombinant
- 36 482 hyaluronoglucosaminidase ph20 human recombinant
- 36-482-HYALURONOGLUCOSAMINIDASE PH20 (HUMAN) RECOMBINANT
- amivantamab co formulato con ialuronidasi umana ricombinante rhuph20
- argx 113 with rhuph20
- chemophase
- Chemophase
- Commercial Hylenex® recombinant (hyaluronidase human injection)
- DARZALEX FASPRO COMPONENT HYALURONIDASE (HUMAN RECOMBINANT)
- darzalex faspro component hyaluronidase human recombinant
- enhanze
- Enhanze
- ENHANZE (rHuPH20)
- HERCEPTIN HYLECTA COMPONENT HYALURONIDASE (HUMAN RECOMBINANT)
- herceptin hylecta component hyaluronidase human recombinant
- human hyaluronidase
- Human hyaluronidase
- Hyaluronidase (human recombinant)
- HYALURONIDASE (HUMAN RECOMBINANT) [USAN]
- Hyaluronidase (human)
- HYALURONIDASE 1 (HUMAN SPERM SURFACE PROTEIN PH-20)-(1-447)PEPTIDE RECOMBINANT
- hyaluronidase 1 human sperm surface protein ph 20 1 447 peptide recombinant
- hyaluronidase fihj
- Hyaluronidase fihj
- Hyaluronidase fihj [WHO-DD]
- hyaluronidase fihj who dd
And 80 more, listed on the interactive page.
- CAS registry numbers
- 757971-58-7
- ChEMBL ID
- CHEMBL1201718
- RxNorm IDs (RxCUI)
- 1300478
- FDA ingredient codes (UNII)
- 743QUY4VD8
- Applicant
- HALOZYME THERAP
- Approval date
- 2 Dec 2005
- Application number
- BLA021859
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -ase
Administration routes
- Parenteral
Mechanisms of action
- Mechanism
- Hyaluronic acid hydrolytic enzyme
- Action type
- HYDROLYTIC_ENZYME
- Target
- Hyaluronic acid
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Psoriasis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000676
- Subject identifier
- D011565
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001378
- Subject identifier
- D009101
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Smoldering Multiple Myeloma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003073
- Subject identifier
- D000075122
- Condition
- Pain
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003843
- Subject identifier
- D010146
- Condition
- Osteoporosis
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003882
- Subject identifier
- D010024
- Condition
- Dermatitis, Allergic Contact
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000668
- Subject identifier
- D017449
- Condition
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000868
- Subject identifier
- D020277
- Condition
- Hypercholesterolemia
- Highest recorded phase
- 1
- Condition identifier
- HP:0003124
- Subject identifier
- D006937
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0001187
- Subject identifier
- D001749
- Condition
- Primary Immunodeficiency Diseases
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0003778
- Subject identifier
- D000081207
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Diabetes Mellitus, Type 2
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005148
- Subject identifier
- D003924
- Condition
- Multiple Sclerosis
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0005301
- Subject identifier
- D009103
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Angioedemas, Hereditary
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0019623
- Subject identifier
- D054179
- Condition identifier
- EFO_0000349
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000400
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000676
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003073
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003882
- Highest recorded phase
- 1
- Condition identifier
- EFO_1000668
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000868
- Highest recorded phase
- 3
- Condition identifier
- HP_0003124
- Highest recorded phase
- 1
- Condition identifier
- HP_0004313
- Condition identifier
- HP_0004313
- Highest recorded phase
- 4
- Condition identifier
- HP_0012531
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0001187
- Condition identifier
- MONDO_0003778
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005015
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005086
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005148
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005235
- Highest recorded phase
- 3
And 13 more, listed on the interactive page.
- Event
- acute macular neuroretinopathy
- Reports
- 3
- Reporting signal score
- 17.0353
- Event
- administration related reaction
- Reports
- 10
- Reporting signal score
- 53.8972
- Event
- administration site pain
- Reports
- 37
- Reporting signal score
- 186.901
- Event
- administration site reaction
- Reports
- 27
- Reporting signal score
- 146.13
- Event
- cellulitis orbital
- Reports
- 8
- Reporting signal score
- 29.8905
- Event
- conjunctival oedema
- Reports
- 14
- Reporting signal score
- 51.486
- Event
- diarrhoea
- Reports
- 105
- Reporting signal score
- 22.49
- Event
- dilated cardiomyopathy
- Reports
- 4
- Reporting signal score
- 17.5037
- Event
- erythema
- Reports
- 92
- Reporting signal score
- 98.462
- Event
- exophthalmos
- Reports
- 12
- Reporting signal score
- 37.9874
- Event
- infusion related reaction
- Reports
- 41
- Reporting signal score
- 40.571
- Event
- injection site pain
- Reports
- 151
- Reporting signal score
- 184.255
- Event
- injection site reaction
- Reports
- 157
- Reporting signal score
- 337.463
- Event
- lagophthalmos
- Reports
- 19
- Reporting signal score
- 91.8391
- Event
- myopathy toxic
- Reports
- 10
- Reporting signal score
- 37.9385
- Event
- pain
- Reports
- 123
- Reporting signal score
- 65.4864
- Event
- parophthalmia
- Reports
- 17
- Reporting signal score
- 85.0062
- Event
- product dose omission issue
- Reports
- 26
- Reporting signal score
- 20.2944
- Event
- rash
- Reports
- 79
- Reporting signal score
- 18.0835
- Event
- strabismus
- Reports
- 11
- Reporting signal score
- 29.3966
- NCT00318643
- NCT00782587
- NCT00593281
- NCT00705536
- NCT00862849
- NCT00774800
- NCT00883558
- NCT01194245
- NCT01275131
- NCT01945099
- NCT00782106
- NCT00814320
- NCT01175213
- NCT01485796
- NCT05150340
- NCT05513586
- NCT00807963
- NCT00916357
- NCT01194258
- NCT00928447
- NCT01426763
- NCT01756157
- NCT01987609
- NCT02346370
- NCT03735121
And 26 more, listed on the interactive page.
- Dose
- 1,000 mg / 10,000 units (prefilled syringe), 1,008 mg / 11,200 units (vial)
- Route
- Subcutaneous
- How often
- Once weekly for 4 weeks
- Do not inject into irritated, red, bruised, infected, tender, or hard areas, or into moles or scars
- Inject into the abdomen (at least 2 inches from navel)
- Inject subcutaneously over 20-30 seconds (prefilled syringe) or 30-90 seconds (vial)
- Rotate injection sites
- Take out of refrigerator at least 15 minutes before injection for vial
- Take out of refrigerator at least 30 minutes before injection for prefilled syringe
- Use a safety needle for prefilled syringe
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0003-3120
- 0003-6120
- 18657-117
- 50242-077
- 50242-108
- 50242-109
- 50242-245
- 50242-260
- 50242-554
- 50242-933
- 57894-503
- 57894-510
- 57894-514
- 57894-515
- 57894-522
- 51662-1555
- 73475-1221
- 73475-3102
Related records
Trials (130)
- A Pharmacokinetic and Glucodynamic Study of Subcutaneously Administered Insulin Analogs With rHuPH20 Compared to Insulin Analogs Alone
- A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab
- A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects
- A Physiological Study on Downregulation of EGF-receptors in the Skin by Topical Exposition With EGF
- A Safety Study of Human Cord Blood Derived, Culture Expanded Natural Killer Cell (PNK-007) Infusion With Subcutaneous Recombinant Human IL-2 (rhIL-2) in Adults With Relapsed and/or Refractory Acute Myeloid Leukemia (AML)
- A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN)
- A Study Comparing the Safety, Tolerability, and Pharmacokinetics of Sabirnetug IV and Sabirnetug + rHuPH20 SC in Healthy Participants
- A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response
- A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types
- A Study of BMS-986482 Alone or as Combination Therapy in Participants With Advanced Solid Tumors
- A Study of Daratumumab With the Addition of Recombinant Human Hyaluronidase (rHuPH20) for the Treatment of Participants With Relapsed or Refractory Multiple Myeloma
- A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer
- A Study of Nivolumab Intravenous (IV) to Subcutaneous (SC) Switch in Adjuvant Melanoma and Bladder Cancer
- A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma
- A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma
- A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)
- A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread
- A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)
- A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer.
- A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
In development for (20)
- Allergic contact dermatitis Phase 2
- Breast cancer Phase 2
- Cancer Phase 1
- Chronic inflammatory demyelinating polyradiculoneuropathy Phase 3
- Clear cell renal carcinoma Phase 3
- Diabetes mellitus Phase 1
- Hereditary angioedema Phase 2
- HIV infectious disease Phase 2
- Inborn error of immunity Phase 3
- Melanoma Phase 3
- Multiple sclerosis Phase 1
- Neoplasm Phase 1
- Non-small cell lung carcinoma Phase 3
- Osteoporosis Phase 1
- Plasma cell myeloma Phase 3
- Psoriasis Phase 2
- Smoldering plasma cell myeloma Phase 3
- Type 1 diabetes mellitus Phase 2
- Type 2 diabetes mellitus Phase 2
- Urinary bladder cancer Phase 1
Other linked conditions (1)
- Agammaglobulinemia