> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/hyaluronidase-human-recombinant-2ffd4cc0-072b-4151-9944-5ed298381155
> Record changed: 2026-10-13

# Hyaluronidase (human recombinant)

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

Drug type

Enzyme

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

First approval year

2005

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

## Development status

**First approval year**

2005

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

## Names and chemistry

**Drug type**

Enzyme

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

**Drug name**

Hyaluronidase (human recombinant)

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

### Brand names (8)

- cumulase
- Cumulase
- Hyaluronidase (human recombinant) component of lispro-ph20 rhuph20
- hyaluronidase human recombinant component of lispro ph20 rhuph20
- hylenex
- Hylenex
- hylenex recombinant
- Hylenex recombinant

### Other names (105)

- 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.

## Identifiers

**CAS registry numbers**

- 757971-58-7

**ChEMBL ID**

CHEMBL1201718

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1201718)

**RxNorm IDs (RxCUI)**

- 1300478

**FDA ingredient codes (UNII)**

- 743QUY4VD8

## Regulatory information

### United States

**Applicant**

HALOZYME THERAP

**Approval date**

2 Dec 2005

**Application number**

BLA021859

### Other regulatory facts

**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

## Pharmacology

### Drug classification

**Drug name stem**

\-ase

#### Administration routes

- Parenteral

### Mechanisms of action

- **Mechanism**  
Hyaluronic acid hydrolytic enzyme

**Action type**  
HYDROLYTIC\_ENZYME

**Target**  
Hyaluronic acid

### Investigated indications (22)

- **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

### Open Targets indications (38)

- **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.

### Reported adverse events (20)

- **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

### Trial references (51)

- NCT00318643  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00318643)
- NCT00782587  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00782587)
- NCT00593281  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00593281)
- NCT00705536  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00705536)
- NCT00862849  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00862849)
- NCT00774800  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00774800)
- NCT00883558  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00883558)
- NCT01194245  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01194245)
- NCT01275131  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01275131)
- NCT01945099  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01945099)
- NCT00782106  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00782106)
- NCT00814320  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00814320)
- NCT01175213  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01175213)
- NCT01485796  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01485796)
- NCT05150340  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05150340)
- NCT05513586  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05513586)
- NCT00807963  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00807963)
- NCT00916357  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00916357)
- NCT01194258  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01194258)
- NCT00928447  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00928447)
- NCT01426763  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01426763)
- NCT01756157  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01756157)
- NCT01987609  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01987609)
- NCT02346370  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02346370)
- NCT03735121  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03735121)

And 26 more, listed on the interactive page.

## Dosing

**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

### Conditions of use (7)

- 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

## Chemical properties

**Prodrug**

No

**Chirality**

Single enantiomer

**Inorganic**

No

**Natural product**

No

## National Drug Codes

- 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](https://trialight.com/data/trial/a-study-of-bms-986482-alone-or-as-combination-therapy-in-6d77cbe1-5589-468b-b0ee-4b57e5d96643.md)
- 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](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) Phase 2
- [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) Phase 1
- Chronic inflammatory demyelinating polyradiculoneuropathy Phase 3
- [Clear cell renal carcinoma](https://trialight.com/data/condition/clear-cell-renal-carcinoma-789eee25-ec64-5771-9b7d-d19544781b11.md) Phase 3
- [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Phase 1
- Hereditary angioedema Phase 2
- [HIV infectious disease](https://trialight.com/data/condition/hiv-infectious-disease-1260f28c-d667-55f9-b221-15d5017fde05.md) Phase 2
- Inborn error of immunity Phase 3
- [Melanoma](https://trialight.com/data/condition/melanoma-457e9de6-dcd9-56fb-be48-0290fb4386ef.md) Phase 3
- [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) Phase 1
- Neoplasm Phase 1
- [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Phase 3
- Osteoporosis Phase 1
- [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Phase 3
- [Psoriasis](https://trialight.com/data/condition/psoriasis-4340caf0-883c-54c7-886d-31e59b80dead.md) Phase 2
- Smoldering plasma cell myeloma Phase 3
- Type 1 diabetes mellitus Phase 2
- [Type 2 diabetes mellitus](https://trialight.com/data/condition/type-2-diabetes-mellitus-98e14a90-bb06-5174-90c7-901a0a259fb9.md) Phase 2
- Urinary bladder cancer Phase 1

### Other linked conditions (1)

- Agammaglobulinemia

---

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