hyaluronidase (human recombinant)
Trade name: Hylenex
Recombinant proteinapproved
Approved
Dec 2, 2005
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. — Wikipedia
Clinical trial activity
159 trials · 104 clinical orgs · 6 marketing orgs
Phase 1
65
Phase 2
77
Phase 3
30
Phase 4
12
Earliest trial started Nov 1, 2005 (NCT00311519)
Timeline
2000s
- Dec 2, 2005
Halozyme Therapeutics — Earliest FDA Approval
- Dec 2, 2005
Halozyme Therapeutics — NDA Secondary Org
- Dec 2, 2005
Halozyme Therapeutics — NDA Organization
- Jan 1, 2006
Halozyme Therapeutics — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2006
Halozyme Therapeutics — Earliest Phase 3 Sponsor(trial)
- Jan 1, 2008
Halozyme Therapeutics — Earliest Phase 2 Sponsor(trial)
2010s
2020s
- May 1, 2020
Johnson and Johnson — Marketing Organization
- May 1, 2020
Johnson and Johnson — NDA Secondary Org
- Jun 20, 2023
argenx — Marketing Organization
- Jun 20, 2023
argenx — NDA Secondary Org
Indications
Approved for
Studied for
- Alzheimer Disease · Phase 1
- Amyloidosis · Phase 2
- Anemia, Aplastic · Early Phase 1
- Anemia, Hemolytic · Phase 1
- Anesthesia and Analgesia · Early Phase 1
- Arthritis, Rheumatoid · Phase 4
- Biological Availability · Phase 1
- Breast Neoplasms · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Pancreatic Ductal · Phase 3
- Carcinoma, Renal Cell · Phase 3
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 2
- CREST Syndrome · Early Phase 1
- Dehydration · Phase 4
- Dermal Fillers · Phase 1
- Dermatitis, Allergic Contact · Phase 2
- Diabetes Mellitus · Phase 1
- Diabetes Mellitus, Type 1 · Phase 4
- Diabetes Mellitus, Type 2 · Phase 2
- Diagnostic Self Evaluation · Phase 1
- Disaster Medicine · Phase 1
- Edema · Phase 4
- Endometrial Neoplasms · Phase 2/Phase 3
- Esophageal Neoplasms · Phase 1/Phase 2
- Graft Rejection · Phase 2
- Graves Ophthalmopathy · Phase 2
- Healthy Volunteers · Phase 4
- Heart Transplantation · Phase 2
- Hematologic Neoplasms · Early Phase 1
- HIV Antibodies · Phase 1
- HIV Infections · Phase 2
- Hodgkin Disease · Early Phase 1
- Hypercholesterolemia · Phase 1
- Immunoglobulin Light-chain Amyloidosis · Phase 3
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 3
- Leukemia, Monocytic, Acute · Phase 1
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive · Early Phase 1
- Leukemia, Myeloid · Phase 1
- Leukemia, Myeloid, Acute · Phase 1
- Lung Neoplasms · Phase 2
- Lymphedema · Phase 1/Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 1/Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 1/Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 3
- Lymphoma, Mantle-Cell · Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 3
- Melanoma · Phase 3
- Microstomia · Early Phase 1
- Monoclonal Gammopathy of Undetermined Significance · Phase 2
- Multiple Myeloma · Phase 3
- Multiple Sclerosis · Phase 1
- Muscle Spasticity · Phase 2
- Myelodysplastic Syndromes · Early Phase 1
- Neoplasms · Phase 2
- Neoplasms by Site · Phase 1/Phase 2
- Nerve Degeneration · Phase 3
- Osteoporosis · Phase 1
- Ovarian Neoplasms · Phase 2
- Pain · Phase 4
- Pancreatic Neoplasms · Phase 2
- Peripheral Nervous System Diseases · Phase 2
- Polyradiculoneuropathy · Phase 3
- Polyradiculoneuropathy, Chronic Inflammatory Demyelinating · Phase 3
- Postoperative Pain · Phase 2/Phase 3
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Early Phase 1
- Precursor T-Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Primary Immunodeficiency Diseases · Phase 3
- Primary Myelofibrosis · Early Phase 1
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Psoriasis · Phase 2
- Sarcoma · Phase 2
- Scleroderma, Localized · Early Phase 1
- Scleroderma, Systemic · Early Phase 1
- Scleromyxedema · Early Phase 1
- Shoulder Injuries · Phase 3
- Smoldering Multiple Myeloma · Phase 3
- Surgical Wound Infection · Phase 4
- Therapeutic Equivalency · Phase 1
- Trismus · Phase 4
- Urinary Bladder Neoplasms · Phase 1/Phase 2
- Uterine Neoplasms · Phase 2/Phase 3
- Venous Cutdown · Phase 1
- Vision, Ocular · Phase 4
Mechanism of action
- HyaluronidaseAGONIST
Hyaluronidase agonist
- Hyaluronic acidHYDROLYTIC ENZYME
Hyaluronic acid hydrolytic enzyme
Tissue permeability modifier
Combination products
rituxan hycela
with rituximab
Also known as rituximab and hyaluronidase human
vyvgart hytrulo
with efgartigimod
Also known as efgartigimod alfa and hyaluronidase-qvfc
Approval history
- approvedDec 2, 2005
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaHyaluronidase ↗
- NCATS8KOG53Z5EM ↗
- ChEMBLCHEMBL3989976 ↗
- ChEMBLCHEMBL1201718 ↗
- NCATS743QUY4VD8 ↗
Also known as
- cumulase
- human hyaluronidase
- hyaluronidase, human
- hyaluronidase (human recombinant)
- hyaluronidase (human recombinant)
- hyaluronidase human recombinant
- hyaluronidase recombinant human
- hyaluronidase recombinant human
- hyaluronidase recombinant human
- hylenex
- hylenex
- hylenex recombinant
- pegylated recombinant human hyaluronidase
- recombinant human hyaluronidase
- recombinant human hyaluronidase
- rhuph20
- rhuph20
- vorhyaluronidase alfa
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07220187 | Phase 3 | May 2, 2026 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07247097 | Phase 2 | Apr 15, 2026 | Harvard University, Pfizer |
| NCT07299955 | Phase 1 | Jan 9, 2026 | Biocon Limited |
| NCT06854380 | Early Phase 1 (Phase 1) | Jan 1, 2026 | Mansoura University |
| NCT07298746 | N/A | Dec 31, 2025 | Sohag University |
| NCT07042295 | Phase 2 | Dec 22, 2025 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT07110844 | Phase 2 | Nov 7, 2025 | Columbia University, Janssen Pharmaceutica NV |
| NCT07161414 | Phase 1 | Oct 21, 2025 | AstraZeneca, Parexel |
| NCT07085728 | Phase 2 | Aug 11, 2025 | Eastern Cooperative Oncology Group, ECOG-ACRIN Cancer Research Group, National Cancer Institute (NCI) |
| NCT06980363 | Phase 1 | Jun 1, 2025 | Fayoum University |
| NCT06747351 | Phase 3 | Apr 1, 2025 | Takeda |
| NCT06839391 | Early Phase 1 (Phase 1) | Mar 31, 2025 | Benha University |
| NCT06895967 | Phase 1 | Mar 24, 2025 | Takeda |
| NCT06697197 | Phase 1/Phase 2 (Phase 2) | Mar 3, 2025 | Bristol-Myers Squibb |
| NCT06713317 | Phase 1 | Dec 6, 2024 | Huons Co.,Ltd., Seoul National University |
| NCT06439693 | Phase 2 | Nov 30, 2024 | Harvard University, Johns Hopkins University, Translational Breast Cancer Research Consortium |
| NCT06337318 | Phase 3 | Oct 23, 2024 | National Cancer Institute (NCI), SWOG Cancer Research Network |
| NCT06398457 | Early Phase 1 (Phase 1) | Sep 19, 2024 | Johns Hopkins University |
| NCT07141589 | N/A | Aug 25, 2024 | Cairo University |
| NCT05886036 | Phase 2 | Jul 27, 2024 | National Cancer Institute (NCI), University of Texas at Houston |
Showing 20 of 159 trials
Page 1 / 8
Organizations
Research & Development (104)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Halozyme Therapeutics | For profit | 33 | 25 | 4 | 2005 |
| National Cancer Institute (NCI) | Government | 18 | 6 | 3 | 2013 |
| Baxalta | For profit | 14 | 9 | 5 | 2006 |
| Roche | For profit | 10 | 6 | 3 | 2017 |
| Bristol-Myers Squibb | For profit | 9 | 9 | 3 | 2018 |
| Janssen Pharmaceutica NV | For profit | 9 | 3 | 4 | 2017 |
| Takeda | For profit | 7 | 7 | 3 | 2021 |
| Profil GmbH | For profit | 6 | 0 | 3 | 2008 |
| Genentech | For profit | 5 | 2 | 2 | 2019 |
| Harvard University | Academic/Hospital | 5 | 5 | 2 | 2009 |
| SWOG Cancer Research Network | Academic/Hospital | 5 | 3 | 2 | 2023 |
| Cairo University | Academic/Hospital | 4 | 4 | 3 | 2015 |
| Johnson and Johnson | For profit | 4 | 4 | 2 | 2015 |
| ViiV Healthcare | For profit | 4 | 4 | 2 | 2022 |
| Academic and Community Cancer Research United | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Alexion | For profit | 2 | 2 | 1 | 2018 |
| argenx | For profit | 2 | 2 | 1 | 2019 |
| Assiut University | Academic/Hospital | 2 | 2 | 1 | 2017 |
| AstraZeneca | For profit | 2 | 1 | 1 | 2022 |
| Benha University | Academic/Hospital | 2 | 2 | 2 | 2022 |
104 organizations
Page 1 / 6
Marketing (9)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Genentech | For profit | MKTG | Jun 22, 2017 |
| Halozyme Therapeutics | For profit | NDA2 | Dec 2, 2005 |
| Halozyme Therapeutics | For profit | NDA | Dec 2, 2005 |
| Johnson and Johnson | For profit | MKTG | May 1, 2020 |
| Johnson and Johnson | For profit | NDA2 | May 1, 2020 |
| Roche | For profit | NDA2 | Jun 22, 2017 |
| Takeda | For profit | NDA2 | Sep 12, 2014 |
| argenx | For profit | MKTG | Jun 20, 2023 |
| argenx | For profit | NDA2 | Jun 20, 2023 |