Hyaluronidase (human recombinant)

Generic Name: Hyaluronidase (human recombinant)

Brand Names: Darzalex Faspro, Herceptin Hylecta, Hylenex, Hyqvia 5 G / 50 Ml Kit, Phesgo, Rituxan Hycela, Vyvgart Hytrulo

Drug Type: Biotech

CAS Number: 757971-58-7

Unique Ingredient Identifier: 743QUY4VD8

Background: A purified preparation of the enzyme recombinant human hyaluronidase. Hyaluronidase (human recombinant) (INN Vorhyaluronidase alfa) is produced by genetically engineered Chinese Hamster Ovary (CHO) cells containing a DNA plasmid encoding for a soluble fragment of human hyaluronidase (PH20). Hyaluronidase is an enzyme used to improve the absorption and dispersion of parenterally administered fluids, drugs, and contrast agents. The action of hyaluronidase was first described in 1936, and named in 1939. Early research into hyaluronidase identified it as a "spreading factor" which allowed for increased permeability of the connective tissue. Hyaluronidase has been used in surgical settings for at least the past 60 years to improve the diffusion of local anesthetics.

Hyaluronidase was first used in prescription products in the United States on 5 May 2004.

Indication: Hyaluronidase is indicated for subcutaneous fluid administration for hydration, and increasing resorption of radiopaque agents in subcutaneous urography. Hyaluronidase is also indicated by multiple routes to increase the dispersion of other injectable drugs.

Associated Conditions: Drug Extravasation, Generalized Myasthenia Gravis, Inflammatory Breast Cancer (IBC), Locally Advanced Breast Cancer (LABC), Metastatic Breast Cancer, Primary Immune Deficiency Disorders (PIDD), Primary Immunodeficiency, Secondary humoral immunodeficiency, Stage I Breast Cancer

Associated Therapies: Parenteral rehydration therapy, Improving resorption of radiopaque agents, To increase percutaneous drug absorption therapy

Clinical Trials

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer

Phase 2

Recruiting

Conditions: HER2-positive Breast Cancer

Interventions: Drug: PHESGO
Drug: Inavolisib
Drug: Endocrine therapy

First Posted Date: 2022-03-31

Last Posted Date: 2025-02-17

Lead Sponsor: German Breast Group

Target Recruit Count: 170

Registration Number: NCT05306041

Locations: 🇩🇪
Hämatologie-Onkologie im Zentrum MVZ GmbH, Augsburg, Germany
🇩🇪
DBZ Onkologie, Berlin, Germany
🇩🇪
Praxisklinik Krebsheilkunde für Frauen, Berlin, Germany

and more 26 locations

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)

Phase 3

Recruiting

Conditions: Locally Advanced or Metastatic Breast Cancer

Interventions: Drug: Phesgo
Drug: Docetaxel
Drug: LHRH Agonist
Drug: Giredestrant
Drug: Paclitaxel
Drug: Optional Endocrine Therapy of Investigator's Choice

First Posted Date: 2022-03-25

Last Posted Date: 2025-04-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 922

Registration Number: NCT05296798

Locations: 🇪🇬
Sohag Oncology Center, Cairo, Egypt
🇧🇪
Clinique Ste-Elisabeth, Namur, Belgium
🇧🇷
Hospital Sao Rafael - HSR, Salvador, Bahia, Brazil

and more 234 locations

dMAbs for Prevention of COVID-19

Phase 1

Active, not recruiting

Conditions: Healthy Volunteers

Interventions: Combination Product: dMAb AZD5396
Combination Product: dMAb AZD8076
Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0078 Electroporation device
Combination Product: CELLECTRA™ 2000 with Side Port needle, OpBlock 0070 Electroporation device
Drug: Hylenex

First Posted Date: 2022-03-24

Last Posted Date: 2024-07-03

Lead Sponsor: Pablo Tebas

Target Recruit Count: 61

Registration Number: NCT05293249

Locations: 🇺🇸
University of Pennsylvania, Philadelphia, Pennsylvania, United States

A Study to Investigate the Safety and Pharmacokinetics of a Single Dose of VH3810109 (Also Known as GSK3810109), Administered Either Subcutaneously (SC) With rHuPH20 or Intravenously (IV), in Healthy Adult Participants

Phase 1

Completed

Conditions: HIV Infections

Interventions: Biological: VH3810109
Biological: rHuPH20

First Posted Date: 2022-03-22

Last Posted Date: 2023-05-11

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 24

Registration Number: NCT05291520

Locations: 🇺🇸
GSK Investigational Site, Austin, Texas, United States

Study of Subcutaneous and Intravenous ALXN1720 With and Without rHuPH20 in Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: ALXN1720 IV
Drug: ALXN1720 SC
Drug: Placebo SC
Drug: Placebo IV
Drug: rHuPH20

First Posted Date: 2021-06-09

Last Posted Date: 2022-02-11

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 97

Registration Number: NCT04920370

Locations: 🇬🇧
Clinical Study Site, London, United Kingdom

A Phase 1, Bioavailability Study of Relatlimab in Combination With Nivolumab

Phase 1

Completed

Conditions: Cancer

Interventions: Drug: relatlimab
Drug: nivolumab
Drug: rHuPH20

First Posted Date: 2019-10-02

Last Posted Date: 2023-04-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 24

Registration Number: NCT04112498

Locations: 🇺🇸
Local Institution - 0001, Hackensack, New Jersey, United States

A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis

Phase 1

Active, not recruiting

Conditions: Multiple Sclerosis (MS)

Interventions: Drug: Ocrelizumab
Drug: rHuPH20

First Posted Date: 2019-06-03

Last Posted Date: 2025-03-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 134

Registration Number: NCT03972306

Locations: 🇺🇸
University of Colorado, Aurora, Colorado, United States
🇺🇸
Georgetown University Medical Center, Washington, District of Columbia, United States
🇺🇸
University of South Florida School of Medicine Morsani Center for Advanced Health Care, Tampa, Florida, United States

and more 17 locations

A Study to Investigate Atezolizumab Subcutaneous in Patients With Previously Treated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3

Completed

Conditions: Non-Small Cell Lung Cancer

Interventions: Drug: Atezolizumab
Drug: rHuPH20

First Posted Date: 2018-11-08

Last Posted Date: 2025-01-24

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 438

Registration Number: NCT03735121

Locations: 🇹🇭
Chulalongkorn Hospital, Bangkok, Thailand
🇹🇭
Rajavithi Hospital, Bangkok, Thailand
🇦🇷
Consultorio Dr. Miguel Angel Escudero, Salta, Argentina

and more 68 locations

A Study of Subcutaneous Nivolumab Monotherapy With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

Phase 1

Completed

Conditions: Neoplasms by Site

Interventions: Biological: nivolumab
Drug: rHuPH20

First Posted Date: 2018-09-04

Last Posted Date: 2025-02-20

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 139

Registration Number: NCT03656718

Locations: 🇺🇸
Local Institution - 0012, Eugene, Oregon, United States
🇺🇸
Greenville Health System, Greenville, South Carolina, United States
🇺🇸
Local Institution - 0011, Tyler, Texas, United States

and more 33 locations

An Investigational Immunotherapy Study of BMS-986258 Alone and in Combination With Nivolumab in Participants With Solid Cancers That Are Advanced or Have Spread

Phase 1

Terminated

Conditions: Advanced Cancer

Interventions: Biological: BMS-986258
Biological: Nivolumab
Drug: rHuPH20

First Posted Date: 2018-02-26

Last Posted Date: 2025-01-20

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 92

Registration Number: NCT03446040

Locations: 🇺🇸
Local Institution - 0012, Lebanon, New Hampshire, United States
🇺🇸
Local Institution - 0007, Aurora, Colorado, United States
🇺🇸
Local Institution - 0016, Cincinnati, Ohio, United States

and more 13 locations

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy