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
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-54767414 (Daratumumab) in Healthy Participants
- First Posted Date
- 2017-10-25
- Last Posted Date
- 2025-02-03
- Lead Sponsor
- Janssen Research & Development, LLC
- Target Recruit Count
- 66
- Registration Number
- NCT03320707
- Locations
- 🇺🇸
Celerion, Tempe, Arizona, United States
HyQvia in Multifocal Motor Neuropathy
- First Posted Date
- 2016-08-31
- Last Posted Date
- 2016-08-31
- Lead Sponsor
- UMC Utrecht
- Target Recruit Count
- 20
- Registration Number
- NCT02885259
- Locations
- 🇳🇱
UMCU, Utrecht, Utrechts, Netherlands
The Use of a Recombinant DNA-based Hyaluronidase to Dissolve Fixed Amounts of Hyaluronic Acid Dermal Fillers
- First Posted Date
- 2016-01-13
- Last Posted Date
- 2017-05-16
- Lead Sponsor
- Steve Yoelin M.D. Medical Associates, Inc.
- Target Recruit Count
- 15
- Registration Number
- NCT02654522
IVIG Treatment for Asthmatic Patients With IgG Subclass Deficiency
- First Posted Date
- 2013-11-25
- Last Posted Date
- 2016-05-02
- Lead Sponsor
- Ajou University School of Medicine
- Target Recruit Count
- 30
- Registration Number
- NCT01992328
Effects of Subcutaneous Hyaluronidase Administration on Psoriatic Plaques
- First Posted Date
- 2013-11-19
- Last Posted Date
- 2019-01-04
- Lead Sponsor
- Tissa Hata, MD
- Target Recruit Count
- 7
- Registration Number
- NCT01987609
- Locations
- 🇺🇸
UCSD Division of Dermatology, San Diego, California, United States
Descriptive Study of Cardiac Output During Rehydration With Recombinant Human Hyaluronidase in Pediatrics
- First Posted Date
- 2010-06-08
- Last Posted Date
- 2018-02-01
- Lead Sponsor
- Vanderbilt University Medical Center
- Target Recruit Count
- 17
- Registration Number
- NCT01139294
- Locations
- 🇺🇸
Monroe Carell Jr. Children's Hospital at Vanderbilt, Nashville, Tennessee, United States
Study of the Intradermal Injection of rHuPH20 or Placebo in Participants With Nickel Allergic Contact Dermatitis
- First Posted Date
- 2009-06-26
- Last Posted Date
- 2021-12-17
- Lead Sponsor
- Halozyme Therapeutics
- Target Recruit Count
- 22
- Registration Number
- NCT00928447
- Locations
- 🇺🇸
Symbio Phase I Unit, Saint Anthony Memorial Research Center, Michigan City, Indiana, United States
Pharmacokinetic and Glucodynamic Crossover Study of Subcutaneously (SC) Administered Insulin Lispro + Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin + rHuPH20 Compared to Insulin Lispro Alone
- Conditions
- Diabetes Mellitus
- Interventions
- First Posted Date
- 2009-03-17
- Last Posted Date
- 2014-07-22
- Lead Sponsor
- Halozyme Therapeutics
- Target Recruit Count
- 22
- Registration Number
- NCT00862849
- Locations
- 🇺🇸
Profil Institute for Clinical Research, Inc., Chula Vista, California, United States
Pharmacokinetic, Safety and Tolerability Study of SC Administered Bisphosphonate With rHuPH20 vs Bisphosphonate Alone
- Conditions
- Risk Factors for or a Diagnosis of Osteoporosis
- Interventions
- First Posted Date
- 2008-12-15
- Last Posted Date
- 2018-08-15
- Lead Sponsor
- Halozyme Therapeutics
- Target Recruit Count
- 31
- Registration Number
- NCT00807963
- Locations
- 🇺🇸
Healthcare Discoveries, LLC/ICON Development Solutions, San Antonio, Texas, United States
Dose-Ranging, Pharmacokinetic (PK), Glucodynamic (GD), Safety and Tolerability Study of Subcutaneously (SC) Administered Humulin R and Humalog With or Without rHuPH20
- Conditions
- Healthy Volunteers
- Interventions
- First Posted Date
- 2008-12-08
- Last Posted Date
- 2018-08-15
- Lead Sponsor
- Halozyme Therapeutics
- Target Recruit Count
- 42
- Registration Number
- NCT00803972
- Locations
- 🇺🇸
dgd Research, Inc., San Antonio, Texas, United States
Drug Development Updates
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