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

The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer

Phase 2

Recruiting

Conditions: Stage IV Breast Cancer
Breast Cancer Metastatic
Breast Cancer Female
Breast Cancer
Estrogen Receptor-positive Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: Nab-Paclitaxel
Drug: Paclitaxel
Drug: Docetaxel
Drug: Phesgo
Drug: T-DM1
Drug: Pertuzumab
Drug: Trastuzumab Deruxtecan
Drug: Trastuzumab Subcutaneous Subcutaneous
Drug: Tucatinib
Drug: Trastuzumab

First Posted Date: 2024-06-03

Last Posted Date: 2025-04-03

Lead Sponsor: Dana-Farber Cancer Institute

Target Recruit Count: 72

Registration Number: NCT06439693

Locations: 🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States

First Time in Human Study of Long Acting VH4524184 Formulations

Phase 1

Recruiting

Conditions: HIV Infections

Interventions: Drug: Oral VH4524184
Drug: VH4524184 Formulation A SC
Drug: VH4524184 Formulation A IM
Drug: VH4524184 Formulation B IM
Drug: Placebo Formulation B IM
Drug: Placebo Formulation A SC
Drug: VH4524184 Formulation B SC
Drug: VH4524184 Formulation C SC
Drug: Placebo Formulation A IM
Drug: rHuPH20
Drug: Placebo Formulation B SC
Drug: Placebo Formulation C SC

First Posted Date: 2024-03-15

Last Posted Date: 2025-02-24

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 72

Registration Number: NCT06310551

Locations: 🇺🇸
GSK Investigational Site, San Antonio, Texas, United States

PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer

Phase 2

Recruiting

Conditions: HER2-positive Breast Cancer

Interventions: Drug: Trastuzumab deruxtecan
Drug: Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection
Drug: Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection

First Posted Date: 2023-12-15

Last Posted Date: 2025-01-22

Lead Sponsor: MedSIR

Target Recruit Count: 165

Registration Number: NCT06172127

Locations: 🇺🇸
Northwell Health, New York, New York, United States
🇩🇪
Klinikum der Universität München, München, Germany
🇮🇹
University Hospital Maggiore della Carita, Novara, Italy

and more 20 locations

Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade

Phase 2

Recruiting

Conditions: Breast Cancer
HER2-positive Breast Cancer

Interventions: Drug: PHESGO

First Posted Date: 2023-10-05

Last Posted Date: 2025-02-05

Lead Sponsor: Latin American Cooperative Oncology Group

Target Recruit Count: 63

Registration Number: NCT06068985

Locations: 🇧🇷
NOB - Núcleo de Oncologia da Bahia (Oncoclínicas), Salvador, Bahia, Brazil
🇧🇷
Oncocentro de Minas Gerais (Oncoclínicas), Belo Horizonte, Minas Gerais, Brazil
🇧🇷
CPO - Centro de Pesquisa em Oncologia do Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, Brazil

and more 4 locations

A Study to Investigate the Virologic Efficacy and Safety of VH3810109 + Cabotegravir Compared to Standard of Care (SOC) in Male and Female Adults Living With Human Immunodeficiency Virus (HIV)

Phase 2

Active, not recruiting

Conditions: HIV Infections

Interventions: Biological: VH3810109
Drug: Standard of care (SOC)
Drug: Cabotegravir
Biological: rHuPH20

First Posted Date: 2023-08-18

Last Posted Date: 2025-04-01

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 135

Registration Number: NCT05996471

Locations: 🇵🇷
GSK Investigational Site, San Juan, Puerto Rico

A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer

Phase 3

Recruiting

Conditions: Metastatic Breast Cancer

Interventions: Drug: Phesgo
Drug: Inavolisib
Drug: Taxane-based Chemotherapy
Drug: Placebo
Drug: Optional Endocrine Therapy of Investigator's Choice

First Posted Date: 2023-06-08

Last Posted Date: 2025-05-09

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 230

Registration Number: NCT05894239

Locations: 🇨🇳
Shandong Cancer Hospital, Jinan, China
🇹🇷
Gazi University Medical Faculty, Ankara, Turkey
🇹🇳
Farhat Hached Hospital, Sousse, Tunisia

and more 161 locations

A Study of Subcutaneous Nivolumab + Relatlimab Fixed-dose Combination (FDC) in Previously Untreated Metastatic or Unresectable Melanoma

Phase 3

Active, not recruiting

Conditions: Melanoma

Interventions: Drug: Nivolumab + Relatlimab
Drug: rHuPH20

First Posted Date: 2022-11-22

Last Posted Date: 2025-03-06

Lead Sponsor: Bristol-Myers Squibb

Target Recruit Count: 570

Registration Number: NCT05625399

Locations: 🇪🇸
Local Institution - 0086, A Coruna, Spain
🇪🇸
Local Institution - 0134, Badalona, Spain
🇪🇸
Local Institution - 0047, Barcelona, Spain

and more 146 locations

A Study to Investigate Pharmacokinetics, Safety and Tolerability of Long-Acting Cabotegravir Plus Recombinant Human Hyaluronidase PH20 in Healthy Adult Participants

Phase 1

Recruiting

Conditions: HIV Infections

Interventions: Drug: RPV
Drug: Cabotegravir 200 mg/mL
Drug: Cabotegravir >=400 mg/mL
Drug: rHuPH20
Drug: Cabotegravir Formulation I

First Posted Date: 2022-06-14

Last Posted Date: 2025-02-19

Lead Sponsor: ViiV Healthcare

Target Recruit Count: 180

Registration Number: NCT05418868

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

Pharmacokinetic Study of Ravulizumab Administered Subcutaneously With Recombinant Human Hyaluronidase PH20 (rHuPH20) in Healthy Adult Volunteers

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ravulizumab
Drug: rHuPH20

First Posted Date: 2022-05-31

Last Posted Date: 2024-01-22

Lead Sponsor: Alexion Pharmaceuticals, Inc.

Target Recruit Count: 49

Registration Number: NCT05396742

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

Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE)

Phase 2

Recruiting

Conditions: Early-stage Breast Cancer

Interventions: Drug: Atezolizumab 1200 mg in 20 ML Injection
Drug: Trastuzumab/pertuzumab
Drug: Ipatasertib
Drug: Olaparib
Drug: Sacituzumab govitecan
Drug: Inavolisib

First Posted Date: 2022-04-18

Last Posted Date: 2025-03-20

Lead Sponsor: German Cancer Research Center

Target Recruit Count: 240

Registration Number: NCT05332561

Locations: 🇩🇪
National Center for Tumor Diseases, Heidelberg, Baden-Wuerttemberg, Germany
🇩🇪
Universitätsklinikum Tübingen, Tübingen, Baden-Württemberg, Germany
🇩🇪
Universitätsklinikum Augsburg, Augsburg, Bayern, Germany

and more 6 locations

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