Overview
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
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/02/21 | Early Phase 1 | Not yet recruiting | |||
2024/12/05 | Phase 2 | Recruiting | |||
2024/09/19 | Phase 3 | Completed | |||
2024/06/12 | Not Applicable | Recruiting | Yongyong MA | ||
2024/04/19 | Not Applicable | Recruiting | Nanjing University School of Medicine | ||
2023/08/16 | Early Phase 1 | Completed | |||
2023/03/13 | Not Applicable | Completed | |||
2023/03/10 | Not Applicable | Completed | Nakhia Impex LLC | ||
2023/03/06 | Not Applicable | Completed | |||
2023/01/04 | Not Applicable | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Amphastar Pharmaceuticals, Inc. | 0548-9090 | SUBCUTANEOUS | 150 [USP'U] in 1 mL | 5/28/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hyaluronidase for Injection | 国药准字H31022110 | 化学药品 | 注射剂（冻干） | 5/20/2020 | |
| Hyaluronidase for Injection | 国药准字H22026531 | 化学药品 | 注射剂（冻干） | 9/27/2023 | |
| Hyaluronidase for Injection | 国药准字H41022074 | 化学药品 | 注射剂 | 7/15/2020 | |
| Hyaluronidase for Injection | 国药准字H31022111 | 化学药品 | 注射剂（冻干） | 5/22/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hyalase 1500IU powder for injection ampoule | 27749 | Medicine | A | 10/21/1991 |
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