HYLENEX RECOMBINANT (hyaluronidase recombinant human)
Hylenex Recombinant is an endoglycosidase used as an adjuvant to improve the delivery and absorption of other substances. It is indicated for subcutaneous fluid administration to achieve hydration and to increase the dispersion of other injected medications. Additionally, the drug is used in subcutaneous urography to improve the resorption of radiopaque agents. It functions as a facilitating agent rather than a primary treatment for a specific disease.
How HYLENEX RECOMBINANT Works
This drug works as a dispersion agent by modifying the permeability of connective tissue through the hydrolysis of hyaluronic acid. Hyaluronic acid is a major component of the intercellular ground substance that holds cells together. By splitting the bonds within this acid, the enzyme temporarily decreases the viscosity of the cellular cement. This process facilitates the spread and absorption of injected fluids or localized exudates throughout the tissue.
Details
- Status
- Prescription
- First Approved
- 2005-12-02
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
HYLENEX RECOMBINANT Approval History
What HYLENEX RECOMBINANT Treats
1 indicationsHYLENEX RECOMBINANT is approved for 1 conditions since its original approval in 2005. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dehydration
HYLENEX RECOMBINANT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
HYLENEX RECOMBINANT FDA Label Details
Indications & Usage
FDA Label (PDF)HYLENEX RECOMBINANT is indicated for the treatment of Dehydration.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.