AMPHADASE (hyaluronidase)
Amphadase is an endoglycosidase enzyme used as an adjuvant to facilitate the administration and absorption of fluids and medications. It is indicated for use in subcutaneous fluid administration for hydration and to increase the dispersion of other injected drugs. Additionally, the agent is utilized in subcutaneous urography to improve the resorption of radiopaque agents.
How AMPHADASE Works
Hyaluronidase functions as a dispersion agent by hydrolyzing hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue. By splitting specific glucosaminidic bonds, the enzyme temporarily decreases the viscosity of the cellular cement and increases tissue permeability. This process promotes the dispersion of injected fluids or localized transudates, thereby facilitating their absorption into the body.
Details
- Status
- Prescription
- First Approved
- 2004-10-26
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
AMPHADASE Approval History
What AMPHADASE Treats
1 indicationsAMPHADASE is approved for 1 conditions since its original approval in 2004. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Dehydration
AMPHADASE 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.
Drugs Similar to AMPHADASE
3 of 5FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05498220 results posted | LCCC2033 | Ph 2 | terminated | Polatuzumab Vedotin With R-GDP in Relapsed/Refractory Diffuse Large B-cell Lymphoma |
| NCT03306615 | IRB00273264 | Ph 2 | active not recruiting | Peripheral Modulation of Muscle Stiffness and Spasticity |
| NCT06604546 | SHBJ-KJ017-001 | Ph 3 | completed | Hyaluronidase Assisted Subcutaneous Infusion |
| NCT02199028 results posted | 28949 JDRF 17-2013/471 | Ph 1 | completed | Hyaluronidase Effect on Infusion Set Life |
| NCT01689363 H001-A2 results posted | API-H001-CLN-A2 | Ph 2 | completed | Evaluation of the Allergenicity of AMPHADASE INJECTION (Hyaluronidase Injection USP) |
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.
AMPHADASE FDA Label Details
Indications & Usage
FDA Label (PDF)AMPHADASE 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.