VANCOMYCIN HYDROCHLORIDE · ASPIRO
Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. Vancomycin Hydrochloride for Injection, USP is effective in the treatment of staphylococcal endocarditis. Its effectiveness has been documented in other infections due to staphylococci, including septicemia, bone infections, lower respiratory tract infections, skin and skin structure infections.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1964-11-06
- Routes
- INJECTION, ORAL, INTRAVENOUS, INTRAVENOUS, ORAL
- Dosage Forms
- INJECTABLE, CAPSULE, POWDER, FOR SOLUTION
Companies
VANCOMYCIN HYDROCHLORIDE Approval History
What VANCOMYCIN HYDROCHLORIDE Treats
5 indicationsVANCOMYCIN HYDROCHLORIDE is approved for 5 conditions since its original approval in 1987. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Staphylococcal Endocarditis
- Septicemia
- Bone Infection
- Lower Respiratory Tract Infection
- Skin Infection
VANCOMYCIN HYDROCHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05766670 | W81XWH-22-10937 W81XWH-22-10937 | Ph 3 | recruiting | Intramedullary Calcium Sulfate Antibiotic Depot |
| NCT04500275 | A-BR-109-013 | Ph 4 | completed | Topical Vancomycin Over Sternal Edge in Cardiac Surgery |
| NCT06126614 PREVENT-iT | PiT-2023 | Ph 3 | recruiting | Infection Prophylaxis in Total Joint Replacement |
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.
VANCOMYCIN HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Vancomycin Hydrochloride for Injection, USP is indicated for the treatment of serious or severe infections caused by susceptible strains of methicillin-resistant (β-lactam-resistant) staphylococci. It is indicated for penicillin-allergic patients, for patients who cannot receive or who have failed to respond to other drugs, including the penicillins or cephalosporins, and for infections caused by vancomycin-susceptible organisms that are resistant to other antimicrobial drugs. Vancomycin Hydrochloride for Injection, USP is indicated for initial therapy when methicillin-resistant staphylococci ...
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VANCOCIN HYDROCHLORIDE
Full clinical data, patents, trials, and competitive landscape for vancomycin hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment