TheraRadar
Data updated: May 26, 2026

THERMAZENE (silver sulfadiazine)

Trial Activity: Mature
Infectious Disease Approved 1985-12-23

THERMAZENE is indicated for the treatment of Wound Sepsis; Burns.

Source: FDA Label • THEPHARMANETWORK LLC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

J. Peter Rubin, MD conducting 1 trials (33%)
3 indications explored (Focused)
→ superficial partial thickness burn (1 trials)
→ second-degree burn (1 trials)
→ burn (1 trials)
1
Indication
--
Phase 3 Trials
40
Years on Market

Details

Status
Prescription
First Approved
1985-12-23
Routes
TOPICAL
Dosage Forms
CREAM

Companies

THEPHARMANETWORK LLC
Active Ingredient: SILVER SULFADIAZINE

THERMAZENE Approval History

1986
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2000
2001
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Original
New Indication
New Form
Label Update
13 FDA actions from 1985 to 2016
Aug 2016 SUPPL
Mfg · Manufacturing (CMC)
Nov 2012 SUPPL
Mfg · Manufacturing (CMC)
Sep 2001 SUPPL
Mfg · Manufacturing (CMC)

What THERMAZENE Treats

2 indications

THERMAZENE is approved for 2 conditions since its original approval in 1985. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Wound Sepsis
  • Burns
Source: FDA Label

THERMAZENE Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

EPIOXA HD/EPIOXA KIT
GLAUKOS
2025 4 indic.
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA
GLAUKOS
2016 4 indic.
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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 THERMAZENE

3 of 6

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

EPIOXA HD/EPIOXA KIT
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Burns
OPTISON
ALBUMIN HUMAN
1 shared
GE HEALTHCARE
Shared indications:
Burns
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Burns
View all 6 similar drugs Pro
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT04601532 results posted STUDY20050205 Ph 4 terminated Superficial Partial-Thickness Burn Study
NCT02108535 ARGENTUM UNISO-2012 Ph 4 completed Comparative Analysis of Cost-effectiveness of Silver Dressing in Burns
NCT01926392 15603 Ph 4 completed Comparison of a Water-soluble Topical Antimicrobial to Silver Sulfadiazine in Partial Thickness Burns
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

THERMAZENE FDA Label Details

Indications & Usage

THERMAZENE is indicated for the treatment of Wound Sepsis; Burns.

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Data Sources

FDA Approval: NDA018810 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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