TheraRadar
Data updated: May 26, 2026

CONTEPO (fosfomycin disodium)

Trial Activity: Declining
Infectious Disease Approved 2025-10-22

Contepo is an antibacterial medication used for adults who have complicated urinary tract infections. It also helps patients with acute pyelonephritis, specifically when these infections are caused by E. coli or K. pneumoniae. To help prevent the development of drug-resistant bacteria, clinicians use this drug only when an infection is proven or strongly suspected to be bacterial.

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

How CONTEPO Works

Contepo works as an epoxide antibacterial drug. It targets specific susceptible bacteria, such as Escherichia coli and Klebsiella pneumoniae, to clear the infection.

Source: FDA Label

Development Insights

National Institute of Allergy and Infectious Diseases (NIAID) conducting 2 trials (67%)
6 indications explored (Moderate)
→ bacterial infection (1 trials)
→ multiple-drug resistance (1 trials)
→ pathogen resistance (1 trials)
1
Indication
--
Phase 3 Trials
1
Priority Reviews
0
Years on Market

Details

Status
Prescription
First Approved
2025-10-22
Patent Cliff
2039

Pro Metrics

Patent cliff and revenue data

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Routes
INTRAVENOUS
Dosage Forms
POWDER

Companies

MEITHEAL
Active Ingredient: FOSFOMYCIN DISODIUM

CONTEPO Approval History

2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
Oct 2025 ORIGINAL Priority
New Ingredient · Type 2 - New Active Ingredient
FDA Letter Label

What CONTEPO Treats

2 indications

CONTEPO is approved for 2 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Complicated Urinary Tract Infection
  • Acute Pyelonephritis
Source: FDA Label

CONTEPO Competitive Set

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

Indication competitors

10

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

BLUJEPA
GSK
2025 2 indic.
ORLYNVAH
ITERUM THERAP
2024 1 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 CONTEPO

3 of 4

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

FETROJA
CEFIDEROCOL SULFATE TOSYLATE
1 shared
SHIONOGI
Shared indications:
Complicated Urinary Tract Infection
RECARBRIO
CILASTATIN SODIUM
1 shared
Merck
Shared indications:
Complicated Urinary Tract Infection
VABOMERE
MEROPENEM
1 shared
REMPEX
Shared indications:
Complicated Urinary Tract Infection
View all 4 similar drugs Pro
📋

Clinical Trial Registry

3 trials
Trial Sponsor ID Phase Status Title
NCT03910673 results posted 16-0058 HHSN272201300017I Ph 1 completed Intravenous Fosfomycin Pharmacokinetics Study
NCT03235947 PERIFOS 1649 Ph 4 completed Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients
NCT02178254 13-0064 HHSN272201500005I Ph 1 completed Safety, Tolerability and PK 3-Period Crossover Study Comparing 2 Single Doses of ZTI-01 and Monurol® in Healthy Subjects
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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.

CONTEPO FDA Label Details

Indications & Usage

FDA Label (PDF)

CONTEPO is indicated for the treatment of Complicated Urinary Tract Infection; Acute Pyelonephritis.

View full patent landscape →
3 OB patents · 2 families · 19 international docs across 9 countries

CONTEPO Patents & Exclusivity

Latest Patent: Jan 2039
Exclusivity: Oct 2033

Patents (3 active)

US11541064 Expires Jan 30, 2039
US9345717 Expires Oct 27, 2034
US10086006 Expires Oct 12, 2034

Exclusivity

NP Until Oct 2028
GAIN Until Oct 2033
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for CONTEPO

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2039
  • • 3 active patents

Trial Analysis

  • • 3 total trials
  • • Stage: Declining

Competitive Landscape

  • • 4 similar drugs
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA212271 → 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