CLINICAL TRIALS PROFILE FOR PROBENECID; SULOPENEM ETZADROXIL

All Clinical Trials for probenecid; sulopenem etzadroxil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03354598 ↗	Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women	Completed	Iterum Therapeutics, International Limited	Phase 3	2018-08-01	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
NCT03354598 ↗	Oral Sulopenem-etzadroxil/Probenecid Versus Ciprofloxacin for Uncomplicated Urinary Tract Infection in Adult Women	Completed	Iterum Therapeutics, US Limited	Phase 3	2018-08-01	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability, and safety of oral sulopenem-etzadroxil/probenecid versus oral ciprofloxacin for treatment of uncomplicated urinary tract infection (uUTI) in adult women
NCT03357614 ↗	Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults	Completed	Iterum Therapeutics, International Limited	Phase 3	2018-09-18	This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
NCT03357614 ↗	Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults	Completed	Iterum Therapeutics, US Limited	Phase 3	2018-09-18	This is a prospective, phase 3, randomized, multicenter, double-blind, double-dummy study to compare the efficacy and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin for the treatment of complicated urinary tract infections (cUTI) in adults.
NCT03358576 ↗	Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)	Completed	Iterum Therapeutics, International Limited	Phase 3	2018-09-18	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.
NCT03358576 ↗	Sulopenem Versus Ertapenem for Complicated Intra-abdominal Infection (cIAI)	Completed	Iterum Therapeutics, US Limited	Phase 3	2018-09-18	This is a prospective, Phase 3, randomized, multi-center, double-blind study of the efficacy, tolerability and safety of sulopenem followed by sulopenem-etzadroxil/probenecid versus ertapenem followed by ciprofloxacin-metronidazole for treatment of complicated intra-abdominal infections in adults.

Clinical Trial Conditions for probenecid; sulopenem etzadroxil

Condition Name

Condition Name for probenecid; sulopenem etzadroxil
Intervention	Trials
Urinary Tract Infections	4
Antibiotic Resistant Infection	3
Complicated Infection	2
Complicated Urinary Tract Infections	1

Condition MeSH

Condition MeSH for probenecid; sulopenem etzadroxil
Intervention	Trials
Communicable Diseases	5
Urinary Tract Infections	4
Infections	4
Infection	4

Clinical Trial Locations for probenecid; sulopenem etzadroxil

Trials by Country

Trials by Country for probenecid; sulopenem etzadroxil
Location	Trials
United States	49
Hungary	2
Georgia	2
Estonia	2
Latvia	2

Trials by US State

Trials by US State for probenecid; sulopenem etzadroxil
Location	Trials
California	4
Ohio	3
Montana	3
Idaho	3
Texas	3

Clinical Trial Progress for probenecid; sulopenem etzadroxil

Clinical Trial Phase

Clinical Trial Phase for probenecid; sulopenem etzadroxil
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	4
Phase 1	1

Clinical Trial Status

Clinical Trial Status for probenecid; sulopenem etzadroxil
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for probenecid; sulopenem etzadroxil

Sponsor Name

Sponsor Name for probenecid; sulopenem etzadroxil
Sponsor	Trials
Iterum Therapeutics, International Limited	6
Iterum Therapeutics, US Limited	3

Sponsor Type

Sponsor Type for probenecid; sulopenem etzadroxil
Sponsor	Trials
Industry	9

Probenecid; Sulopenem Etzadroxil: Clinical, Market Status, and Forward Projections

Last updated: May 11, 2026

What is the current clinical-trial and regulatory status for probenecid; sulopenem etzadroxil?

Probenecid; sulopenem etzadroxil is a combination product that pairs probenecid with sulopenem etzadroxil (an oral prodrug form intended to deliver sulopenem exposure) to support antibacterial treatment while modulating pharmacokinetics via probenecid.

No complete, citable dataset was available in the provided information to produce a legally defensible, date-specific clinical-trials update (trial identifiers, phase, enrollment, endpoints, results, and timelines) or regulatory status (country-by-country approvals, complete response letters, or submitted dossiers) for probenecid; sulopenem etzadroxil.

Is there investable market traction evidence (approvals, launches, uptake) for this combination?

A market analysis requires hard anchors: approved label(s), launch geography and launch year, public sales data (or modeled commercial proxy like prescriptions/claims), and payer coverage. The supplied information contains none of these anchors for probenecid; sulopenem etzadroxil.

No complete, citable evidence was available to quantify:

• approved indications and label restrictions
• launch status by geography
• real-world utilization (prescriptions, days of therapy, treated episodes)
• price and reimbursement dynamics
• competitor position by MOA and setting

How should forward market projections be built for probenecid; sulopenem etzadroxil?

Projections must be grounded in at least one of the following: (1) current clinical readouts that predict probability of success and label size, (2) regulatory status that defines eligible markets and timelines, or (3) early launch metrics that calibrate demand. The supplied information provides none of these building blocks.

No complete and accurate projection can be produced without generating unsupported assumptions.

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Market model framework (what drives demand for an oral beta-lactam/prodrug combination like this)

The commercial shape for an oral antibacterial combination like probenecid; sulopenem etzadroxil is typically determined by:

1. Indication size and setting

   • outpatient vs inpatient
   • empiric vs targeted use
   • resistance profile fit (where the drug’s spectrum is positioned)

2. Clinical differentiation

   • efficacy vs standard of care in noninferiority or superiority designs
   • safety tolerability in real-world dosing
   • dosing convenience (oral regimen adherence)

3. Reimbursement and formulary access

   • payer preference and prior authorization requirements
   • step edits against generics and established brands

4. Competitive environment

   • oral beta-lactam and cephalosporin competitors
   • other oral carbapenem-like strategies (where applicable)
   • stewardship and guideline placement

This framework is directional only; it cannot be translated into credible numeric forecasts without citable inputs.

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Comparable structures: what to benchmark

When probenecid is used with a beta-lactam or related antibacterial strategy, commercial outcomes usually track to:

• oral adoption patterns in community-acquired infections
• antibiotic resistance positioning and stewardship alignment
• net price versus generics and guideline inclusions

To benchmark accurately, a dataset of comparable approvals (drug class, route, indication set, launch year, price, and uptake ramp) is required. The supplied information does not include such a dataset for probenecid; sulopenem etzadroxil.

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Key Takeaways

• A credible clinical trials update for probenecid; sulopenem etzadroxil cannot be produced from the information provided because it lacks trial identifiers, phase context, enrollment status, readouts, and regulatory milestones.
• A credible market analysis and numeric projection cannot be produced because it lacks approval status, indication scope, launch geography, uptake metrics, pricing, and payer coverage.

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FAQs

1. What clinical phase is probenecid; sulopenem etzadroxil in?
   The provided information does not contain citable phase-specific trial data.

2. What indications does probenecid; sulopenem etzadroxil target?
   The provided information does not include a citable label or development indication list.

3. Has probenecid; sulopenem etzadroxil been approved or launched anywhere?
   The provided information does not include any citable approval or launch evidence.

4. What market size can be expected at launch?
   No citable inputs (label scope, penetration drivers, pricing, uptake) were provided to support a numeric forecast.

5. What are the main commercial risks for this combination?
   The provided information includes no trial or regulatory outcomes to map the risk to evidence-based probabilities of success.

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References

[1] No sources were provided in the prompt for probenecid; sulopenem etzadroxil.