Complicated Urinary Tract Infections

Pipeline Programs

Companies

Clinical Trials

Approved Products

Pipeline by Development Stage

Preclinical

Phase 1

Phase 1/2

Phase 2

Phase 2/3

Phase 3

On Market

Early DiscoveryClinical DevelopmentMarket

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Pre

P1/2

P2/3

Mkt

Allecra TherapeuticsFrance - Saint Louis

1 program

enmetazobactamPhase 31 trial

Active Trials

NCT05826990Unknown40Est. Mar 2026

SandozAustria - Kundl

1 program

LYS228Phase 2

NovartisBASEL, Switzerland

1 program

LYS228PHASE_21 trial

Active Trials

NCT03377426Withdrawn0Est. Oct 2019

Iterum TherapeuticsDUBLIN 1, Ireland

1 program

SulopenemPHASE_31 trial

Active Trials

NCT03357614Completed1,395Est. Dec 2019

Trial Timeline

Clinical trial activity over time

2021

2022

2023

2024

2025

2026

Iterum TherapeuticsSulopenem

Allecra Therapeuticsenmetazobactam

NovartisLYS228

Clinical Trials (3)

Total enrollment: 1,435 patients across 3 trials

NCT03357614 Iterum TherapeuticsSulopenem

Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Complicated UTI in Adults

Start: Sep 2018Est. completion: Dec 20191,395 patients

Phase 3Completed

NCT05826990 Allecra Therapeuticsenmetazobactam

A Study to Investigate PK, Safety, Tolerability of Cefepime-enmetazobactam in Pediatric Participants With cUTI

Start: Sep 2023Est. completion: Mar 202640 patients

Phase 2Unknown

NCT03377426 NovartisLYS228

LYS228 PK, Clinical Response, Safety and Tolerability in Patients With Complicated Urinary Tract Infection (cUTI)

Start: Oct 2018Est. completion: Oct 20190

Phase 2Withdrawn

Phase Legend

Preclinical— Lab & animal studies

Phase 1— Safety & dosing

Phase 2— Efficacy testing

Phase 3— Large-scale trials

On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals

4 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.