What's the most recent regulatory action in Urinary tract infectious disease?

Most recent: Monurol — FDA approved.

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Last reviewed 2026-06-10 · How we verify

Urinary tract infectious disease — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Urinary tract infectious disease (disease) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Urinary tract infectious disease, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Fetroja	CEFIDEROCOL	Shionogi	Cephalosporin Antibacterial		2019-01-01
Recarbrio	RELEBACTAM	Merck & Co.	Renal Dehydropeptidase Inhibitor [EPC]		2019-01-01
Zerbaxa	CEFTOLOZANE	Cubist Pharms	Cephalosporin Antibacterial		2014-01-01
Osmoprep	sodium phosphate, monobasic, monohydrate	Salix Pharms	Calculi Dissolution Agent [EPC]		2000-01-01
ALATROFLOXACIN	ALATROFLOXACIN	Pfizer	alatrofloxacin		1997-01-01
Monurol	FOSFOMYCIN	Zambon Spa	fosfomycin		1996-01-01
Azactam	AZTREONAM	Bristol-Myers Squibb	Monobactam Antibacterial [EPC]		1986-01-01
Augmentin 250	CLAVULANIC ACID	Dr Reddys Labs Inc	beta Lactamase Inhibitor		1984-01-01
Lithostat	ACETOHYDROXAMIC ACID	Mission Pharma	Urease Inhibitor [EPC]	Carbonic anhydrase 2	1983-01-01
AZLOCILLIN	AZLOCILLIN	Bayer Pharmaceuticals Corp	azlocillin		1982-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-04-09 — Monurol · FDA · approved · US

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

· 20 drugs in Urinary tract infectious disease
Bristol-Myers Squibb · 5 drugs in Urinary tract infectious disease
Pfizer · 5 drugs in Urinary tract infectious disease
Eli Lilly · 2 drugs in Urinary tract infectious disease
Bayer Pharmaceuticals Corp · 1 drug in Urinary tract infectious disease
Arbor Pharms Llc · 1 drug in Urinary tract infectious disease
Astellas Pharma · 1 drug in Urinary tract infectious disease
Daiichi Sankyo · 1 drug in Urinary tract infectious disease
Dr Reddys Labs Inc · 1 drug in Urinary tract infectious disease
Dr Reddys Labs Sa · 1 drug in Urinary tract infectious disease
Cubist Pharms · 1 drug in Urinary tract infectious disease
Assistance Publique - Hôpitaux de Paris · 1 drug in Urinary tract infectious disease

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Every new regulatory action, PDUFA date, or trial completion in Urinary tract infectious disease:

Cite this brief

Drug Landscape (2026). Urinary tract infectious disease — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/urinary-tract-infectious-disease. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing