Drugs / Methenamine Hippurate

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) UREX — 1967-07-05 fda.gov ↗

Trials 8

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT06710899 Jan → Aug 2027 expected urinary tract infection University Hospitals of North Midlands NHS Trust Not yet recruiting No outcome recorded
Phase 22 trials · 1 met primary
Phase 2 NCT07202949 Feb 2026 → Oct 2027 expected urinary tract infection University College, London Recruiting No outcome recorded
Phase 2 NCT03818321 Jun 2019 → Jul 2021 pelvic organ prolapse, urinary tract infection, urinary tract obstruction TriHealth Inc. Completed Met primary
Phase 44 trials · 1 met primary
Phase 4 NCT06953271 May 2025 → May 2026 overdue overactive bladder, urinary tract infection Women and Infants Hospital of Rhode Island Not yet recruiting No outcome recorded
Phase 4 NCT04709601 Jan 2021 → Dec 2024 urinary tract infection University of Texas Southwestern Medical Center Terminated No outcome recorded
Phase 4 NCT04077580 Nov 2019 → Jun 2023 urinary tract infection University of Oslo Completed Met primary
Phase 4 NCT03996057 Jun 2018 → Feb 2022 female reproductive system disorder, urinary tract infection Washington University School of Medicine Withdrawn No outcome recorded
Phase not applicable1 trial
— NCT02358993 Dec 2014 → Sep 2020 prosthesis-related infectious disease, urinary tract infection University of Pennsylvania Completed No outcome recorded
Comparator or background therapy1 trial
Phase 4 NCT03077711 Comparator Jun 2016 → Jun 2019 urinary tract infection Endeavor Health Completed No outcome recorded

News releases announcing trial results or a regulatory action · 1

DateIssuerRelease
2025-03-12 Zydus Lifesciences Limited Regulatory Zydus receives final approval from USFDA for Methenamine Hippurate Tablets USP, 1 gram zyduslife.com ↗

All press releases naming this drug 1 release

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited text
Known as methenamine hippurate ClinicalTrials.gov intervention name — accepted as the source's own label NCT02358993 ↗
7

NCT03818321 ↗

NCT03077711 ↗

NCT06953271 ↗

NCT03996057 ↗

NCT07202949 ↗

NCT04077580 ↗

NCT06710899 ↗

Known as Hiprex “Does Vitamin C Improve the Efficacy of Methenamine Hippurate (Hiprex®) in Prophylaxis of Recurrent Urinary Tract Infections? A Proof of Concept Study” NCT06710899 ↗
1

NCT04709601 ↗

Route Oral “1 tablet by mouth every 12 hours for 24 hours” NCT02358993 ↗