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Sulopenem FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 10, 2020.

FDA Approved: No
Generic name: sulopenem
Company: Iterum Therapeutics plc
Treatment for: Bacterial Infection

Sulopenem is an orally bioavailable, broad-spectrum penem β-lactam antibiotic in development for the treatment of infections caused by multi-drug resistant bacteria.

Development timeline for sulopenem

DateArticle
Apr 29, 2024Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
Jan 30, 2024Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
Oct 20, 2022Iterum Announces First Patient Dosed in REASSURE, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections
Jul 27, 2021Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem
Jan 25, 2021Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem
Nov 30, 2020Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem
Jun 29, 2020Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections
Dec 26, 2019Iterum Therapeutics Announces Completion of Enrollment in Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infection
Dec 10, 2019Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal Infections
Sep 19, 2018Iterum Initiates SURE 2 and SURE 3 Phase 3 Clinical Trials of IV and Oral Sulopenem in Complicated Urinary Tract and Complicated Intra-abdominal Infections

Further information

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