Iterum Therapeutics (ITRM) FDA Approvals

Iterum Therapeutics' Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Iterum Therapeutics (ITRM). Over the past two years, Iterum Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as sulopenem. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Sulopenem etzadroxil/probenecid FDA Regulatory Timeline and Events

Sulopenem etzadroxil/probenecid is a drug developed by Iterum Therapeutics for the following indication: Uncomplicated urinary tract infections (uUTIs). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Published Results - June 25,2025

Phase 3

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: June 25, 2025
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics plc today reported that NEJM Evidence published results from its REASSURE (REnewed ASsessment of Sulopenem in uUTI caused by Resistant Enterobacterales) Phase 3 clinical trial comparing oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) to oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics announced that NEJM Evidence has published the results of the REASSURE Phase 3 clinical trial. This trial evaluated oral sulopenem (sulopenem etzadroxil combined with probenecid in a bilayer tablet) versus oral Augmentin® (amoxicillin/clavulanate) in adult women with uncomplicated urinary tract infections (uUTIs). The study aimed to show that sulopenem was not inferior to Augmentin® by using a 10% non-inferiority margin. Patients were given the assigned treatment twice daily for five days, and the main goal was to assess the overall response, which combined clinical cure and the eradication of the bacteria.

The results indicated that sulopenem achieved an overall success rate of 61.7% compared to 55.0% for Augmentin®. These findings highlight sulopenem’s potential as a new treatment option for uUTIs, especially given the rising issue of antibiotic resistance.

Poster Presentation - October 10,2024

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: October 10, 2024
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics announced that three posters will be presented at the Infectious Disease Society of America's IDWeek 2024 conference taking place in Los Angeles, CA from October 16-19, 2024.

Iterum Therapeutics announced that three research posters will be presented at the Infectious Disease Society of America’s IDWeek 2024 conference in Los Angeles, CA from October 16-19, 2024. The posters, all led by Dr. Steven I. Aronin, highlight important studies in the field of infections and antibiotic treatment. One poster discusses the results from the REASSURE Trial on oral sulopenem/probenecid for uncomplicated urinary tract infections (uUTI), while another presents a prospective analysis indicating that asymptomatic bacteriuria does not predict clinical failure in uUTI cases in women. A third poster showcases data from a study where sulopenem proved effective in a rabbit model of inhalational anthrax. After the conference concludes, all poster materials will be available on the company’s website under the "Publications: Posters & Presentations" page in the "Our Science" tab.

PDUFA Date - September 10,2024

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: September 10, 2024
• Target Action Date: October 25, 2024
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics plc announced that FDA Decision Expected by PDUFA Goal Date of October 25, 2024

Iterum Therapeutics has announced that the FDA is expected to make a decision on its new drug application for oral sulopenem by the PDUFA goal date of October 25, 2024. The application is for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. If approved, oral sulopenem could become the first oral penem available in the United States, offering a new treatment option for patients facing bacteria that are resistant to common antibiotics.

The decision is a critical step for Iterum as it works closely with the FDA during this review period to bring an innovative treatment to market. The company aims to provide physicians with an effective tool to combat uUTIs while also addressing concerns related to antibiotic resistance.

Provided Update - September 10,2024

FDA Meeting

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: September 10, 2024
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics announced that a meeting of the U.S. Food and Drug Administration's (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) took place on September 9, 2024 at which Iterum's new drug application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTI) in adult women was discussed.

Iterum Therapeutics announced that on September 9, 2024, the FDA’s Antimicrobial Drugs Advisory Committee discussed its new drug application (NDA) for sulopenem etzadroxil/probenecid, also known as oral sulopenem. The application focuses on treating uncomplicated urinary tract infections (uUTIs) in adult women over 18 years old. During the meeting, the committee reviewed the overall benefits and risks of using oral sulopenem based on scientific evidence, including data from Phase 3 clinical trials. They also examined important considerations to ensure that physicians use the drug appropriately to help limit antimicrobial resistance. Iterum’s CEO, Corey Fishman, expressed optimism about the discussion and emphasized the team’s commitment to working closely with the FDA as the review process proceeds, with an anticipated decision by the PDUFA goal date of October 25, 2024.

Provided Update - June 21,2024

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: June 21, 2024
• Target Action Date: September 9, 2024
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics plc announced that The proposed date for the Advisory Committee meeting is September 9, 2024.

Iterum Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) has selected its New Drug Application for oral sulopenem to be reviewed by an Advisory Committee. The committee will focus on discussing antimicrobial stewardship challenges associated with the use of what could become the first oral penem in the U.S. and determining the optimal patient groups for treating uncomplicated urinary tract infections in adult women. This upcoming meeting is important as it will outline the potential benefits and risks of this novel treatment, guiding both the approval process and clinical use. The proposed date for the Advisory Committee meeting is September 9, 2024, marking a significant milestone in the progress of Iterum’s efforts to address infections caused by multi-drug resistant pathogens and to bring new options to patients in both community and hospital settings.

Regulatory Update - June 21,2024

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: June 21, 2024
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum announced that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women will be taken to Advisory Committee, and in its communication, highlighted that the purpose of the Advisory Committee was to discuss a) antimicrobial stewardship issues raised by potential approval and subsequent use of what would be the first oral penem in the U.S.; and b) the most appropriate target patient population(s) for treatment of uUTI with sulopenem etzadroxil/probenecid.

Iterum Therapeutics announced that the FDA has decided to bring its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for uncomplicated urinary tract infections (uUTIs) in adult women before an Advisory Committee. The meeting is planned for September 9, 2024, and will focus on key issues regarding the drug’s potential approval. Specifically, the committee will review antimicrobial stewardship concerns associated with introducing the first oral penem in the United States. They will also discuss which patient groups would benefit most from treatment with oral sulopenem for uUTIs. This Advisory Committee review is part of a thorough process to ensure that the use of this new antibiotic is both safe and effective, while also considering its long-term impact on antibiotic resistance and overall patient care.

Regulatory Update - May 31,2024

NDA

• Drug: sulopenem etzadroxil/probenecid
• Announced Date: May 31, 2024
• Indication: Uncomplicated urinary tract infections (uUTIs)

Iterum Therapeutics plc announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmission of the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women.

Iterum Therapeutics has announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the resubmitted New Drug Application (NDA) for its oral sulopenem formulation, which combines sulopenem etzadroxil with probenecid. This application is specifically for treating uncomplicated urinary tract infections (uUTIs) in adult women. Under the Prescription Drug User Fee Act, the resubmission has been classified as a Class II complete response, giving the FDA a six-month review period, with a target action date of October 25, 2024.

This milestone shows progress in the company’s efforts to provide a new treatment option for uUTIs. The submission includes updated evidence from its clinical REASSURE trial, further supporting the potential of oral sulopenem as an effective treatment for these infections.