---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-049928"
form_type: "8-K"
ticker: "ITRMF"
cik: "0001659323"
company_name: "Iterum Therapeutics plc"
filed_at: "2024-04-29T23:59:59+00:00"
generated_at: "2026-06-03T05:37:33.202010+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Iterum resubmits NDA for oral sulopenem to FDA for uUTIs; potential approval early Q4 2024

## Summary
- Resubmitted NDA on April 29, 2024, for oral sulopenem (sulopenem etzadroxil/probenecid) for uncomplicated UTIs in adult women.
- REASSURE trial showed oral sulopenem non-inferior and statistically superior to Augmentin in uUTI patients with susceptible pathogens.
- SURE 1 trial demonstrated statistical superiority of oral sulopenem vs ciprofloxacin in patients with quinolone non-susceptible pathogens.
- FDA review expected to complete six months from receipt; potential approval early Q4 2024, addressing July 2021 CRL deficiencies.
- If approved, would be first oral penem in the U.S. and second new oral uUTI treatment in over 25 years.

## SEC filing metadata
- accession: 0000950170-24-049928
- form_type: 8-K
- ticker: ITRMF
- cik: 0001659323
- company_name: Iterum Therapeutics plc
- filed_at: 2024-04-29T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1659323/000095017024049928/0000950170-24-049928-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1659323/000095017024049928/itrm-20240429.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-049928
- JSON: https://secwatch.observer/filing/0000950170-24-049928.json
- Plain text: https://secwatch.observer/filing/0000950170-24-049928.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.