Drugs / sulopenem etzadroxil
sulopenem etzadroxil
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed urinary tract infection 1 milestone | |||||
| Filed | US (FDA) | — | urinary tract infection | 2020-11-30 | “submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid” iterumtx.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | ORLYNVAH | — | 2024-10-25 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07092813 | Apr → Oct 2026 expected | — | Iterum Therapeutics, International Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT04700787 | Apr 2021 → Mar 2022 | acute pyelonephritis, infectious peritonitis | Iterum Therapeutics, International Limited | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00759564 | Nov 2008 → Mar 2010 | pneumonia | Pfizer | Completed | No outcome recorded |
| Phase 21 trial · 1 missed | ||||||
| Phase 2 | NCT00797108 | Jan → Jun 2009 | bacterial pneumonia | Pfizer | Completed | Missed primary |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05584657 | Oct 2022 → Nov 2023 | cystitis, urinary tract infection | Iterum Therapeutics, International Limited | Completed | Met primary |
| Phase 3 | NCT03358576 | Sep 2018 → Oct 2019 | intestinal infectious disease | Iterum Therapeutics, International Limited | Completed | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT04682834 | — | acute pyelonephritis | Iterum Therapeutics, International Limited | No longer available | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Publication of REASSURE Trial in NEJM Evidence iterumtx.com ↗
“We are very pleased that NEJM Evidence have published the results from the REASSURE trial,” said Corey Fishman, Iterum’s Chief Executive Officer. |
| 2024-10-25 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. |
| 2024-06-21 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Announces FDA Advisory Committee Meeting to discuss NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
The proposed date for the Advisory Committee meeting is September 9, 2024. |
| 2024-05-31 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
As a result, the FDA has assigned a PDUFA action date of October 25, 2024. |
| 2024-04-29 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem iterumtx.com ↗
today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. |
| 2024-01-30 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections iterumtx.com ↗
With the positive data from this trial, we plan to resubmit our New Drug Application (NDA) for oral sulopenem for the treatment of uUTI in the second quarter of 2024. |
| 2022-07-11 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA iterumtx.com ↗ |
| 2021-07-26 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem iterumtx.com ↗
today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021. |
| 2021-07-01 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Provides Regulatory Update iterumtx.com ↗
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company received a letter from the U.S. Food and Drug Administration (“FDA”) stating that, as part of their ongoing review of the Company’s New Drug Application (“NDA”) for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time. |
| 2021-01-25 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem iterumtx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. |
| 2020-11-30 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem iterumtx.com ↗
today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) |
| 2018-10-05 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Presents Data Highlighting Antibiotic Sulopenem at IDWeek 2018 iterumtx.com ↗
Probenecid was found to increase the area under the curve (AUC) of sulopenem by 28 percent |
All press releases naming this drug 12 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sulopenem etzadroxil | “The following day, patients will receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.” NCT04700787 ↗ |
| Known as | PF-03709270 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00759564 ↗ |
| Known as | Sulopenem etzadroxil component of orlynvah | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594246 ↗ |
| Modality | Small molecule | “Sulopenem is a broad-spectrum penem β-lactam antibiotic” NCT07092813 ↗ |
| Route | Oral | “single oral dose of PF-03709270 (1000 mg)” NCT00759564 ↗ |