Drugs / Sulopenem
Sulopenem
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Rejected (CRL) | US (FDA) | — | urinary tract infection | 2021-07-23 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem” iterumtx.com ↗ “complete response letter received from the U.S. Food and Drug Administration in July 2021” iterumtx.com ↗ |
| Filed | US (FDA) | — | urinary tract infection | — | “In January 2021, the FDA accepted for review our NDA for uUTI in patients with a quinolone non-susceptible organism.” iterumtx.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| 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| Apr 2021 → Mar 2022 | acute pyelonephritis, infectious peritonitis | Iterum Therapeutics, International Limited | Withdrawn | No outcome recorded Stop: Enrollment |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 33 trials · 2 missed | ||||||
| Phase 3 | NCT03357614 | Sep 2018 → Dec 2019 | urinary tract infection | Iterum Therapeutics, International Limited | Completed | Missed primary |
| Phase 3 | NCT03358576 | Sep 2018 → Oct 2019 | intestinal infectious disease | Iterum Therapeutics, International Limited | Completed | Missed primary |
| Phase 3 | NCT03354598 | Aug 2018 → Jan 2020 | urinary tract infection | Iterum Therapeutics, International Limited | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| 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. |
| 2023-04-20 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Presents Scientific Posters at ECCMID 2023 Highlighting Application of Desirability of Outcomes Ranking (DOOR) to two Registration Trials iterumtx.com ↗
Applying the ARLGs approach retrospectively to our two Phase 3 studies of sulopenem, one each in cUTI and uUTI, respectively, demonstrated that oral sulopenem was comparably more effective than ciprofloxacin in patients with uUTI |
| 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) |
| 2020-06-29 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Topline Results from its Phase 3 Clinical Trial of Oral Sulopenem for the Treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
In the population of patients with baseline pathogens resistant to quinolones, sulopenem achieved the related primary endpoint by demonstrating superiority to ciprofloxacin, providing substantial evidence of a treatment effect in patients with uUTI. |
| 2020-06-01 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Topline Results for a Phase 3 Clinical Trial of Oral and IV Sulopenem in Complicated Urinary Tract Infection iterumtx.com ↗
Responder rates at the test of cure visit for sulopenem were 67.8% (301 of 444 patients) and for ertapenem were 73.9% (325 of 440 patients) with a difference of -6.1% (95% confidence interval (CI): -12.0%, - 0.1%). |
| 2019-12-10 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Topline Results from Phase 3 Clinical Trial of Oral and IV Sulopenem for the Treatment of Complicated Intra-abdominal Infections iterumtx.com ↗
today announced topline results from its Su lopenem for R esistant E nterobacteriaceae (SURE) 3 clinical trial in complicated intra-abdominal infections (cIAI). |
| 2019-04-11 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Presents Data on Risks for Treatment Failure Associated with Uncomplicated Urinary Tract Infection and Activity of its Novel Antibiotic Sulopenem at ECCMID 2019 iterumtx.com ↗
Sulopenem demonstrated in vitro activity against isolates of N. gonorrhoeae non-susceptible to ceftriaxone and cefixime, as well as those resistant to azithromycin or ciprofloxacin. |
| 2019-03-19 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives QIDP for Oral and IV Sulopenem in Four Additional Indications as well as Fast Track Designation iterumtx.com ↗
Fast Track designation for all seven of these indications in both the oral and intravenous formulations has also been granted. |
| 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 |
| 2018-06-06 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics to Present Data on Prevalence of Resistant Infections and In Vitro Activity of its Novel Antibiotic Sulopenem iterumtx.com ↗
Sulopenem demonstrated potent in vitro activity against organisms commonly implicated in urinary tract and intra-abdominal infections, including those caused by ESBL-producing or quinolone non-susceptible pathogens. |
| 2018-04-20 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Presents Data on Prevalence of Resistant Infections and Activity of its Novel Antibiotic Sulopenem iterumtx.com ↗
Oral sulopenem provides potent antimicrobial activity in the urine |
| 2017-10-04 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics reveals new US maps highlighting antibiotic resistance ‘hotspots’ iterumtx.com ↗
The Phase 1 pharmacokinetics study documents that oral prodrug absorption is sufficient to exceed the mean inhibitory concentrations (MICs) of the target resistant pathogens. |
| 2017-01-05 | Pfizer | Regulatory Iterum Announces Sulopenem in Development for Treatment of Gram-Negative, Multi-drug Resistant Infections pfizer.com ↗
Oral and IV Formulation Broad-spectrum Antibiotic for Use in Hospital and Community Settings Granted Qualified Infectious Disease Product (QIDP) Designation by U.S. FDA |
| 2017-01-05 | Iterum Therapeutics, International Limited | Regulatory Iterum Announces Sulopenem in Development for Treatment of Gram-Negative, Multi-drug Resistant Infections iterumtx.com ↗
Oral and IV Formulation Broad-spectrum Antibiotic for Use in Hospital and Community Settings Granted Qualified Infectious Disease Product (QIDP) Designation by U.S. FDA |
All press releases naming this drug 40 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Sulopenem | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03357614 ↗ |
| Known as | CP-70,429 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00759564 ↗ |
| Known as | CP-70,429 - sulopenem | “CP-70,429 - sulopenem” NCT00759564 ↗ |
| Modality | Small molecule | — CHEMBL1908305 ↗ |
| Route | Intravenous | “800 mg given as a 1.5 hour intravenous infusion” NCT00759564 ↗ |