Drugs / sulopenem etzadroxil
sulopenem etzadroxil
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ORLYNVAH | — | 2024-10-25 | fda.gov ↗ |
Trials 7 · a red edge is where a trial was stopped
| 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| Apr 2021 → Mar 2022 | acute pyelonephritis, infectious peritonitis | Iterum Therapeutics, International Limited | Withdrawn | No outcome recorded |
| Phase 1 | NCT00759564 | Nov 2008 → Mar 2010 | pneumonia | Pfizer | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT00797108 | Jan → Jun 2009 | bacterial pneumonia | Pfizer | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05584657 | Oct 2022 → Nov 2023 | cystitis, urinary tract infection | Iterum Therapeutics, International Limited | Completed | No outcome recorded |
| Phase 3 | NCT03358576 | Sep 2018 → Oct 2019 | intestinal infectious disease | Iterum Therapeutics, International Limited | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04682834 | — | acute pyelonephritis | Iterum Therapeutics, International Limited | No longer available | No outcome recorded |
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 NCT00797108 ↗ |
| 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 ↗ |