Drugs / taniborbactam
taniborbactam
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | pyeloureteritis cystica | 2024-01-09 | “A New Drug Application for cefepime-taniborbactam was accepted for review by the US FDA for cUTI” menarini.com ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04951505 | Jun → Sep 2021 | — | Venatorx Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03870490 | Mar → Apr 2019 | — | Venatorx Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03690362 | Apr → Nov 2018 | — | Venatorx Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03332732 | Oct → Dec 2017 | bacterial infectious disease | Venatorx Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02955459 | Nov 2016 → Jun 2017 | bacterial infectious disease | Venatorx Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 32 trials · 1 met primary | ||||||
| Phase 3 | NCT06168734 | Jun 2025 → Jun 2027 | bacterial pneumonia | Venatorx Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT03840148 | Aug 2019 → Dec 2021 | acute pyelonephritis | Venatorx Pharmaceuticals, Inc. | Completed | Met primary |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2024-01-09 | Menarini Group | Venatorx Pharmaceuticals and Menarini Group Enter Commercial Agreement for Cefepime-Taniborbactam in 96 Countries menarini.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | taniborbactam | “Taniborbactam (formerly VNRX-5133), an investigational β-lactamase inhibitor active against both serine- and metallo-β-lactamases, is being developed in combination with...” PMID 34370573 ↗ Aug 20214“Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment.” PMID 35920662 ↗ Aug 2022 |
| Known as | Taniborbactam dihydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594290 ↗ |
| Known as | TANIBORBACTAM HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594290 ↗ |
| Known as | VNRX-5133 | “Taniborbactam (formerly VNRX-5133), an investigational β-lactamase inhibitor active against both serine- and metallo-β-lactamases, is being developed in combination with...” PMID 34370573 ↗ Aug 20214“Safety and Pharmacokinetics of Taniborbactam (VNRX-5133) with Cefepime in Subjects with Various Degrees of Renal Impairment.” PMID 35920662 ↗ Aug 2022 “Cefepime/VNRX-5133 (taniborbactam)” NCT03840148 ↗ |
| Known as | VNRX-5133 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594290 ↗ |
| Known as | VNRX-5133 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4594290 ↗ |
| Action | Inhibit | “an investigational β-lactamase inhibitor” PMID 34370573 ↗ Aug 2021 |
| Modality | Other / unclassified | “Cefepime-taniborbactam is an investigational β-lactam and β-lactamase inhibitor combination” PMID 38354140 ↗ Feb 2024 |
| Route | Intravenous | “all taniborbactam doses were administered as a 2-h intravenous infusion” PMID 34370573 ↗ Aug 2021 |