Drugs / Zidebactam
Zidebactam
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZAYNICH | — | 2026-05-29 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 17 trials | ||||||
| Phase 1 | NCT06806995 | Jan → Feb 2025 | pseudohypoparathyroidism type 1A | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT05645757 | Apr → Nov 2023 | bacterial infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT07247942 | Dec 2017 → Jan 2018 | — | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT03630094 | Mar → Jun 2017 | pseudohypoparathyroidism type 1A | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02942810 | Oct 2016 → Apr 2017 | impaired renal function disease | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02674347 | Feb → Apr 2016 | — | Wockhardt | Completed | No outcome recorded |
| Phase 1 | NCT02532140 | Aug → Nov 2015 | — | Wockhardt | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04979806 | Aug 2022 → Nov 2024 | acute pyelonephritis | Wockhardt | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02707107 Comparator | Mar → Apr 2016 | gram-negative bacterial infections | Wockhardt | Completed | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zidebactam | “A Single-center, Open-label, Study Evaluating Safety and Pharmacokinetics of Single Doses of Zidebactam-Cefepime and Metronidazole Alone or in Combination Utilizing a 3-Period,...” NCT06806995 ↗7“WCK 5222 is a novel β-lactam-β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID).” PMID 30397067 ↗ Dec 2018 “3 g of zidebactam (1 g q8h) and 6 g of cefepime (2 g q8h) or 6” NCT02707107 ↗ “WCK 5222 (Cefepime and Zidebactam)” NCT03630094 ↗ |
| Known as | WCK 5107 | “Study of the Metabolism and Excretion of Zidebactam (WCK 5107) Following a Single Intravenous Infusion.” NCT07247942 ↗ |
| Known as | ZID | “WCK 5222 is a novel β-lactam-β-lactam-enhancer combination of cefepime (FEP) and zidebactam (ZID).” PMID 30397067 ↗ Dec 2018 |
| Action | Inhibit | “A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class” NCT05645757 ↗ |
| Modality | Small molecule | “A betaß-lactamase inhibitor and betaß-lactam enhancer from the diazabicyclooctane (DBO) class” NCT05645757 ↗ |
| Route | Intravenous | “single intravenous doses of WCK 5107 alone and in combination with cefepime” NCT02532140 ↗ |