Drugs / Zoliflodacin
Zoliflodacin
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | NUZOLVENCE | — | 2025-12-12 | fda.gov ↗ |
Trials 8 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT03718806 | Oct → Nov 2018 | gonorrhea | Drugs for Neglected Diseases | Completed | No outcome recorded |
| Phase 1 | NCT03613649 | Sep 2018 → Jan 2019 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT03404167 | Feb → Mar 2018 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT02298920 | Jan → Feb 2015 | — | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT01929629 | Sep 2013 → Mar 2014 | gonorrhea | AstraZeneca | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02257918 | Nov 2014 → Dec 2015 | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03959527 | Nov 2019 → Aug 2023 | gonorrhea | Global Antibiotics Research and Development Partnership | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07640477 | Oct 2026 → Nov 2027 expected | testicular anomalies with or without congenital heart disease | Global Antibiotics Research and Development Partnership | Not yet recruiting | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zoliflodacin | “Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent” NCT03404167 ↗4“Single-Dose Zoliflodacin (ETX0914) for Treatment of Urogenital Gonorrhea.” PMID 30403954 ↗ Nov 2018 |
| Known as | AZD0914 | “Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent” NCT03404167 ↗ |
| Known as | ETX0914 | “Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent” NCT03404167 ↗1“The drug name is also known as ETX0914.” NCT02257918 ↗ |
| Known as | Zoliflodacina | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544978 ↗ |
| Known as | Zoliflodacine | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544978 ↗ |
| Action | Inhibit | “inhibits DNA biosynthesis” PMID 30373802 ↗ Dec 2018 |
| Modality | Small molecule | “The first in class zoliflodacin (spiropyrimidinetrione, DNA Gyrase B inhibitor) is a promising novel antimicrobial” PMID 38130409 ↗ Dec 2023 |
| Route | Oral | “orally administered AZD0914” NCT01929629 ↗ |