Drugs / Durlobactam
Durlobactam
also known as
ETX2514 · DUR · DURLOBACTAM SODIUM · Durlobactam sodium component of xacduro · ETX-2514 SODIUM · EXT2514
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | XACDURO (COPACKAGED) | — | 2023-05-23 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT06801223 | Dec 2026 → May 2028 expected | Acinetobacter infectious disease | Innoviva Specialty Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT04018950 | Jun → Jul 2019 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03985410 | May → Jul 2019 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03310463 | Oct 2017 → May 2018 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03303924 | Aug → Oct 2017 | — | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02971423 | Oct 2016 → Jun 2017 | Acinetobacter infectious disease | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03445195 | Jan → May 2018 | acute pyelonephritis | Entasis Therapeutics | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT03894046 | Sep 2019 → Jul 2021 | Acinetobacter infectious disease, bacterial pneumonia | Entasis Therapeutics | Completed | Met primary |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-05-17 | Zai Lab (Shanghai) Co., Ltd. | Regulatory Zai Lab Announces CTA Acceptance for a Phase 3 Clinical Trial of ETX2514SUL for the Treatment of Carbapenem-Resistant Acinetobacter Infections zailaboratory.com ↗
Zai Lab Announces CTA Acceptance for a Phase 3 Clinical Trial of ETX2514SUL for the Treatment of Carbapenem-Resistant Acinetobacter Infections |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-11-21 | Zai Lab (Shanghai) Co., Ltd. | Zai Lab and Pfizer Announce Strategic Collaboration on the Novel Antibacterial Drug XACDURO® (Sulbactam-Durlobactam) zailaboratory.com ↗ |
| 2020-05-18 | Zai Lab (Shanghai) Co., Ltd. | Zai Lab Announces First Chinese Patient Dosed in the Global Phase 3 ATTACK Trial of Sulbactam-Durlobactam for Patients with Carbapenem-Resistant Acinetobacter Infections zailaboratory.com ↗ |
| 2019-05-17 | Zai Lab (Shanghai) Co., Ltd. | Zai Lab Announces CTA Acceptance for a Phase 3 Clinical Trial of ETX2514SUL for the Treatment of Carbapenem-Resistant Acinetobacter Infections zailaboratory.com ↗ |
| 2018-04-25 | Zai Lab (Shanghai) Co., Ltd. | Entasis Therapeutics and Zai Lab Announce Exclusive License Agreement in Asia-Pacific and Global Strategic Development Collaboration for ETX2514 zailaboratory.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Durlobactam | “Durlobactam (DUR; also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases.” PMID 32284380 ↗ Jun 20203“Durlobactam (DUR; ETX2514) is a novel β-lactamase inhibitor with broad-spectrum activity against Ambler class A, C, and D β-lactamases.” PMID 31843995 ↗ Feb 2020 |
| Known as | DUR | “Durlobactam (DUR; ETX2514) is a novel β-lactamase inhibitor with broad-spectrum activity against Ambler class A, C, and D β-lactamases.” PMID 31843995 ↗ Feb 2020 |
| Known as | DURLOBACTAM SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298137 ↗ |
| Known as | Durlobactam sodium component of xacduro | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298137 ↗ |
| Known as | ETX-2514 SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298137 ↗ |
| Known as | ETX2514 | “Durlobactam (DUR; also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases.” PMID 32284380 ↗ Jun 20205“Durlobactam (DUR; ETX2514) is a novel β-lactamase inhibitor with broad-spectrum activity against Ambler class A, C, and D β-lactamases.” PMID 31843995 ↗ Feb 2020 |
| Known as | EXT2514 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4298137 ↗ |
| Action | Inhibit | “Durlobactam (DUR; also known as ETX2514) is a novel β-lactamase inhibitor with broad activity against Ambler class A, C, and D β-lactamases.” PMID 32284380 ↗ Jun 2020 |
| Modality | Small molecule | — CHEMBL4298137 ↗ |
| Route | Intravenous | “SUL-DUR at 1 g (of each component) administered q6h with a 3-h intravenous (i.v.) infusion is under development for the treatment of serious infections due to A. baumannii” PMID 32284380 ↗ Jun 2020 |