Drugs / Durlobactam

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) XACDURO (COPACKAGED) 2023-05-23 fda.gov

Trials 8 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 16 trials
Phase 1 NCT06801223 Oct 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
Phase 3 NCT03894046 Sep 2019 → Jul 2021 Acinetobacter infectious disease, bacterial pneumonia Entasis Therapeutics Completed No outcome recorded

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 9 sources stand behind the page.

FieldValueCited 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 2020
3

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

NCT06801223

NCT03894046

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 2020
5

“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

NCT04018950

NCT03303924

NCT03310463

NCT03985410

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