Drugs / Eravacycline

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Xerava 2018-09-20 europa.eu
Approved US (FDA) XERAVA 2018-08-27 fda.gov

Trials 12 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT03696550 Dec 2018 → Mar 2021 bacterial infectious disease Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT02135276 Dec 2013 → Mar 2014 end stage renal failure Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT02135302 Oct 2013 → Feb 2014 Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT01941446 Mar → Jun 2013 Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 1 NCT01989949 Nov 2012 → Jan 2013 Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 23 trials
Phase 2 NCT06794541 May 2025 → Feb 2029 expected Tetraphase Pharmaceuticals, Inc Recruiting No outcome recorded
Phase 2 NCT05537896 Feb 2024 → Feb 2028 expected hematopoietic and lymphoid cell neoplasm, neutropenia West Virginia University Recruiting No outcome recorded
Phase 2 NCT01265784 Jan 2011 → May 2012 Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 34 trials
Phase 3 NCT03032510 Jan → Dec 2017 urinary tract infection Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 3 NCT02784704 Oct 2016 → May 2017 appendicitis Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 3 NCT01978938 Oct 2014 → Jun 2015 urinary tract infection Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Phase 3 NCT01844856 Aug 2013 → Aug 2014 Tetraphase Pharmaceuticals, Inc Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 4 NCT07004049 Comparator Apr 2025 → Dec 2028 expected bacterial pneumonia, infectious disease with sepsis National University of Singapore Recruiting No outcome recorded
Phase 4 NCT06440304 Comparator Jan 2025 → Dec 2026 expected bacterial infectious disease with sepsis Clinical Hospital Centre Zagreb Recruiting No outcome recorded

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 16 sources stand behind the page.

FieldValueCited text
Known as Eravacycline “A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization” NCT01941446
12

“TP-434 (Eravacycline) reconstituted and administered via an IV infusion” NCT01989949

NCT06440304

NCT02135302

NCT02135276

NCT01978938

NCT03032510

NCT05537896

NCT06794541

NCT03696550

NCT07004049

NCT01844856

NCT02784704

Known as Eravaciclina ChEMBL registry synonym — accepted as the source's own label CHEMBL1951095
Known as ERAVACYCLINE DIHYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1951095
Known as TP-434 “A Thorough QT/QTc Study to Evaluate the Effects of an Intravenous Infusion of Eravacycline (TP-434) on Cardiac Repolarization” NCT01941446
3

“Eravacycline (TP-434) intravenous formulation” NCT03696550

NCT01989949

NCT01265784

Known as TP-434-046 ChEMBL registry synonym — accepted as the source's own label CHEMBL1951095
Known as Trade name: Xerava Trade name: Xerava™” NCT03696550
Known as Xerava ChEMBL registry synonym — accepted as the source's own label CHEMBL1951095
Modality Small molecule “Eravacycline is a novel, fully synthetic fluorocycline antibiotic of the tetracycline class” PMID 27851857 Mar 2017
Route Intravenous “TP-434 was administered intravenously (IV)” NCT01265784