Drugs / plazomicin

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) ZEMDRI 2018-06-25 fda.gov

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

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04699656 Jan → Mar 2021 end stage renal failure Cipla USA Inc. Completed No outcome recorded
Phase 1 NCT03270553 Aug → Oct 2017 Achaogen, Inc. Completed No outcome recorded
Phase 1 NCT03177278 Jun → Jul 2017 Achaogen, Inc. Completed No outcome recorded
Phase 1 NCT01514929 Oct 2011 → Mar 2012 Achaogen, Inc. Completed No outcome recorded
Phase 1 NCT01462136 Sep 2011 → ? impaired renal function disease Achaogen, Inc. Completed No outcome recorded
Phase 21 trial
Phase 2 NCT01096849 Jul 2010 → Apr 2012 acute pyelonephritis Achaogen, Inc. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT02486627 Jan → Sep 2016 acute pyelonephritis Achaogen, Inc. Completed No outcome recorded
Phase 3 NCT01970371 Sep 2014 → Aug 2016 acute pyelonephritis, bacterial pneumonia Achaogen, Inc. Completed No outcome recorded
Also used as a comparator or background therapy in 2 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT01034774 Comparator Jan → Jun 2010 Achaogen, Inc. Completed No outcome recorded
Phase 1 NCT00822978 Comparator Jan → Oct 2009 Achaogen, Inc. Completed No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 14 sources stand behind the page.

FieldValueCited text
Known as Plazomicin “A Phase 1 Study To Assess the Pharmacokinetics of Intravenous Plazomicin in Adult Subjects with Varying Degrees of Renal Function.” PMID 30275092 Nov 2018
6

NCT04699656

NCT01096849

NCT03177278

NCT01970371

NCT03270553

NCT02486627

Known as ACHN-490 ClinicalTrials.gov intervention name — accepted as the source's own label NCT00822978
3

NCT01514929

NCT01034774

NCT01462136

Known as ACHN-490 Injection ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days.” NCT01034774
Known as ACHN-490 SULFATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1650559
Known as Plazomicin hemipentasulfate ChEMBL registry synonym — accepted as the source's own label CHEMBL1650559
Known as PLAZOMICIN SULFATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1650559
Known as Plazomicina ChEMBL registry synonym — accepted as the source's own label CHEMBL1650559
Known as Plazomicine ChEMBL registry synonym — accepted as the source's own label CHEMBL1650559
Known as Zemdri ChEMBL registry synonym — accepted as the source's own label CHEMBL1650559
Action Inhibit “Plazomicin inhibited OCT2, MATE1, and MATE2-K transporters” PMID 30605260 Jan 2019
Modality Small molecule “Plazomicin is an aminoglycoside” PMID 30786187 Feb 2019
Route Intravenous “Administered Intravenously in Healthy Volunteers” NCT00822978