Drugs / plazomicin
plazomicin
also known as
ACHN-490 · ACHN-490 Injection · ACHN-490 SULFATE · Plazomicin hemipentasulfate · PLAZOMICIN SULFATE · Plazomicina · Plazomicine · Zemdri
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZEMDRI | — | 2018-06-25 | fda.gov ↗ |
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials · 2 met primary | ||||||
| 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 | Met primary |
| Phase 1 | NCT03177278 | Jun → Jul 2017 | — | Achaogen, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01514929 | Oct 2011 → Mar 2012 | — | Achaogen, Inc. | Completed | Met primary |
| 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 · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT02486627 | Jan → Sep 2016 | acute pyelonephritis | Achaogen, Inc. | Completed | Met primary |
| Phase 3 | NCT01970371 | Sep 2014 → Aug 2016 | acute pyelonephritis, bacterial pneumonia | Achaogen, Inc. | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| 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.
| Field | Value | Cited 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 |
| Known as | ACHN-490 | ClinicalTrials.gov intervention name — accepted as the source's own label 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 ↗ |