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plazomicin

Trade name: Zemdri

Small moleculeapproved

Approved

Jun 25, 2018

Plazomicin is a novel aminoglycoside antibiotic that binds to the bacterial 30S ribosomal subunit, thus inhibiting protein synthesis in a concentration-dependent manner. Plazomicin displays a broad spectrum of activity against aerobic gram-negative bacteria including extended-spectrum β-lactamase-producing Enterobacteriaceae, carbapenem-resistant Enterobacteriaceae, and organisms with aminoglycoside-modifying enzymes. Plazomicin resistance in Enterobacteriaceae is via modification of the ribosomal binding site due to expression of 16S rRNA methyltransferases. ZEMDRI (plazomicin) injection for intravenous use is indicated for the treatment of patients 18 years of age or older with Complicated Urinary Tract Infections (cUTI) including Pyelonephritis. — NCATS

Clinical trial activity

10 trials · 5 clinical orgs · 2 marketing orgs

Phase 1
7
Phase 2
3
Phase 3
2
Phase 4
0

Earliest trial started Jan 1, 2009 (NCT00822978)

Timeline

2000s

  1. Jan 1, 2009

    Achaogen, Inc. — Earliest Phase 1 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Achaogen, Inc. — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2014

    Achaogen, Inc. — Earliest Phase 3 Sponsor(trial)

  3. Jun 25, 2018

    Earliest FDA Approval

  4. Jun 25, 2018

    Achaogen, Inc. — NDA Secondary Org

  5. Jun 25, 2018

    Cipla — Marketing Organization

  6. Jun 25, 2018

    Cipla — NDA Secondary Org

  7. Jul 27, 2018

    Achaogen, Inc. — First NDA Organization

  8. Jul 27, 2018

    Achaogen, Inc. — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewJun 25, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CN[C@@H]1[C@@H](O)[C@@H](O[C@H]2[C@@H](C[C@H](N)[C@@H](O[C@H]3OC(CNCCO)=CC[C@H]3N)[C@@H]2O)NC(=O)[C@@H](O)CCN)OC[C@]1(C)O
Mol. weight
592.6828 g/mol
Lipinski Ro5
3 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • 6'-(hydroxylethyl)-1-(haba)-sisomicin
  • achn490
  • achn 490
  • achn-490
  • achn-490
  • achn-490
  • achn-490
  • plazomicin
  • plazomicin
  • plazomicin
  • plazomicin
  • plazomicin
  • plazomicin sulfate
  • plazomicin sulfate

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04699656Phase 1Jan 5, 2021Cipla
NCT03270553Phase 1Aug 31, 2017Achaogen, Inc.
NCT03177278Phase 1Jun 6, 2017Achaogen, Inc., Celerion
NCT02486627Phase 3Jan 1, 2016Achaogen, Inc.
NCT01970371Phase 3Sep 1, 2014Achaogen, Inc., Department of Health and Human Services
NCT01514929Phase 1Oct 1, 2011Achaogen, Inc., Department of Health and Human Services
NCT01462136Phase 1Sep 1, 2011Achaogen, Inc., Department of Health and Human Services
NCT01096849Phase 2Mar 1, 2010Achaogen, Inc.
NCT01034774Phase 1Jan 1, 2010Achaogen, Inc.
NCT00822978Phase 1Jan 1, 2009Achaogen, Inc., Jasper Clinic, Inc.
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (5)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Achaogen, Inc.For profit9932009
Department of Health and Human ServicesGovernment3022011
CelerionFor profit1012017
CiplaFor profit1112021
Jasper Clinic, Inc.For profit1012009
5 organizations
Page 1 / 1

Marketing (4)

OrganizationOrg typeRelationshipDate
Achaogen, Inc.For profitNDA2Jun 25, 2018
Achaogen, Inc.For profitNDAJul 27, 2018
CiplaFor profitMKTGJun 25, 2018
CiplaFor profitNDA2Jun 25, 2018