Product Description
Plazomicin is a novel semisynthetic parenteral aminoglycoside that inhibits bacterial protein synthesis. It was approved by the United States Food and Drug Administration for use in adults with complicated urinary tract infections (cUTI), including pyelonephritis. Plazomicin displays potent in vitro activity against Enterobacteriaceae, including both extended-spectrum beta-lactamase-producing and carbapenem-resistant isolates. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30723876/)
Mechanisms of Action: 30S Ribosomal Subunit Antagonist,Protein Synthesis Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: United States
Approved Indications: Urinary Tract Infections | Nephritis | Pyelonephritis
Known Adverse Events: Hypertension | Hypotension | Headache | Hypertension, Renal | Diarrhea
Company: Achaogen
Company Location: SOUTH SAN FRANCISCO CA 94080
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Highest Development Phases
Phase 3: Communicable Diseases|Pyelonephritis|Pneumonia|Pneumonia, Bacterial|Urinary Tract Infections|Pneumonia, Ventilator-Associated|Enterobacteriaceae Infections
Phase 2: Communicable Diseases|Urinary Tract Infections|Pyelonephritis
Phase 1: Healthy Volunteers|Kidney Diseases|Kidney Failure, Chronic
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CPH-002-CL-013 | P1 |
Completed |
Kidney Failure, Chronic |
2021-03-08 |
|
| ACHN-490-011 | P1 |
Completed |
Healthy Volunteers |
2017-10-07 |
|
| ACHN-490-010 | P1 |
Completed |
Healthy Volunteers |
2017-07-10 |
|
| EPIC | P3 |
Completed |
Pyelonephritis|Urinary Tract Infections|Communicable Diseases |
2016-09-22 |