NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Jun 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEMDRI (plazomicin) is an intravenous aminoglycoside antibiotic approved in June 2018 for treating complicated urinary tract infections caused by susceptible gram-negative bacteria. It represents a novel aminoglycoside with a mechanism of action targeting bacterial protein synthesis. The drug addresses unmet need in resistant gram-negative infections where conventional aminoglycosides have limited efficacy.
Peak5.6 years to LOE
The product is in peak lifecycle stage with established hospital formulary presence; commercial teams focus on maintaining usage in specialized/infectious disease settings with stable but limited market penetration.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Plazomicin Study in ESRD Patients Receiving IHD
Started Jan 2021
6 enrolled
End Stage Renal Disease
A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)
Started Sep 2014
69 enrolled
Bloodstream Infections (BSI) Due to CREHospital-Acquired Bacterial Pneumonia (HABP) Due to CREVentilator-Associated Bacterial Pneumonia (VABP) Due to CRE+2 more
Career Relevance
ZEMDRI offers career opportunities for professionals targeting specialty/hospital antibiotic markets with deep payer and prescriber engagement requirements. This is a niche, technically sophisticated product ideal for those seeking intensive infection control and hospital formulary expertise rather than high-volume primary care experience.
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.