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 27m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZEMDRI (plazomicin) is an intravenous aminoglycoside antibiotic approved by the FDA in June 2018 for treating complicated urinary tract infections (cUTI), including pyelonephritis, caused by susceptible aerobic gram-negative bacteria. It represents a new-generation aminoglycoside designed to address resistant gram-negative pathogens. The mechanism of action involves inhibition of bacterial protein synthesis through ribosomal binding.
Peak5.9 years to LOE
Product is in peak commercial stage with low ASP ($3.51/unit), suggesting mature market positioning with limited pricing power and stable but not expanding team requirements.
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 presents limited career growth opportunities given zero linked job openings and a mature product in peak lifecycle facing imminent LOE in 5.9 years. Roles in commercial execution, hospital channel management, and formulary access are primary opportunities, but team stability and headcount are likely to contract post-2028.
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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.