NDAORALTABLETPriority Review
Approved
Oct 2018
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
17
Data completeness
5/8 — Partial
Priority Review
NUZYRA (omadacycline) by Paratek Pharmaceuticals is 12. First approved in 2018.
Drug data last refreshed 4h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUZYRA (omadacycline) is a tetracycline-class antibacterial approved in October 2018 for oral and intravenous administration. It works by inhibiting bacterial protein synthesis through ribosomal binding, a mechanism common to tetracycline-class agents. The drug is indicated for community-acquired bacterial infections in adult patients.
Peak11.1 years to LOE
Product is in peak commercial phase with established market presence; team size and investment likely stable but monitor for competitive pressure from newer tetracyclines.
Mechanism of Action
12.1 Mechanism of Action NUZYRA is an antibacterial drug [see ]. 12.2 Pharmacodynamics Cardiac Electrophysiology Based on the nonclinical and clinical data, including electrocardiogram evaluation in the phase 3 clinical trials, one of which had moxifloxacin as a control group, no clinically…
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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.