NUZOLVENCE
Launchzoliflodacin
NDAORALFOR SUSPENSIONPriority Review
Approved
Dec 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
4
Data completeness
3/8 — Basic
Priority Review
Drug data last refreshed 10h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NUZOLVENCE (zoliflodacin) is a novel oral suspension antibiotic approved in December 2024. Specific indications and mechanism of action are not fully detailed in available data, but the drug represents a new chemical entity in the fluoroquinolone or related antibiotic class. This oral formulation suggests utility in treating bacterial infections where convenient dosing and systemic absorption are clinically advantageous.
Launch7.3 years to LOE
As a newly launched oral antibiotic with minimal competitive pressure, early-stage commercial teams will focus on market penetration and prescriber education, creating growth opportunities in field sales and brand management roles.
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 (4)
Zoliflodacin Bioequivalence and Drug-Drug Interaction Study
Started Nov 2022
50 enrolled
Healthy Volunteers
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
Started Oct 2018
48 enrolled
Gonorrhea
Thorough QT/QTC (TQT) Clinical Trial to Evaluate the Effect of Zoliflodacin on Cardiac Repolarization in Healthy Male and Female Subjects
Started Sep 2018
72 enrolled
Electrocardiogram Repolarisation AbnormalityGonococcal Infection
A Study to Evaluate the Safety, Tolerability and Plasma PK of a Single Oral Dose of Zoliflodacin in Healthy Male and Female Volunteers
Started Feb 2018
8 enrolled
Gonorrhoea
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.