American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists · 2026
Zoliflodacin: A novel single-dose oral antibiotic for uncomplicated urogenital gonorrhea.
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Durham Spencer H, Chahine Elias B
Аннотация
PURPOSE: To review the efficacy and safety of zoliflodacin for the treatment of uncomplicated urogenital gonorrhea (uUGG).
SUMMARY: A literature search was performed using PubMed and Google Scholar with the search terms "zoliflodacin," "AZD0914," and "ETX0914." All relevant English-language articles of studies assessing the efficacy and safety of zoliflodacin for the treatment of uUGG were included. Other resources included abstracts presented at recent conferences, the manufacturer's website, and prescribing information. Zoliflodacin is a first-in-class spiropyrimidinetrione antibiotic with a novel mechanism of action and has been shown to be highly active against Neisseria gonorrhoeae, including strains resistant to other antibiotics such as ceftriaxone and azithromycin. It is FDA approved for the treatment of uUGG in adult and pediatric patients aged 12 or older and weighing at least 35 kg and is administered as a one-time oral dose of 3,000 mg. In a large phase 3 trial, zoliflodacin was noninferior to ceftriaxone plus azithromycin for the treatment of uUGG in both men and women and demonstrated a favorable safety and tolerability profile.
CONCLUSION: Zoliflodacin is a newly approved antibiotic with a novel mechanism of action that is highly effective for the treatment of uUGG. It is given as a single dose that can be administered orally at the time of diagnosis, thereby avoiding the intramuscular injection necessary with ceftriaxone. It is also effective against gonorrhea strains resistant to other antibiotics.
SUMMARY: A literature search was performed using PubMed and Google Scholar with the search terms "zoliflodacin," "AZD0914," and "ETX0914." All relevant English-language articles of studies assessing the efficacy and safety of zoliflodacin for the treatment of uUGG were included. Other resources included abstracts presented at recent conferences, the manufacturer's website, and prescribing information. Zoliflodacin is a first-in-class spiropyrimidinetrione antibiotic with a novel mechanism of action and has been shown to be highly active against Neisseria gonorrhoeae, including strains resistant to other antibiotics such as ceftriaxone and azithromycin. It is FDA approved for the treatment of uUGG in adult and pediatric patients aged 12 or older and weighing at least 35 kg and is administered as a one-time oral dose of 3,000 mg. In a large phase 3 trial, zoliflodacin was noninferior to ceftriaxone plus azithromycin for the treatment of uUGG in both men and women and demonstrated a favorable safety and tolerability profile.
CONCLUSION: Zoliflodacin is a newly approved antibiotic with a novel mechanism of action that is highly effective for the treatment of uUGG. It is given as a single dose that can be administered orally at the time of diagnosis, thereby avoiding the intramuscular injection necessary with ceftriaxone. It is also effective against gonorrhea strains resistant to other antibiotics.