Zoliflodacin
NUZOLVENCE
What it isA spiropyrimidinetrione inhibitor of bacterial gyrase B; single-dose oral therapy for uncomplicated urogenital gonorrhea.
Why this oneIt is gonorrhea-specific, unlike gepotidacin’s added urinary-tract indication.
What limits itNausea and diarrhea can limit use; pharyngeal infection responded less reliably in trials, and efficacy should not be extrapolated to rectal infection.
FDA-approved for
- uncomplicated gonorrhea (2025)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Uncomplicated urogenital gonorrhea | Adults & peds >=12 yr weighing >=35 kg | Oral (suspension): 3 g (one packet) x1 single dose | Single dose | 3 g x1 |
Renal Undefined
Hepatic Undefined
Instructions
- Obtain pregnancy test in females of reproductive potential before initiating
- Food by weight: 35 to <50 kg — take on empty stomach (1 h before or 2 h after food); >=50 kg — take with food
- Mix packet in 60 mL water, shake >=60 s to uniform suspension, drink entire contents immediately; add another 60 mL water to same container, shake, and drink to complete the dose
- Administer entire dose within 15 min of mixing — otherwise prepare a new dose
- Do not mix with other liquids, sprinkle on food, or take dry
Contraindications
- Concomitant moderate or strong CYP3A4 inducers (predicted decreased zoliflodacin concentrations; may reduce efficacy)
Cautions
- Embryo-fetal toxicity (animal data: exencephaly, embryo-fetal loss near clinical exposures) — avoid in pregnancy; pregnancy test before use
- Male-mediated embryo-fetal risk — males with female partners of reproductive potential should use effective contraception for >=3 months after the dose
- Testicular toxicity and possible male fertility impairment (animal data; human spermatogenesis not assessed)
- Hypersensitivity reactions (rash, pruritus) — discontinue and treat
- Clostridioides difficile infection — evaluate if diarrhea occurs (may occur >2 months post-antibiotic)
Adverse reactions
- Laboratory: neutropenia 12%, leukopenia 9% (transient, no treatment required)
- Headache 10%, dizziness 3%, nausea 3%, diarrhea 2%
Pregnancy Animal data: fetal malformations (exencephaly) and embryo-fetal loss at exposures 1.6-8.5x MRHD — may cause fetal harm; avoid during pregnancy; obtain pregnancy test before treatment; postmarketing pregnancy safety study available
Lactation No human or animal milk data; intestinal-flora alteration possible in breastfed infant — weigh breastfeeding benefits vs maternal need
NO BOXED WARNINGS
Classes and tags
Clinical profile
Mechanism of action: Zoliflodacin ballicule
