Nuzolvence

Nuzolvence is used to treat uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae in adults and children aged 12 and older, weighing at least 77 pounds (35 kg). Nuzolvence (zoliflodacin) is a prescription antibacterial oral suspension administered as a single oral dose. It can be used for patients allergic to penicillin or related drugs.

Nuzolvence (zoliflodacin) gained FDA approval on December 12, 2025, and is expected to be available late 2026.

Nuzolvence works by inhibiting a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction. Laboratory studies of zoliflodacin have demonstrated activity against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance to other antibiotics.

Nuzolvence (zoliflodacin) belongs to the drug class called spiropyrimidinetrione bacterial type II topoisomerase inhibitors and was the first in its class to be developed.

Read the Instructions for Use leaflet for information about the right way to take Nuzolvence.

• Always mix Nuzolvence with water before taking.
• Do not mix Nuzolvence with other liquids or sprinkle it on food.
• Drink Nuzolvence within 15 minutes after mixing. If Nuzolvence is not taken within 15 minutes, do not take it and call your healthcare provider for a new dose.
• Take Nuzolvence exactly as your healthcare provider tells you.
• If you do not or cannot take the full dose, call your healthcare provider right away.

Based on your weight, take Nuzolvence as follows:

• If you weigh between 77 pounds (35 kg) and less than 110 pounds (50 kg): Take Nuzolvence on an empty stomach, 1 hour before eating or 2 hours after eating.
• If you weigh greater than or equal to 110 pounds (50 kg): Take Nuzolvence with food.

Absolute contraindications

Do not take Nuzolvence if you:

• Have a history of being allergic to Nuzolvence, zoliflodacin, or any of the ingredients in the unit-dose packets (see the end of this guide for a list of ingredients).
• Are taking certain medicines called CYP3A4 inducers, which increase the enzyme CYP3A4 in your liver (examples include rifampin, St. John’s Wort, carbamazepine, phenytoin, and dexamethasone). These medicines can make Nuzolvence less effective. Ask your healthcare provider or pharmacist if you are not sure if you take CYP3A4 inducers.

Caution needed

Before taking Nuzolvence, tell your healthcare provider about all of your medical conditions, including if you:

• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Pregnancy

It is not known if Nuzolvence can harm your unborn baby. See serious side effects and warnings above.

• Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Nuzolvence.

Pregnancy Safety Study: There is a pregnancy safety study for women who are exposed to Nuzolvence during pregnancy. The purpose of this registry is to check the health of you and your baby. If you are pregnant while being treated, you or your healthcare providers should report the pregnancy to Entasis Therapeutics at 1-800-651-3861.

Breastfeeding

It is not known if Nuzolvence passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby after taking Nuzolvence.

Common Side Effects

The most common side effects of Nuzolvence are:

• Low white blood cell count
• Headache
• Dizziness
• Nausea
• Diarrhea.

Serious side effects and warnings

Nuzolvence may cause the following serious side effects.

Fetal harm

It is not known if Nuzolvence can harm your unborn baby.

• Females: Your healthcare provider should have you take a pregnancy test before you receive Nuzolvence. If you take Nuzolvence while you are pregnant, your baby may be at risk for serious birth defects.
• Males: Males with female partners who can become pregnant should use effective contraception for at least 90 days (3 months) after treatment with Nuzolvence.

Harm to testicles

Nuzolvence may be harmful to testicles and lower sperm count in males and cause fertility problems. Nuzolvence may harm your sperm.

Allergic reactions

Allergic reactions, including rash and itching, have been reported in people receiving Nuzolvence.

Diarrhea caused by Clostridioides difficile infection

Antibiotics can sometimes cause a type of severe diarrhea called C. difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can be serious or life-threatening. CDI can happen up to 2 months after finishing treatment with Nuzolvence. Call your healthcare provider right away if you develop frequent, watery, or bloody stools, or stomach cramps that are severe, do not go away, or come back, after taking Nuzolvence.

It is not known if Nuzolvence is safe and effective in children younger than 12 years of age or who weigh less than 77 pounds (35 kg).

These are not all the possible side effects of Nuzolvence. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

FDA approval for Nuzolvence was based on a phase 3 clinical trial (NCT03959527) of 930 patients with uncomplicated gonorrhea, which compared single-dose zoliflodacin 3g against standard dual therapy (ceftriaxone plus azithromycin).

• Zoliflodacin showed noninferiority with 90.9% cure rate versus 96.2% for standard treatment at urogenital sites.
• The trial included patients aged 12+ weighing at least 35kg, with microbiological response assessed 6 days post-treatment.

Dose of Nuzolvence for Uncomplicated Gonorrhea in Adults and Children ≥12 years weighing ≥35kg

• 3 grams (one packet) orally
• Administer as a single dose
• Administer within 15 minutes of mixing; prepare new dose if not given within this timeframe.

Administration:

• Patients 35-<50kg: Take on an empty stomach (1 hour before or 2 hours after food)
• Patients ≥50kg: Take with food

Tell your healthcare provider about all the medicines you take, including prescription and over-the counter medicines, vitamins, and herbal supplements. Especially tell them if you take:

• CYP3A4 inducers such as rifampin, St. John’s Wort, carbamazepine, phenytoin, and dexamethasone. These medicines can make Nuzolvence less effective.

These are not all the possible interactions with Nuzolvence. See the Nuzolvence prescribing Information for a full list.

Store Nuzolvence at room temperature between 68 °F and 77 °F (20 °C and 25 °C) in the original packaging.

Do not freeze.

Keep out of the reach of children.

Active ingredient: zoliflodacin

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, talc, and xanthan gum.

Supplied as 3 g of zoliflodacin in each unit-dose packet for oral suspension.

Nuzolvence is manufactured for Innoviva Specialty Therapeutics, Inc., and is a trademark of Entasis Therapeutics, Inc.