Zoliflodacin Holds Gonorrhea Cure Rates in Chlamydia Coinfected Patients

New data scheduled for presentation October 24 at IDWeek 2026, in Washington, DC, show zoliflodacin (Nuzolvence; Innoviva Specialty Therapeutics) maintains high rates of microbiologic eradication of urogenital Neisseria gonorrhoeae in patients co-infected with Chlamydia trachomatis. Nearly 1 in 4 participants in the urogenital evaluable population tested positive for chlamydia, and gonorrhea cure rates were similar regardless of chlamydia status.¹ “Antimicrobial resistance remains one of the most urgent global health challenges, requiring continued innovation and rigorous evidence generation,” said David Altarac, MD, chief medical officer at Innoviva Specialty Therapeutics.³

The FDA approved zoliflodacin in December 2025 as a first-in-class, single-dose oral antibiotic for uncomplicated urogenital gonorrhea in adults and pediatric patients 12 years and older weighing at least 35 kg.³ In the global phase 3 trial supporting approval, 930 participants were randomly assigned 2:1 to a single 3-g oral dose of zoliflodacin or ceftriaxone 500 mg intramuscularly plus azithromycin 1 g orally. Urogenital microbiologic cure rates in the microbiologic intention-to-treat population were 90.9% (460/506) with zoliflodacin and 96.2% (229/238) with the comparator, meeting the prespecified 12% noninferiority margin.²

Urogenital C trachomatis co-infection was detected by nucleic acid amplification testing in 235 (25%) of 923 phase 3 participants.² Because the comparator regimen included azithromycin, which is also active against chlamydia, the new analysis addresses whether concurrent chlamydial infection affects zoliflodacin activity against N gonorrhoeae when the drug is given alone.¹

In the following interview, Altarac discusses what the findings mean for co-infected patients, how clinicians should manage chlamydia alongside zoliflodacin.

Contagion: Gonorrhea cure rates were similar with or without chlamydia co-infection. What does this tell clinicians about zoliflodacin’s performance in co-infected patients?

Altarac: Nuzolvence, or zoliflodacin, is a first-in-class single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhea. The data being presented at IDWeek demonstrate that concomitant chlamydial infection does not compromise zoliflodacin’s activity against gonorrhea. It is important to remember, though, that these are 2 separate infections. Zoliflodacin treats uncomplicated urogenital gonorrhea, and patients with chlamydial infections should receive the proper antibiotic therapy.

Contagion: Because the comparator included azithromycin, which also treats chlamydia, how should clinicians handle possible or confirmed chlamydia co-infection when prescribing zoliflodacin?

Altarac: Zoliflodacin is approved for uncomplicated urogenital gonorrhea and is not approved for chlamydial infections. A single-dose oral cure for gonorrhea is a massive win, but it does not erase the clinical need to diagnose and treat coexisting sexually transmitted infections, including chlamydia. Clinicians must continue to test for chlamydia and manage it independently, using standard recommended chlamydial regimens.

Contagion: How do you see zoliflodacin fitting alongside current CDC guidance?

Altarac: Given its mode of delivery and unique mechanism of action, it offers a new tool in addressing a critical public health vulnerability. As the CDC and other agencies like the World Health Organization determine their recommendations, our job is to continue to generate real-world evidence, monitor susceptibility and resistance, and work with the public health community to support appropriate use.

Editor’s Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

REFERENCES:

1. McLeod S et al. Zoliflodacin maintains high rates of microbiologic eradication of urogenital Neisseria gonorrhoeae in patients co-infected with Chlamydia trachomatis. Presented at: IDWeek 2026; October 24, 2026; Washington, DC.

2. Luckey A, Balasegaram M, Barbee LA, et al. Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial. Lancet. 2026;407(10524):147-160. doi:10.1016/S0140-6736(25)01953-1

3. Innoviva Specialty Therapeutics. Innoviva Specialty Therapeutics to present data across infectious disease portfolio at IDWeek 2026. Published October 19, 2026. Accessed October 23, 2026. https://investor.inva.com/news-releases/news-release-details/innoviva-specialty-therapeutics-present-data-across-infectious