Zoliflodacin.
The first new treatment solely for gonorrhoea.
Zoliflodacin is a new first-in-class single-dose, oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea. It is the first new treatment solely for gonorrhoea and the first to be developed using a novel not-for-profit approach to antibiotic research and development (R&D) aimed at tackling the rise and spread of antimicrobial resistance (AMR).
Neisseria gonorrhoeae has developed resistance to almost all antibiotics used to treat it, with only one last remaining recommended antibiotic treatment, ceftriaxone. Now we are seeing resistance even to this, with a six-fold increase of these kinds of resistant infections in some regions in recent years. Without new and effective antibiotics, like zoliflodacin, gonorrhoea is in danger of becoming one of the first diseases to become once again untreatable because of AMR.
What is zoliflodacin and how does it work?
Zoliflodacin belongs to a new class of antibiotics, called spiropyrimidinetriones, which has a unique mechanism of action. This inhibits a crucial bacterial enzyme called type II topoisomerase, which is essential for bacterial function and reproduction.
GARDP’s investment in zoliflodacin.
Zoliflodacin was developed as part of a public-private partnership between GARDP and Innoviva Specialty Therapeutics, and approved by the US Food and Drug Administration (FDA) in December 2025, under the brand name Nuzolvence®.
Zoliflodacin’s approval followed the positive results of a pivotal phase 3 clinical trial – the largest ever conducted for a new gonorrhoea treatment – that was sponsored and led by GARDP. Previous in vitro studies have shown that zoliflodacin is active against multidrug-resistant strains of Neisseria gonorrhoeae, including those resistant to ceftriaxone and azithromycin, with no cross-resistance with other antibiotics.
GARDP has the right to register and commercialize zoliflodacin in more than three quarters of the world’s countries, including all low-income countries, most middle-income countries and several high-income countries. Entasis Therapeutics, Inc., the original license holder and an affiliate of Innoviva Specialty Therapeutics, retains the commercial rights for zoliflodacin in the major markets in North America, EU and Asia-Pacific.
The potential impact
The positive findings for zoliflodacin establish a proof-of-concept and pave the way for a new not-for-profit R&D model in the global fight against AMR based on public health need. This reflects a broad range of activities undertaken across the development and access pathway, including the full phase 3 trial involving nearly 1,000 patients across five countries; the pharmaceutical development of the final formulation of the drug; the preparation of the regulatory submission to the US FDA; registration in at least two priority countries, Thailand and South Africa; future access activities; chemistry, manufacturing and controls (CMC); campaign formulation improvement; cost of goods (COGS) reduction activities; and future expansion of the safety database in specific populations, such as breastfeeding women.
Where does the project stand?
Following the approval of zoliflodacin by the US FDA, GARDP is working with partners to obtain market authorization in other countries, including initially Thailand and South Africa. These countries were selected not only because they are important partners for GARDP, but also because they played a key role in the phase 3 trial. At the same time, it is working with partners to advance filings with the European Medicines Agency.
In early January 2026, its submission for priority review by the FDA in Thailand was accepted, with an upcoming submission in South Africa. GARDP is committed to generating more data, where required, to support expanded access to zoliflodacin. Furthermore, to make sure zoliflodacin is used appropriately and to delay the emergence of resistance, GARDP is generating real-world evidence – from prevalence and surveillance studies, to patient journey mapping and resistance modelling – all aimed at guiding its optimal use and protecting its lifespan.
Key milestones
Signed
2017 – GARDP signed a collaboration agreement with Entasis Therapeutics Inc. (now Innoviva Specialty Therapeutics) to develop and register zoliflodacin.
EnrollED
2019 – Patients enrolled at all sites in phase 3 trial of zoliflodacin.
Announced
November 2023 – Topline data for phase 3 trial.
Published
December 2025 – Positive results of the phase 3 trial published in The Lancet. 930 participants across 16 trial sites within five countries in four continents – including Belgium, the Netherlands, South Africa, Thailand and the US – took part in the trial.
Approved
December 2025 – NUZOLVENCE® (Zoliflodacin) received US FDA approval.
In progress
December 2025 – Zoliflodacin dossier accepted for priority review in Thailand.
Resources
Evaluation of Drug–Drug Interaction Potential Between the Oral Antibiotic Zoliflodacin and the CYP3A4 Inhibitor Itraconazole: A Phase 1 Study in Healthy Participants
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Zoliflodacin versus ceftriaxone plus azithromycin for treatment of uncomplicated urogenital gonorrhoea: an international, randomised, controlled, open-label, phase 3, non-inferiority clinical trial
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