As 2025 draws to a close, we find ourselves at a defining moment in GARDP’s history. This year marks the culmination of nearly a decade of hard work, collaboration and belief in a vision that many once thought impossible: that a non-profit model could drive the development and delivery of desperately needed antibiotics. This year, that vision became reality. The first of GARDP’s medicines, zoliflodacin, received FDA approval, a milestone that stands not only as a scientific achievement but as proof that a new model for antibiotic innovation and access can work.

Zoliflodacin’s approval, together with the forthcoming publication of the pivotal phase 3 study in The Lancet, is far more than the success of a single drug, or of the incredible work of GARDP’s Sexually Transmitted Infections (STI) team. It represents the efforts of hundreds of people across the world—scientists, clinicians, funders, partners, and communities—who worked side by side to advance this novel, first-in-class antibiotic for the treatment of uncomplicated gonorrhoea at a time when resistance has become a global public health threat. With this milestone, GARDP has taken a major step toward ensuring that effective treatments reach those who need them most, wherever they live.

The approval of zoliflodacin, which will be branded under the name Nuzolvence®, shows that a public-private partnership R&D model can bring a new drug from concept through clinical trials and regulatory review while embedding equitable access from the outset. It is a transformative moment—for GARDP, for our partners, and for the global response to antimicrobial resistance (AMR).

In 2025, we also saw significant progress across GARDP’s portfolio. Earlier in the year, even before zoliflodacin was submitted to the FDA, we took an important step towards evaluating the need to expand the treatment options for gonorrhoea, with the signing of an MoU with Swiss-based Debiopharm. By mid-2025, we had made progress towards expanding our portfolio further, by successfully acquiring an exclusive license for the intellectual property for apramycin from the University of Zürich. This, together with the acquisition of all previous data generated on this previously overlooked antibiotic, will help GARDP to potentially repurpose apramycin into a low-cost antibiotic for treating carbapenem-resistant infections.

GARDP and partners have also now begun to lay the groundwork to enable appropriate access to its pathfinder treatment, cefiderocol, in a range of low- and middle-income countries (LMICs). An example of this is the launch of a new project with Shionogi and the Kenya Ministry of Health which aims to introduce cefiderocol in select Kenyan hospitals. GARDP is also engaging with stakeholders in India, South Africa and Brazil to integrate cefiderocol into regular clinical practice in public healthcare systems.

South Africa is also the first country in which GARDP has now launched the next phase of its NeoSep1 trial. With the process of recruiting newborns already underway, this marks the first step in the expansion of this international effectiveness and safety trial to a number of countries in sub-Saharan Africa and Asia. The first baby was enrolled in June at Tygerberg Hospital in Cape Town, South Africa, and by 2028 more than 3,000 others are expected to follow.

Finally, it is also worth mentioning an expansion of our agreement with Bugworks, who we are already working with on the development of the intravenous formulation of BWC0977. In 2025, this was expanded to include the co-development of an oral option, which could offer a much-needed step-down option from the intravenous therapy, which can help to take pressure off health care providers.

All of these exciting developments demonstrate the impressive range in which our model works, and show that it is indeed working! This in turn has helped to generate additional funding from the Government of Japan and raise our visibility on the global AMR stage, with GARDP co-hosting the first ever Global AMR Innovators Conference (GAMRIC) in London in October, together with CARB-X, ESCMID, Life Arc, the Beam Alliance, AMR Solutions and Boston University.

There is of course still plenty of hard work ahead of us, not least with the commercialization of zoliflodacin. But as the holidays approach and as everyone at GARDP takes a much-deserved break, it is worth taking a step back to view the fruit of our labours and see just how far we have come. With the first of our treatments on the verge of becoming a product, I would like to take the opportunity to thank everyone at GARDP for their incredible work and our partners too, upon which this model depends. Together we are showing that there is a new way to tackle AMR, and one that delivers.

Yours sincerely

Manica Balasegaram
Executive Director, GARDP