GARDP Annual Report 2025
Turning vision into reality
Turning vision into reality
Find out about GARDP’s impact in 2025, with commentary from our Executive Director and Board Chair, reports from our projects and partnerships, and a review of our finances.
“In 2025, GARDP reached a defining milestone – turning a long-held vision into reality. The US FDA’s approval of zoliflodacin shows what a public health–driven model can deliver, and proves that innovation and equitable access can advance together.”
— Dr Manica Balasegaram, GARDP Executive Director, and Prof Glenda Gray, GARDP Board Chair
Amid a turbulent year for global health, this annual report highlights major progress in developing and expanding access to treatments for priority pathogens. From advances in R&D to the formation of promising new partnerships across sectors, it shows how GARDP is shaping a more sustainable model for antibiotic development. 2025 also marked the culmination of the 5 BY 25 initiative – providing the critical foundations for the GARDP portfolio today while generating important learnings that will help replenish the antibiotic pipeline for the future.
Highlights
Highlights
The past year marked a defining moment in GARDP’s mission to tackle antimicrobial resistance, anchored by the first regulatory approval of a treatment from GARDP’s portfolio, continued pipeline expansion, and significant progress to advance access to key treatments in high-burden countries.
A first regulatory approval. In December, the US FDA approved NUZOLVENCE® (zoliflodacin) — the first new treatment developed specifically for gonorrhoea in decades, and the first treatment from GARDP’s portfolio to receive regulatory approval. The approval closed a treatment gap of more than thirty years and proved the viability of a not-for-profit drug development model focused on public health needs.
An expanding pipeline against the deadliest pathogens. GARDP secured the human-use rights to apramycin, an affordable, broad-spectrum candidate treatment for drug-resistant Gram-negative infections. The BWC0977 intravenous formulation entered Phase 1 clinical trials with partner Bugworks, while a new agreement was reached to co-develop an oral formulation suited to outpatient treatment in low- and middle-income countries. Drug discovery projects expanded through partnerships including ENABLE-2, the European Gram-Negative Antibacterial Engine.
A second gonorrhoea treatment in the pipeline. Because Neisseria gonorrhoeae has historically developed resistance to nearly all available treatments, maintaining a diverse pipeline is essential. GARDP laid the foundations for a new partnership with Debiopharm to advance the promising compound Debio 1453, supported by CARB-X, pending outcomes of its Phase 1 clinical trial.
Progress on sustainable access to effective treatments. GARDP advanced the introduction of the Reserve antibiotic cefiderocol in Kenya in partnership with Shionogi and the Ministry of Health. With Orchid Pharma in Chennai, the first engineering batches of cefiderocol were successfully manufactured – a proof-of-concept step for sustainable and affordable production. Enrolment began in the second part of NeoSep1, a major clinical trial to identify effective treatments for neonatal sepsis, now set to expand to nine countries over the coming years.
Connecting the AMR community. GARDP co-hosted the first Global AMR Innovators Conference (GAMRIC) in London, bringing together more than 300 public health leaders, scientists, policymakers, and funders. The REVIVE platform also expanded its expert network and open-access resources for researchers working on antibiotic R&D worldwide.
Financial commitment
Financial commitment
In 2025, GARDP’s expenditure reached €32 million, up from €26.1 million in 2024, responding to the planned expansion of the portfolio and key activities relating to neonatal sepsis and regulatory submissions of zoliflodacin. New financial pledges and commitments were secured from the European Commission’s DG HERA (€13.75M), the UK’s Global AMR Innovation Fund (£5.2M), the Japanese Ministry of Health, Labour and Welfare (USD $1M), the Global Health EDCTP3 Joint Undertaking (€0.75M), and the Swiss State Secretariat for Education, Research and Innovation (CHF 0.8M) – adding to the €60M committed in 2024.
From vision to reality
From vision to reality
Every year, 82 million people contract gonorrhoea – and the bacteria that causes it has developed resistance to almost every antibiotic ever used against it. Before zoliflodacin’s approval in December 2025, only one effective treatment remained.
The approval is the result of more than a decade of work in close partnership with public funders, clinical trial sites in low- and middle-income countries, and Innoviva Specialty Therapeutics, the commercial partner. Within weeks of the US approval, regulatory submissions had already been filed in Thailand, with South Africa expected to follow.
Zoliflodacin’s approval demonstrates the strength of GARDP’s not-for-profit drug development model: designing treatments to reach the populations most affected by resistance, and integrating access considerations from the earliest stages of R&D. It is not the end of the journey, bur rather proof that the journey can be done.
GARDP’s next chapter – shaped by our upcoming five-year strategy for 2027–2031, currently in development – will go further still. We will expand our work to tackle difficult-to-treat Gram-negative bacteria and sexually transmitted infections. We will increase treatment options for populations long overlooked in R&D, especially children, while supporting sustainable country-level introductions. And we will continue to strengthen our discovery portfolio and leverage strategic alliances to drive innovation where commercial incentives fall short.