SAMRC Welcomes FDA Approval of First-in-Class Oral Antibiotic for Gonorrhoea, Highlights South Africa’s Contribution to Global Breakthrough

The South African Medical Research Council (SAMRC) has welcomed the announcement by the Global Antibiotic Research & Development Partnership (GARDP) that the United States Food and Drug Administration (FDA) has approved NUZOLVENCE® (zoliflodacin), a first-in-class, single-dose oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea.

This historic approval marks the first new antibiotic developed exclusively for gonorrhoea in decades and represents a significant advance in the global fight against antimicrobial resistance (AMR), one of the most pressing public health threats of our time.

The SAMRC takes great pride in its critical role in supporting the zoliflodacin project and the pivotal Phase 3 clinical trial that underpinned this approval. Through strategic investment and scientific collaboration, the SAMRC helped enable high-quality, globally relevant clinical research to be conducted in South Africa, ensuring that evidence is generated in settings with a high burden of disease.

South Africa was one of five countries participating in the landmark Phase 3 trial, which enrolled 930 participants across 16 sites worldwide. The SAMRC’s HIV and Infectious Diseases Research Unit (HIDRU) in Durban formed part of the trial network, contributing valuable data and reinforcing the country’s standing as a trusted partner in large-scale, complex clinical research.

Congratulating GARDP on this milestone, SAMRC President and Chief Executive Officer, Professor Ntobeko Ntusi, said: “Congratulations to GARDP. This is such an important advance that I am certain will change the management landscape for urogenital gonorrhoea. We take such great pride in our association with GARDP and its purpose.”

Gonorrhoea continues to pose a major public health challenge globally, with rising resistance to existing treatments threatening to make the infection increasingly difficult, and in some cases impossible, to treat. Zoliflodacin offers renewed hope, particularly as resistance to the current last-line therapies continues to emerge.

“The approval of zoliflodacin demonstrates the power of equitable global partnerships and the importance of investing in research capacity in low- and middle-income countries,” Professor Ntusi added. “The SAMRC remains committed to supporting research that not only advances scientific knowledge, but also delivers tangible health benefits for South Africans and communities worldwide. SAMRC is grateful to the participants and community partners who have contributed to the advancement of science through their active participation and support of research.”

GARDP has indicated that regulatory submissions are planned for South Africa in early 2026. The SAMRC looks forward to continued collaboration with partners to support access to this important new treatment and to strengthen South Africa’s contribution to global solutions against antimicrobial resistance.

To access GARDP full Press Release, click here.

To access the Lancet Article, click here.