REQUEST FOR PROPOSAL for Study Phase 1 to evaluate the effect of Zoliflodacin on human testicular function, following the US FDA Guidance on Testicular Toxicity.
Closing date: 12.02.2026
ABOUT GARDP FOUNDATION
The Global Antibiotic Research & Development Partnership (GARDP Foundation) is a not-for-profit global health organization registered in Geneva, Switzerland. GARDP’s mission is to accelerate the development and access of treatments for drug-resistant bacterial infections. It does so by forging public-private partnerships all over the world to develop and expand access to treatments for serious bacterial infections and sepsis in adults, children and newborns, as well as sexually transmitted infections (STIs).
GARDP Foundation responds to the crisis in antimicrobial resistance. In 2015, the World Health Assembly, the decision-making body of the World Health Organization (WHO), adopted the Global Action Plan on Antimicrobial Resistance. The following year, to deliver on this plan, WHO and the Drugs for Neglected Diseases initiative created GARDP. In 2018, the GARDP Foundation was legally established as an independent entity.
Since then, GARDP Foundation has developed a portfolio of antibiotic treatments that targets WHO priority pathogens, priority diseases and key populations/regions that are especially affected by drug resistance. It is also pioneering new access initiatives with innovator, manufacturing and distribution partners.
As of 2025, the GARDP team consists of about 100 people who collectively share extensive cross-sector R&D and access experience. They work with the key public and private sector stakeholders and partners, such as the research and development community, donors, industry and implementing countries.
PROJECT BACKGROUND & PURPOSE OF THE RFP
Background to project:
On 12 December 2025, the US FDA approved Nuzolvence® (zoliflodacin), a first-in-class oral antibiotic for gonorrhoea developed by GARDP and Innoviva Specialty Therapeutics (IST) for the treatment of uncomplicated urogenital gonorrhoea in adults and pediatric patients 12 years of age and older, weighing at least 35 kg.
This is the first new treatment solely for gonorrhoea in decades 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).
Purpose of RFP:
The purpose of this Request for Proposal (RFP) is to solicit detailed proposals from qualified Contract Research Organizations (CROs) for the management and execution of that clinical study as per protocol synopsis and service specifications. The RFP aims to identify a CRO with the expertise, resources, and capability to deliver high-quality services that ensure the study’s success.
If you are interested to receive the complete documentation, please review, complete and sign that attached confidential framework and send it to: RFP_Procurement@gardp.org.
Due/closing date: February 12th, 2026