Zoliflodacin is a novel oral treatment that is in clinical development for the treatment of uncomplicated urogenital gonorrhea, with a specific focus on infections resistant to the current standard of care antibiotics (ceftriaxone and/or azithromycin). The development of Zoliflodacin is a partnership between GARDP and Innoviva Specialty Therapeutics (IST, formerly Entasis). GARDP currently holds the license for 150 countries globally, predominantly low- and middle-income countries (LMICs) and IST hold the license in US, Europe, Japan and China amongst others. The global phase III clinical trial has been conducted in 5 countries (Thailand, South Africa, Belgium, Netherlands, and United States).

Zoliflodacin is currently in phase 3 with data read out in November 2023 with the aim of FDA approval in 2025. GARDP wish to implement a Managed Access Program that will support access to Zoliflodacin on a free-of charge basis prior to approval across a number of countries globally with the potential to expand this over time.

If you are interested to receive complete documentation of this RFP, please send a request to: RFP_Procurement@gardp.org.

Closing date: November 20th 2023