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. 2025 Mar 11:15:100624.
doi: 10.1016/j.ijregi.2025.100624. eCollection 2025 Jun.

High susceptibility to the novel antimicrobial zoliflodacin among Neisseria gonorrhoeae isolates in eight WHO Enhanced Gonococcal Antimicrobial Surveillance Programme countries in three WHO regions, 2021-2024

Susanne Jacobsson  1 , Thitima Cherdtrakulkiat  2 , Daniel Golparian  1 , Lon Say Heng  3 , Irving Hoffman  4 , Manuel C Jamoralin Jr  5 , Francis Kakooza  6 , Rossaphorn Kittiyaowamarn  2 , Peter Kyambadde  7 , Pham Thi Lan  8 , Venessa Maseko  9 , Mitch Matoga  4 , Etienne Müller  9 , Thuy Thi Phan Nguyen  10 , Vichea Ouk  11 , Daniel Schröder  1 , Vivi Setiawaty  12 , Sonia B Sia  5 , Verawati Sulaiman  12 , Mot Virak  3 , Nguyen Thi Thuy Van  13 , Ismael Maatouk  14 , Teodora Wi  14 , Magnus Unemo  1   15 ; WHO EGASP zoliflodacin study group
Affiliations

High susceptibility to the novel antimicrobial zoliflodacin among Neisseria gonorrhoeae isolates in eight WHO Enhanced Gonococcal Antimicrobial Surveillance Programme countries in three WHO regions, 2021-2024

Susanne Jacobsson et al. IJID Reg. .

Abstract

Objectives: Zoliflodacin, a novel spiropyrimidinetrione, showed non-inferiority compared with recommended ceftriaxone plus azithromycin treatment in a recent global phase III randomized controlled trial for gonorrhea treatment. We evaluated the susceptibility of zoliflodacin among 2993 contemporary gonococcal isolates collected in 2021-2024 in eight World Health Organization (WHO) Enhanced Gonococcal Antimicrobial Surveillance Programme countries in the WHO Southeast Asian Region (Indonesia, Thailand), WHO Western Pacific Region (Cambodia, the Philippines, Viet Nam), and WHO African Region (Malawi, South Africa, Uganda).

Methods: Minimum inhibitory concentrations (MICs) of zoliflodacin were determined using the agar dilution technique, and the zoliflodacin target gene (gyrB) was examined with Illumina sequencing.

Results: Zoliflodacin exhibited high activity: MICs ranging from 0.001 to 1 mg/l and a modal MIC of 0.032 mg/l. The zoliflodacin MIC distribution showed mostly a wild-type profile; however, two isolates from Cambodia had MICs of 0.5 mg/l and 1 mg/l. These isolates also harbored the GyrB D429N mutation, associated with increased zoliflodacin MICs.

Conclusions: We show a high susceptibility to zoliflodacin internationally, including against ceftriaxone- and azithromycin-resistant gonococcal strains. Our findings support the continued clinical development of zoliflodacin as a treatment for gonorrhea, although cautious and monitored introduction and continuous international resistance surveillance are imperative.

Keywords: Gonorrhea; In vitro susceptibility; Neisseria gonorrhoeae; Treatment; WHO EGASP; Zoliflodacin.

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Conflict of interest statement

The authors have no competing interests to declare.

Figures

Figure 1
Figure 1
Zoliflodacin MIC distribution for WHO EGASP Neisseria gonorrhoeae isolates obtained in 2021 (n = 12), 2022 (n = 945), 2023 (n = 1968), and 2024 (n = 68). EGASP, Enhanced Gonococcal Antimicrobial Susceptibility Programme; MIC, minimum inhibitory concentration; WHO, World Health Organization.
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