Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options

Summary

A study to evaluate olorofim (F901318) for the treatment of invasive fungal infections in participants lacking suitable alternative treatment options.

Timeline

Start

2018-06-06

Primary completion

2023-02-10

Completion

2023-02-10

Publications

• Cornelissen K, Rex JH, Zinzi D, Law D, Upcott Gill R, Jones HM, Maertens J, Chen SC-A, Bruggemann R. Evaluation of the cytochrome P450-mediated drug interaction profile of olorofim. Antimicrob Agents Chemother. 2026 Jun 3;70(6):e0174525. doi: 10.1128/aac.01745-25. Epub 2026 Apr 20.
• Maertens J, Chen SCA, Thompson GR 3rd, Donovan F, Dane A, Birch M, Pinder C, Bennett J, Ravenna V, Marin Fernandez O, Ross G, Zinzi D, Rex JH; Phase 2b Olorofim Salvage Therapy Study Group. Olorofim in combination with azole antifungals: results from the Phase 2 salvage therapy study. J Antimicrob Chemother. 2026 Mar 4;81(4):dkag118. doi: 10.1093/jac/dkag118.
• Maertens JA, Thompson GR 3rd, Spec A, Donovan FM, Hammond SP, Bruns AHW, Rahav G, Shoham S, Johnson R, Rijnders B, Schaenman J, Hoenigl M, Morrissey CO, Mehta SR, Heath CH, Koehler P, Paterson DL, Slavin MA, Fortun J, Nguyen MH, Patterson TF, Uspenskaya O, Van de Veerdonk FL, Verweij PE, Aoun M, Georgala A, Alexander BD, Chayakulkeeree M, Mehra V, Miceli MH, Sikka MK, Sole A, Walsh TJ, Aguado JM, Holland SM, Moussa M, Rautemaa-Richardson R, Bazaz R, Schwartz S, Walsh SR, Plate M, Yehudai-Ofir D, Bruggemann RJ, Cornely OA, Ostrosky-Zeichner L, Vazquez JA, White PL, Cornelissen K, Ross GG, Fitton L, Dane A, Zinzi D, Rex JH, Chen SC. Olorofim for the treatment of invasive fungal diseases in patients with few or no therapeutic options: a single-arm, open-label, phase 2b study. Lancet Infect Dis. 2025 Nov;25(11):1177-1188. doi: 10.1016/S1473-3099(25)00224-5. Epub 2025 Jun 18.

Drugs

Indications