Olorofim
Sponsors
F2G Limited, F2G Biotech GmbH, Fariba Donovan
Conditions
Coccidioidal MeningitisHealthyHepatic ImpairmentInvasive AspergillosisInvasive Fungal InfectionsInvasive fungal infections due to Aspergillus spp.Renal Impairment
Phase 1
Absorption, Metabolism and Excretion of 14C-olorofim in Man
CompletedNCT04039880
Start: 2019-07-30End: 2019-09-30Updated: 2019-11-13
Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim
CompletedNCT04171739
Start: 2019-11-18End: 2020-02-11Updated: 2020-07-24
A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim
CompletedNCT04207957
Start: 2019-12-05End: 2020-09-15Updated: 2021-01-08
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment
CompletedNCT04752540
Start: 2021-07-02End: 2021-10-24Updated: 2022-03-16
A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment
CompletedNCT05200286
Start: 2022-02-10End: 2022-12-13Updated: 2023-01-20
Phase 2
Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
CompletedNCT03583164
Start: 2018-06-06End: 2023-02-10Updated: 2024-07-10
Olorofim in Early Coccidioidal Meningitis
Not yet recruitingNCT07385638
Start: 2026-03-15End: 2027-06-15Target: 12Updated: 2026-02-04
Phase 3
Olorofim Aspergillus Infection Study
Active, not recruitingNCT05101187
Start: 2022-03-31End: 2026-11-01Target: 225Updated: 2026-01-06
A Phase III, adjudicator-blinded, randomised study to evaluate the efficacy and safety of treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with invasive fungal disease (IFD) caused by Aspergillus species
Active, not recruitingCTIS2024-513030-38-00
Start: 2022-02-15Target: 64Updated: 2025-11-26