Olorofim
Sponsors
F2G Limited, F2G Biotech GmbH, F2G Ltd, Fariba Donovan
Conditions
Coccidioidal MeningitisCoccidioides Immitis InfectionCoccidioides InfectionCoccidioides Posadasii InfectionCoccidioidomycosisCoccidioidomycosis InfectionDisseminated Fungal InfectionHealthy
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
RecruitingNCT07385638
Start: 2026-06-01End: 2027-06-15Target: 12Updated: 2026-07-27
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
Not yet recruitingNCT07712484
Start: 2026-12-01End: 2028-07-01Target: 50Updated: 2026-09-22
Phase 3
Olorofim Aspergillus Infection Study
CompletedNCT05101187
Start: 2022-04-29End: 2026-03-19Updated: 2026-10-08
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