CLINICAL TRIALS PROFILE FOR OLOROFIM

Clinical Trials for Olorofim

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03583164 ↗	Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options	Recruiting	IQVIA	Phase 2	A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
NCT03583164 ↗	Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options	Recruiting	Iqvia Pty Ltd	Phase 2	A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
NCT03583164 ↗	Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options	Recruiting	F2G Biotech GmbH	Phase 2	A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
NCT03583164 ↗	Evaluate F901318 Treatment of Invasive Fungal Infections in Patients Lacking Treatment Options	Recruiting	F2G Ltd.	Phase 2	A study to evaluate F901318 (study drug) for the treatment of invasive fungal infections in patients lacking suitable alternative treatment options.
NCT04039880 ↗	Absorption, Metabolism and Excretion of 14C-olorofim in Man	Completed	PRA Health Sciences	Phase 1	Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg [14C]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).
NCT04039880 ↗	Absorption, Metabolism and Excretion of 14C-olorofim in Man	Completed	F2G Biotech GmbH	Phase 1	Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg [14C]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).
NCT04039880 ↗	Absorption, Metabolism and Excretion of 14C-olorofim in Man	Completed	F2G Ltd.	Phase 1	Single-centre, open-label, non-randomised, single dose study in 2 cohorts of healthy subjects. It is planned to enrol 6 healthy male subjects in Cohort A (standard mass balance and metabolite profiling cohort) and up to 6 subjects in Cohort B (biliary evaluation cohort); each subject will receive a single oral administration of 120 mg [14C]-olorofim oral solution containing approximately 3.7 MBq (100 µCi).

Clinical Trial Conditions for Olorofim

Condition Name

Condition Name for
Intervention	Trials
Healthy	2
Invasive Fungal Infections	2
Hepatic Impairment	1
Invasive Aspergillosis	1

Condition MeSH

Condition MeSH for
Intervention	Trials
Invasive Fungal Infections	2
Mycoses	2
Infections	1
Infection	1

Clinical Trial Locations for Olorofim

Trials by Country

Trials by Country for
Location	Trials
United States	13
United Kingdom	5
Brazil	4
Australia	4
France	4

Trials by US State

Trials by US State for
Location	Trials
Florida	2
California	2
Texas	1
Pennsylvania	1
North Carolina	1

Clinical Trial Progress for Olorofim

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1	5

Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase	Trials
Completed	3
Not yet recruiting	2
Recruiting	2

Clinical Trial Sponsors for Olorofim

Sponsor Name

Sponsor Name for
Sponsor	Trials
F2G Biotech GmbH	7
F2G Ltd.	5
Iqvia Pty Ltd	2

Sponsor Type

Sponsor Type for
Sponsor	Trials
Industry	17
Other	1