12 completed, 5 withdrawn, 1 not yet recruiting, 1 recruiting. 15 Phase 1, 5 Phase 2, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 15 | Completed 10, Withdrawn 5 |
| Phase 2 | 5 | Withdrawn 2, Completed 1, Not yet recruiting 1, Recruiting 1 |
| Phase 3 | 1 | Completed 1 |
Follow olorofim: new trials by email Literature Review of olorofim trials Research Report on olorofim
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| 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 Olorofim, Placebo - Coccidioidomycosis, Disseminated Fungal Infection | Phase 2 | Not yet recruiting | F2G Ltd | 50 | 2026-12-01 | 2026-09-22 |
| Olorofim in Early Coccidioidal Meningitis olorofim - Coccidioidal Meningitis | Phase 2 | Recruiting | Fariba Donovan | 12 | 2026-06-01 | 2026-07-27 |
| Olorofim Aspergillus Infection Study Olorofim, AmBisome® - Invasive Aspergillosis | Phase 3 | Completed | F2G Ltd | 225 | 2022-04-29 | 2026-10-08 |
| A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment Olorofim - Renal Impairment | Phase 1 | Completed | F2G Biotech GmbH | 16 | 2022-02-10 | 2023-01-20 |
| A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment Olorofim - Hepatic Impairment | Phase 1 | Completed | F2G Biotech GmbH | 32 | 2021-07-02 | 2022-03-16 |
| A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim Olorofim - Healthy | Phase 1 | Completed | F2G Ltd | 24 | 2019-12-05 | 2021-01-08 |
| Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim Itraconazole oral solution, Rifampicin Oral Capsule, Olorofim - Healthy | Phase 1 | Completed | F2G Ltd | 24 | 2019-11-18 | 2020-07-24 |
| Absorption, Metabolism and Excretion of 14C-olorofim in Man Olorofim - Invasive Fungal Infections | Phase 1 | Completed | F2G Ltd | 12 | 2019-07-30 | 2019-11-13 |
| Radiolabelled IV and Oral Metabolism Study of F901318 IV F901318, Oral F901318 - Invasive Aspergillosis | Phase 1 | Withdrawn | F2G Ltd | 2019-05-01 | 2019-07-26 | |
| Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options Olorofim - Invasive Fungal Infections | Phase 2 | Completed | F2G Biotech GmbH | 203 | 2018-06-06 | 2024-07-10 |
| Assessment of Varying Oral Dosing Regimens for F901318 in Healthy Subjects F901318 - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 45 | 2017-12-12 | 2018-08-02 |
| Pharmacokinetics of IV Formulation F901318 - Invasive Aspergillosis | Phase 1 | Withdrawn | F2G Ltd | 2017-05-01 | 2017-11-01 | |
| Drug/Drug Interactions With F901318 cyclosporine A, Posaconazole, Pantoprazole - Invasive Aspergillosis | Phase 1 | Withdrawn | F2G Ltd | 2017-05-01 | 2017-11-01 | |
| Study on Safety and Pharmacokinetics of Intravenous F901318 for Fungal Prophylaxis in AML Patients F901318, Caspofungin - Pulmonary Aspergillosis - Invasive, Acute Myeloid Leukemia | Phase 1 / Phase 2 | Withdrawn | F2G Ltd | 2017-04-20 | 2018-02-15 | |
| Safety and Pharmacokinetics of Oral F901318 (Fluconazole and Posaconazole) IN Aml Leukaemia F901318 with fluconazole low dose, F901318 with fluconazole high dose, F901318 with posaconazole - Acute Myeloid Leukemia | Phase 1 / Phase 2 | Withdrawn | F2G Ltd | 2017-03-01 | 2018-02-15 | |
| Study of Potential for Interaction of Fluconazole With F901318 F901318, Fluconazole - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 20 | 2016-02-01 | 2017-02-02 |
| Evaluation of the Potential for Cytochrome P450 3A4 Inhibition by F901318 Using Oral Midazolam as a Probe Midazolam with F901318 - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 20 | 2016-01-01 | 2016-06-09 |
| F901318 Multiple Ascending Dose Study F901318, Placebo - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 72 | 2015-02-01 | 2016-09-19 |
| F901318 Single Ascending Dose Study in Healthy Male Volunteers F901318, Placebo - Invasive Aspergillosis | Phase 1 | Completed | F2G Ltd | 40 | 2014-08-01 | 2015-09-07 |
Invasive Fungal Infections (4) · Coccidioidomycosis (3) · Leukemia, Myeloid, Acute (2) · Coccidioidal Meningitis (1) · Invasive Pulmonary Aspergillosis (1) · Mycoses (1) · Renal Insufficiency (1)
F2G Ltd (15) · F2G Biotech GmbH (3) · Fariba Donovan (1)
United Kingdom (10) · United States (5) · Netherlands (3) · Australia (2) · Belgium (2) · Brazil (2) · France (2) · Germany (2) · Israel (2) · South Korea (2) · Spain (2) · Thailand (2) · Turkey (Türkiye) (2) · Vietnam (2) · Canada (1)
A Stewart (1) · Adeep Puri (1) · David Bell, MD (1) · Fariba Donovan, MD, PhD (1) · Frans van den Berg, MB ChB (1) · George R. Thompson, MD (1) · Jan Jaap van Lier, MD (1) · Jim Bush, MB ChB PhD MRCS FFPM (1) · Jim Bush, MBChB (1) · Johan Maertens, MD (1) · Litza McKenzie, MD (1) · Oliver A Cornely, MD (1) · Oliver Cornely, PhD, MD (1) · Salvatore Febbraro, MD (1)
PMID 42008658, PMID 40541222, PMID 41914555, PMID 42446237, PMID 42475691
2014 (1)