Drugs / Olorofim
Trials 20 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 116 trials | ||||||
| Phase 1 | NCT05200286 | Feb → Dec 2022 | impaired renal function disease | F2G Biotech GmbH | Completed | No outcome recorded |
| Phase 1 | NCT04752540 | Jul → Oct 2021 | — | F2G Biotech GmbH | Completed | No outcome recorded |
| Phase 1 | NCT04207957 | Dec 2019 → Sep 2020 | — | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04171739 | Nov 2019 → Feb 2020 | — | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT04039880 | Jul → Sep 2019 | fungal infectious disease | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02912026 | May → Jul 2019 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT03340597 | Dec 2017 → Apr 2018 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT03076905 | May → Jul 2017 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT03095547 | May → Jul 2017 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT02808741 | Jul → Nov 2016 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02737371 | May 2016 → May 2017 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02730442 | Feb → Jun 2016 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02680808 | Jan → Jun 2016 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02394483 | Oct 2015 → Sep 2016 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02342574 | Feb 2015 → Sep 2016 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1 | NCT02142153 | Aug → Oct 2014 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT02856178 | Apr 2017 | acute myeloid leukemia, invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03036046 | Mar → Sep 2017 | acute myeloid leukemia | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07385638 | Mar 2026 → Mar 2027 expected | meningitis | Fariba Donovan | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT03583164 | Jun 2018 → Feb 2023 | fungal infectious disease | F2G Biotech GmbH | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT07712484 Comparator | Dec 2026 → Jun 2028 expected | coccidioidomycosis | F2G Ltd | Not yet recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05101187 Comparator | Mar 2022 → Nov 2025 overdue | invasive aspergillosis | F2G Biotech GmbH | Active not recruiting | No outcome recorded |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 26 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | olorofim | “Olorofim is a novel oral antifungal agent which selectively inhibits the fungal enzyme dihydroorotate dehydrogenase found in molds including Aspergillus” PMID 42008658 ↗ Apr 2026 |
| Known as | F901318 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03095547 ↗ |
| Known as | Olorofim (F901318) | “Olorofim (F901318)” NCT05101187 ↗ |
| Action | Inhibit | “Olorofim is a novel oral antifungal agent which selectively inhibits the fungal enzyme dihydroorotate dehydrogenase found in molds including Aspergillus” PMID 42008658 ↗ Apr 2026 |
| Modality | Other / unclassified | “Olorofim, the first orotomide antifungal agent to be developed, is active against fungi that are resistant to registered therapies.” PMID 40541222 ↗ Jun 2025 |
| Modality | Small molecule | — CHEMBL4297609 ↗ |
| Route | Intravenous | “Single intravenous infusion over 4 hours” NCT02142153 ↗ |
| Target | DHODH | “Olorofim, a first-in-class clinical antifungal targeting dihydroorotate dehydrogenase (DHODH), represents a promising therapeutic option for IA.” PMID 42446237 ↗ Jul 2026 |