Drugs / Olorofim
Olorofim
English name olorofim
Trials 20
| 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| Phase 1 | NCT02912026 | May → Jul 2019 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |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| Phase 1 | NCT03095547 | May → Jul 2017 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1 | NCT03076905 | May → Jul 2017 | invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |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| Phase 1/2 | NCT02856178 | Apr 2017 | acute myeloid leukemia, invasive aspergillosis | F2G Ltd | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT03036046 | Mar → Sep 2017 | acute myeloid leukemia | F2G Ltd | Withdrawn | No outcome recorded |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 |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07712484 Comparator | Dec 2026 → Jun 2028 expected | coccidioidomycosis | F2G Ltd | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05101187 Comparator | Apr 2022 → Nov 2025 | invasive aspergillosis | F2G Ltd | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2026-06-18 | Shionogi | Results F2G and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients with Invasive Aspergillosis shionogi.com ↗
The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome® followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). |
| 2026-06-18 | F2G Ltd | Results F2G and Shionogi Announce Positive Topline Results from Global Phase 3 OASIS Study Evaluating Oral Olorofim Versus AmBisome® Followed by Standard of Care in Patients with Invasive Aspergillosis f2g.com ↗
The study met its primary endpoint of non-inferiority, with a rate of all-cause mortality (ACM) at Day 42 for olorofim of 23.8% vs. 24.3% for AmBisome® followed by SOC (difference of -0.5% with 95% confidence interval of -13.1 to 10.8%). |
| 2025-06-18 | F2G Ltd | Results F2G Announces Publication in The Lancet Infectious Diseases of Phase 2b Data Demonstrating Positive Therapeutic Responses in Patients with Serious Invasive Fungal Diseases Treated with Oral Olorofim f2g.com ↗
The results, now published in The Lancet Infectious Diseases (“The Lancet ID”), highlight olorofim’s encouraging therapeutic responses across a broad range of difficult-to-treat fungal pathogens and expands on data presented at the Trends in Medical Mycology (TIMM) meeting in October 2023. |
| 2023-06-19 | F2G Ltd | Regulatory F2G Receives Complete Response Letter from FDA for New Drug Application for Olorofim for The Treatment of Invasive Fungal Infections; Plans Resubmission With Additional Data and Analyses f2g.com ↗
According to the CRL, FDA was not able to approve olorofim at this time, requesting additional data and analyses. |
| 2022-12-19 | F2G Ltd | Regulatory F2G Announces FDA Filing Acceptance of New Drug Application for Olorofim for the Treatment of Invasive Fungal Infections f2g.com ↗
F2G Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for olorofim for the treatment of invasive fungal infections in patients who have limited or no treatment options. |
| 2022-10-21 | F2G Ltd | Results F2G Announces Data from Phase 2b Study at ID Week 2022 Showing Positive Therapeutic Response in Patients with Invasive Fungal Infections Treated with Olorofim f2g.com ↗
Overall, a 44% response rate, defined as complete or partial response, was seen across fungi at day 42, the primary endpoint |
| 2020-10-22 | F2G Ltd | Regulatory F2G Receives Second US FDA Breakthrough Therapy Designation for Olorofim f2g.com ↗ |
| 2020-06-10 | F2G Ltd | Regulatory F2G’s olorofim receives both FDA Orphan Drug Designation for Coccidioidomycosis (Valley Fever) and FDA QIDP designation for multiple fungal infections f2g.com ↗
F2G Ltd, a UK- and Austria-based biotech developing novel therapies for life-threatening systemic fungal infections, announced today that following the granting of Breakthrough Therapy designation in November (the first antifungal ever to achieve such a designation), the U.S. Food and Drug Administration (FDA) has also granted Qualified Infectious Disease Product (QIDP) designation to its lead first-in-class candidate, olorofim (formerly F901318) for the following requested indications: |
| 2020-03-09 | F2G Ltd | Regulatory F2G Receives US FDA Orphan Drug Designation for Olorofim f2g.com ↗
the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to its lead first-in-class candidate, olorofim |
| 2019-11-11 | F2G Ltd | Regulatory F2G Receives US FDA Breakthrough Therapy Designation for Olorofim f2g.com ↗
Olorofim is the first antifungal agent to be granted Breakthrough Therapy designation. |
| 2017-01-09 | F2G Ltd | Regulatory F2G Ltd Receives European Orphan Drug Designation for its Lead Candidate F901318 f2g.com ↗
the European Medicines Agency (EMA) Committee for Orphan Medicinal Products has granted orphan drug status to its lead clinical candidate, F901318, for the treatment of invasive Aspergillosis and rare mould infections caused by Scedosporium species. |
| 2016-10-26 | F2G Ltd | Results F2G Ltd announces publication of initial F901318 data in scientific journal PNAS f2g.com ↗ |
All press releases naming this drug 17 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 25 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 NCT02808741 ↗ |
| 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 ↗ |