Olorofim Clinical Trials (2026): 8 Studies for Healthy & Invasive Fungal Infections
Hipa.ai Research · Source: ClinicalTrials.gov / AACT
Synced daily from ClinicalTrials.gov via AACT. Last sync: .
8 Olorofim clinical trials are catalogued on Hipa.ai from the AACT mirror of ClinicalTrials.gov, spanning 6 indications (including Healthy & Invasive Fungal Infections) and 548 total planned enrollment. 1 Phase 3 Olorofim trial and 2 Phase 2 are listed. 1 Olorofim clinical trial is actively recruiting at 1 U.S. site across 1 state. Most recent activity: NCT07385638 (Jun 2027).
Where to Participate: All Olorofim Trial Sites in the U.S. (1 site across 1 state)
Every actively recruiting Olorofimtrial site, sorted by state then city. Each row links to the trial detail page (eligibility, contacts, full study record). Sites no longer enrolling at the location level are excluded. ClinicalTrials.gov / AACT does not provide street-level addresses; the map link uses the facility's geocoded coordinates where available.
| State | Facility | City | Trial | Map |
|---|---|---|---|---|
| AZ | Banner University Medical Center | Tucson85719 | NCT07385638 | Map |
Olorofim clinical trials at a glance: phase × recruitment status
| Phase | recruiting | active not recruiting | completed | Total |
|---|---|---|---|---|
| P1 | 5 | 5 | ||
| P2 | 1 | 1 | 2 | |
| P3 | 1 | 1 |
Recruiting Olorofim clinical trials (1)
Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).
| NCT ID | Title | Phase | Indication | Enrollment | Started |
|---|---|---|---|---|---|
| NCT07385638 | Olorofim in Early Coccidioidal Meningitis | P2 | Coccidioidal Meningitis | 12 | Jun 2026 |
Olorofim clinical trials by indication
Healthy (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04207957 | — | P1 | completed | A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim |
| NCT04171739 | DDI | P1 | completed | Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim |
Invasive Fungal Infections (2)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT03583164 | FORMULA-OLS | P2 | completed | Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options |
| NCT04039880 | hAME | P1 | completed | Absorption, Metabolism and Excretion of 14C-olorofim in Man |
Coccidioidal Meningitis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT07385638 | — | P2 | recruiting | Olorofim in Early Coccidioidal Meningitis |
Invasive Aspergillosis (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05101187 | OASIS | P3 | active not recruiting | Olorofim Aspergillus Infection Study |
Renal Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT05200286 | — | P1 | completed | A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment |
Hepatic Impairment (1)
| NCT | Acronym | Phase | Status | Title |
|---|---|---|---|---|
| NCT04752540 | — | P1 | completed | A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment |
Olorofim pivotal trial highlights (Phase 2/3/4)
Phase-2/3/4 studies with named acronyms — the registration-grade trials most cited in label discussions and Wikipedia.
| Acronym | NCT | Phase | Status | Indication | Enrollment | PubMed |
|---|---|---|---|---|---|---|
| OASIS | NCT05101187 | P3 | active not recruiting | Invasive Aspergillosis | 225 | — |
| FORMULA-OLS | NCT03583164 | P2 | completed | Invasive Fungal Infections | 203 | PMID 40541222 |
All Olorofim trials (8)
Sorted by most recent activity (completion → start → posted date). Each row links to the trial detail page on Hipa.ai.
| NCT ID | Acronym | Title | Phase | Status | Enrollment | Sponsor | Started |
|---|---|---|---|---|---|---|---|
| NCT07385638 | Olorofim in Early Coccidioidal Meningitis | P2 | recruiting | 12 | Fariba Donovan | Jun 2026 | |
| NCT05101187 | OASIS | Olorofim Aspergillus Infection Study | P3 | active not recruiting | 225 | F2G Biotech GmbH | Mar 2022 |
| NCT03583164 | FORMULA-OLS | Evaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options | P2 | completed | 203 | F2G Biotech GmbH | Jun 2018 |
| NCT05200286 | A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment | P1 | completed | 16 | F2G Biotech GmbH | Feb 2022 | |
| NCT04752540 | A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic Impairment | P1 | completed | 32 | F2G Biotech GmbH | Jul 2021 | |
| NCT04207957 | A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim | P1 | completed | 24 | F2G Ltd | Dec 2019 | |
| NCT04171739 | DDI | Drug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim | P1 | completed | 24 | F2G Ltd | Nov 2019 |
| NCT04039880 | hAME | Absorption, Metabolism and Excretion of 14C-olorofim in Man | P1 | completed | 12 | F2G Ltd | Jul 2019 |
Olorofim clinical trials: frequently asked questions
- How many Olorofim clinical trials are there?
- 8 Olorofim clinical trials are catalogued on Hipa.ai, sourced from the AACT mirror of ClinicalTrials.gov. 1 is actively recruiting participants. 6 are marked completed.
- Are Olorofim clinical trials recruiting in 2026?
- Yes — 1 Olorofim trial is actively recruiting in 2026, with 1 U.S. site across 1 state. See the recruiting trials and the per-state site list further down this page.
- What conditions is Olorofim being studied for?
- Olorofim is being studied for Healthy, Invasive Fungal Infections, Coccidioidal Meningitis, Hepatic Impairment, Invasive Aspergillosis and 1 more. The trials are grouped by indication on this page.
- What phase is Olorofim in?
- Olorofim clinical trials span 1 Phase 3, 2 Phase 2, 5 Phase 1. The phase × status matrix at the top of this page breaks down counts by phase and recruitment status.
- Who sponsors Olorofim clinical trials?
- The lead sponsor across the most Olorofim trials is F2G Biotech GmbH, with 1 additional lead sponsor listed in the data. Each trial row links to the full study detail page including sponsor information.
Sources and methodology
Trial inventory derived from the AACT mirror of ClinicalTrials.gov. Trials are filtered to those naming Olorofimas an intervention. Phase, status, enrollment, sponsor, and dates are taken from the source `studies` table; primary indication is the first listed condition. Acronyms are extracted from each trial's brief title where present. PubMed links are populated for trials whose published primary outcomes have been indexed in our evidence cache.
Last refreshed .
Related pages on Hipa.ai: