Olorofim Clinical Trials (2026): 8 Studies for Healthy & Invasive Fungal Infections

Hipa.ai Research · Source: ClinicalTrials.gov / AACT

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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. Most recent activity: NCT07385638 (Jun 2027).

Olorofim clinical trials at a glance: phase × recruitment status

Phaseactive not recruitingcompletednot yet recruitingTotal
P155
P2112
P311

Recruiting Olorofim clinical trials (1)

Studies currently enrolling participants. Click any NCT ID to view the trial detail page (eligibility, sites, contacts).

NCT IDTitlePhaseIndicationEnrollmentStarted
NCT07385638Olorofim in Early Coccidioidal MeningitisP2Coccidioidal Meningitis12Mar 2026

Olorofim clinical trials by indication

Healthy (2)

NCTAcronymPhaseStatusTitle
NCT04207957P1completedA Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of Olorofim
NCT04171739DDIP1completedDrug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon Olorofim

Invasive Fungal Infections (2)

NCTAcronymPhaseStatusTitle
NCT03583164FORMULA-OLSP2completedEvaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment Options
NCT04039880hAMEP1completedAbsorption, Metabolism and Excretion of 14C-olorofim in Man

Coccidioidal Meningitis (1)

NCTAcronymPhaseStatusTitle
NCT07385638P2not yet recruitingOlorofim in Early Coccidioidal Meningitis

Invasive Aspergillosis (1)

NCTAcronymPhaseStatusTitle
NCT05101187OASISP3active not recruitingOlorofim Aspergillus Infection Study

Renal Impairment (1)

NCTAcronymPhaseStatusTitle
NCT05200286P1completedA Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal Impairment

Hepatic Impairment (1)

NCTAcronymPhaseStatusTitle
NCT04752540P1completedA 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.

AcronymNCTPhaseStatusIndicationEnrollmentPubMed
OASISNCT05101187P3active not recruitingInvasive Aspergillosis225
FORMULA-OLSNCT03583164P2completedInvasive Fungal Infections203PMID 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 IDAcronymTitlePhaseStatusEnrollmentSponsorStarted
NCT07385638Olorofim in Early Coccidioidal MeningitisP2not yet recruiting12Fariba DonovanMar 2026
NCT05101187OASISOlorofim Aspergillus Infection StudyP3active not recruiting225F2G Biotech GmbHMar 2022
NCT03583164FORMULA-OLSEvaluate F901318 (Olorofim) Treatment of Invasive Fungal Infections in Participants Lacking Treatment OptionsP2completed203F2G Biotech GmbHJun 2018
NCT05200286A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Renal ImpairmentP1completed16F2G Biotech GmbHFeb 2022
NCT04752540A Phase I Study to Assess the Pharmacokinetics of Olorofim in Subjects With Hepatic ImpairmentP1completed32F2G Biotech GmbHJul 2021
NCT04207957A Biopharmaceutics Study to Assess the Pharmacokinetics of Single Oral and IV Doses of OlorofimP1completed24F2G LtdDec 2019
NCT04171739DDIDrug-drug Interaction (DDI) Study to Assess Effect of Itraconazole and Rifampicin Upon OlorofimP1completed24F2G LtdNov 2019
NCT04039880hAMEAbsorption, Metabolism and Excretion of 14C-olorofim in ManP1completed12F2G LtdJul 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. 6 are marked completed.
Are Olorofim clinical trials recruiting in 2026?
No active Olorofim trials are recruiting on ClinicalTrials.gov as of the current AACT refresh. Trials may resume; this page is updated daily.
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.

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