Evidence map›Paper›PMID 41914555›Full record

Trial reportThe Journal of antimicrobial chemotherapy2026

Olorofim in combination with azole antifungals: results from the Phase 2 salvage therapy study.

Johan Maertens, Sharon C A Chen, George R Thompson, Fariba Donovan, Aaron Dane, Mike Birch, Corinne Pinder, Jill Bennett, Valerie Ravenna, Omar Marin Fernandez and 4 more

Registry-linked trialAbstract readClinical Trial, Phase II
In one paragraph

Trial report in The Journal of antimicrobial chemotherapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03583164 (Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03583164 phase2completednot on this map

Phase IIb Study of F901318 as Treatment of Invasive Fungal Infections Due to Lomentospora Prolificans, Scedosporium Spp., Aspergillus Spp., and Other Resistant Fungi in Patients Lacking Suitable Alternative Treatment Options

TypeinterventionalSponsorF2G Biotech GmbHRan2018 to 2023Enrolled203ConditionsInvasive Fungal InfectionsArmsOlorofim
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

14 authors.

Johan MaertensDepartment of Microbiology, Immunology, and Transplantation, KU Leuven, Leuven, Belgium.
Sharon C A ChenCentre for Infectious Diseases and Microbiology Laboratory Services, Institute for Clinical Pathology and Medical Research, New South Wales Health Pathology, Sydney, Australia.ORCID 0000-0002-9983-6603
George R ThompsonDivision of Infectious Diseases, Department of Internal Medicine, University of California Davis Medical Center, Sacramento, CA, USA.
Fariba DonovanValley Fever Center for Excellence, Division of Infectious Diseases, Department of Medicine, University of Arizona, Tucson, AZ, USA.ORCID 0000-0002-6203-5693
Aaron DaneDaneStat Consulting, Macclesfield, UK.
Mike BirchF2G Ltd., Nether Alderley, Macclesfield, UK.
Corinne PinderF2G Ltd., Nether Alderley, Macclesfield, UK.ORCID 0000-0002-7294-3054
Jill BennettF2G Ltd., Nether Alderley, Macclesfield, UK.
Valerie RavennaF2G Ltd., Nether Alderley, Macclesfield, UK.
Omar Marin FernandezF2G Ltd., Nether Alderley, Macclesfield, UK.
Geoff RossF2G Ltd., Nether Alderley, Macclesfield, UK.
Daniela ZinziF2G Ltd., Nether Alderley, Macclesfield, UK.
John H RexF2G Ltd., Nether Alderley, Macclesfield, UK.
Phase 2b Olorofim Salvage Therapy Study Group

Funding

F2G
6 · The paper itself

Abstract

backgroundOlorofim is an antifungal agent with a novel mechanism of action against Aspergillus spp., rare moulds and dimorphic fungi. Preclinical studies reported unidirectional antagonism between olorofim and mould-active azoles (e.g. azoles other than fluconazole) against Aspergillus fumigatus in which the azole reduces the antifungal effect of olorofim.

methodsTo assess the potential clinical impact of this preclinical finding, we compared outcomes of olorofim with and without concomitant azoles from a Phase 2b salvage study in patients with invasive fungal diseases with few or no treatment options.

resultsAnalyses are limited by the study size but outcomes were similar for olorofim with and without an azole in combination (whether mould-active or not) at Days 42 (the primary study endpoint) and 84 for both Mycoses Study Group-European Organization for Research and Treatment of Cancer (MSG-EORTC) responses and for all-cause mortality in patients with aspergillosis (77 not receiving an azole, 24 receiving an azole in combination), in patients with coccidioidomycosis (11 not receiving an azole, 30 receiving an azole in combination) and in patients with other fungal infections (50 not receiving an azole, 10 receiving an azole in combination). In addition, the rate of drug-induced liver injury was not increased in patients receiving combination with an azole.

conclusionsAlthough limited by small numbers of patients for individual fungi, this analysis did not demonstrate a pattern of reduced clinical efficacy or tolerability of olorofim when given in combination with either the mould-active azoles or with fluconazole.Trial registration number. NCT03583164.

Indexed as

Antifungal AgentsAzolesHeterocyclic CompoundsInvasive Fungal InfectionsPyrimidinesSalvage TherapyAcetamidesAspergillosisDrug Therapy, CombinationHumansPiperazinesPyrrolesTreatment OutcomeAcetamidesAntifungal AgentsAzolesHeterocyclic CompoundsolorofimPiperazinesPyrimidinesPyrroles

Identifiers

PMID41914555
PMCPMC13036598

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.