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New hope against deadly fungus: phase 3 trial launched

NCT ID NCT05101187

Disease control Sponsor: F2G Biotech GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called olorofim against a standard treatment (AmBisome followed by usual care) for a serious lung infection caused by Aspergillus fungus. About 225 adults with proven or probable infection will take part. The main goal is to see if olorofim reduces deaths by day 42.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 225 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female patients ages over 18 years and weighing more than 30 kg 2. Patients with proven IA at any site or probable LRTD IA per EORTC/MSG 2019 criteria as adapted for this study and where the duration of specific therapy for this episode of IA has been ≤ 28 days. For purposes of this inclusion, the duration of specific therapy includes any mould-active therapy given for this episode of IA whether subsequently judged potentially effective or not. 3. Patients requiring therapy with an antifungal agent other than a mould-active azole, and who have had ≤ 96 hours of potentially effective prior therapy. Potentially effective prior therapy includes any agent to which the infecting strain of Aspergillus is likely to be susceptible. There are no exclusions or limitations on such agents (eg, AmBisome® is permitted) other than their duration. 4. AmBisome® is an appropriate therapy for the patient. Exclusion Criteria: 1. Women who are pregnant or breastfeeding. 2. Known history of allergy, hypersensitivity, or any serious reaction to any component of the study drug 3. Patients with only chronic aspergillosis, aspergilloma, or allergic bronchopulmonary aspergillosis. 4. Suspected mucormycosis (zygomycosis). 5. Patients with a known active second fungal infection of any type, other than candidiasis that can be treated with fluconazole. 6. The requirement for ongoing use of echinocandin as Candida prophylaxis. 7. Microbiological findings (eg, bacteriological, virological) or other potential conditions that are temporally related and suggest a different aetiology for the clinical features. 8. Human immunodeficiency virus (HIV) infection but not currently receiving antiretroviral therapy. 9. Patients with a baseline prolongation of QT using Fridericia's Correction Formula (QTcF) ≥ 500 msec, or at high risk for QT/QTc prolongation. 10. Evidence of hepatic dysfunction.

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Conditions

The condition(s) this trial relates to.

invasive aspergillosis Invasive Fungal Infections

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Invasive aspergillosis

Contacts and locations

Locations

  • AOU Policlinico di Modena

    Modena, 41124, Italy

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • AZ Sint-Jan

    Bruges, 8000, Belgium

  • Acibadem Atakent Hospital

    Istanbul, 34303, Turkey (Türkiye)

  • Anhui Provincial Hospital

    Hefei, 230001, China

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • Augusta University

    Augusta, Georgia, 30912, United States

  • Azienda Ospedaliera Universitaria Luigi Vanvitelli

    Naples, Campania, 80138, Italy

  • Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)

    Pisa, 56100, Italy

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Doubs, 25030, France

  • CHU Bordeaux Hopital Saint André

    Bordeaux, Gironde, 33000, France

  • CHU de Besancon

    Besançon, Doubs, 25030, France

  • CHU de Nantes CIC Hematologie

    Nantes, Loire Atlantique, 44093, France

  • CHU de Rennes - Hôpital Pontchaillou

    Rennes, Ille-et-Vilaine, 35000, France

  • Chaim Sheba Medical Center

    Ramat Gan, 5265601, Israel

  • Charite Universitatsmedizin Berlin

    Berlin, 12203, Germany

  • Chenzhou No.1 People's Hospital

    Chenzhou, 423000, China

  • Chiba University Hospital

    Chiba, Chiba, 260 8677, Japan

  • China Medical University Hospital

    Taichung, 404, Taiwan

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Clairvoyant Research Group, LLC

    Las Vegas, Nevada, 89119, United States

  • Clinica Malattie Infettive Dipartimento di Medicina e Chirurgia dell'Università

    Perugia, 6129, Italy

  • Dicle University, Medical Faculty

    Diyarbakır, 21280, Turkey (Türkiye)

  • Duke Department of Medicine Infectious Diseases Division

    Durham, North Carolina, 27710, United States

  • Ege University Medical Faculty

    Izmir, 35100, Turkey (Türkiye)

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Di Monza E Della Brianza, 20900, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, 168, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109-1024, United States

  • Fujian Medical University Union Hospital

    Fuzhou, 350001, China

  • Guangdong Provincial People's Hospital

    Guangzhou, 510080, China

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Hadassah University Hospital - Ein Kerem

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences - Juravinski Site

    Hamilton, Ontario, L8L 2X2, Canada

  • Henan Provincial People's Hospital

    Zhengzhou, 450003, China

  • Hospital Claude Huriez

    Lille, Nord, 59037, France

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer

    Curitiba, Paraná, 81520-060, Brazil

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais, 30110-934, Brazil

  • Hospital General Universitario Gregorio Marañón

    Retiro, Madrid, 28007, Spain

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034, Spain

  • Hospital da Universidade Federal de Santa Maria CEP/UFSM

    Santa Maria, Rio Grande do Sul, 97105-900, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Houston Methodist

    Houston, Texas, 77030, United States

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200040, China

  • Huazhong University of Science and Technology

    Wuhan, Hubei, 430022, China

  • Hôpital Erasme

    Brussels, 1070, Belgium

  • Hôpital Necker - Enfants Malades

    Paris, Paris, 75015, France

  • IRCCS Ospedale Policlinico San Martino

    Genova, 16132, Italy

  • Imperial College London

    London, W6 8RP, United Kingdom

  • Inmi Lazzaro Spallanzani Irccs

    Roma, 149, Italy

  • Institut Universitaire du Cancer de Toulouse- IUCT-O

    Toulouse, Haute Garonne, 31059, France

  • Institut de Cancérologie de Strasbourg Europe - ICANS

    Strasbourg, Bas Rhin, 67200, France

  • Institute of Hematology and Blood Diseases Hospital

    Xiaobailou, Tianjin Municipality, 300020, China

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

  • Istituto Clinico Humanitas

    Rozzano, Milano, 2089, Italy

  • Jichi Medical University Hospital

    Shimotsuke, 3290431, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589 8511, Japan

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Kyushu University Hospital

    Fukuoka, Fukuoka, 812 8582, Japan

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • NIH Clinical Center ,NIAID,NIH

    Bethesda, Maryland, 20892, United States

  • Nagasaki University Hospital

    Nagasaki, 852 8501, Japan

  • Nanfang Hospital of Southern Medical University

    Guangzhou, 510515, China

  • National Taiwan University Hospital

    Taipei, Taiwan

  • National University Hospital

    Singapore, 117599, Singapore

  • OU Health OU Medical Center

    Oklahoma City, Oklahoma, 73104, United States

  • Okayama University Hospital

    Okayama, 700 8558, Japan

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55270, Turkey (Türkiye)

  • Osaka International Cancer Institute

    Osaka, Osaka, 541 8567, Japan

  • Osaka Metropolitan University Hospital

    Osaka, Osaka, 545 8586, Japan

  • Ospedale San Raffaele

    Milan, 20132, Italy

  • Peking University People's Hospital

    Beijing, 100033, China

  • Peking University Third Hospital

    Beijing, 100191, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012, China

  • Radboud Nijmegen

    Nijmegen, 6525GA, Netherlands

  • Royal Brisbane & Women's Hospital

    Herston, Queensland, 4029, Australia

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050, Australia

  • Royal NorthShore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • Rutgers RWJMS

    New Brunswick, New Jersey, 08901, United States

  • Saitama Medical Center Jichi Medical University

    Saitama, 3290431, Japan

  • Samsung Medical Center

    Irwon-dong, Seoul, 06351, South Korea

  • Santa Casa de Misericórdia de Belo Horizonte

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Santa Casa de Misericórdia de Passos

    Passos, Minas Gerais, 37904-020, Brazil

  • Shengjing Hospital of China Medical University

    Shengyang, 110055, China

  • Singapore General Hospital- Parent

    Singapore, 169608, Singapore

  • Siriraj Hospital

    Bangkok Noi, Bangkok, 10700, Thailand

  • Soroka University Medical Center

    Beersheba, 84001, Israel

  • Srinagarind Hospital

    Khon Kaen, 40002, Thailand

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, 23561, Taiwan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • Tel Aviv Sourasky Medical Center Pt

    Tel Aviv, 64239, Israel

  • The 1st Affiliated Hosp of Wenzhou Medical University

    Wenzhou, Zhejiang, 325000, China

  • The Alfred Hospital

    Melbourne, Victoria, 3181, Australia

  • The Catholic University of Korea

    Bucheon-si, Seoul, 06591, South Korea

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004, China

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, 510080, China

  • The First Affiliated Hospital of Zhejiang University school of medicine

    Hangzhou, 310003, China

  • The First Hospital of Jilin University

    Changchun, 130021, China

  • The Jikei University Hospital

    Minato-Ku, Tokyo, 105-8471, Japan

  • The Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530000, China

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, 50004, China

  • Tohoku University Hospital

    Sendai, Miyagi, 980 8574, Japan

  • Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

    Bunkyō City, 1138677, Japan

  • Toranomon Hospital

    Minatoku, Tokyo to, 105 8470, Japan

  • Toronto General Hospital

    Toronto, Ontario, M5G1M1, Canada

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California, 94143, United States

  • UKE Universitaetsklinikum-Hamburg Eppendorf

    Hamburg-Eppendorf, 30625, Germany

  • UMC Utrecht

    Utrecht, 3508 GA, Netherlands

  • UZ Leuven

    Leuven, 3000, Belgium

  • Universitaetsklinikum Koeln

    Cologne, 59037, Germany

  • Universitair Ziekenhuis Gent

    Ghent, 3000, Belgium

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 4103, Germany

  • University Health Network

    Toronto, Ontario, M5G1N8, Canada

  • University Hospital of Wales

    Cardiff, Wales, CF14 4XW, United Kingdom

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35249, United States

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7, Canada

  • University of California Davis Health System

    Sacramento, California, 95817, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Florida

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    Kansas City, Kansas, 64111, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota

    Minneapolis, Minnesota, 55455, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • University of Pittsburgh Medical Center Health System

    Pittsburgh, Pennsylvania, 15232, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medicine NY Presbyterian Hospital

    New York, New York, 10065, United States

  • Wellington Regional Hospital

    Newtown, Wellington Region, 6021, New Zealand

  • Xi'an International Medical Center

    Xi'an, 710126, China

  • Xiangya Hospital, Central South University

    Changsha, 410000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.