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New pill could fight dangerous fungal infections

NCT ID NCT05178862

Disease control Sponsor: Scynexis, Inc. 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study tested a new oral antifungal drug, ibrexafungerp, for treating serious Candida infections in the blood or internal organs. 68 adults received an IV antifungal followed by either ibrexafungerp or standard oral fluconazole. The trial was stopped early, so the results are not conclusive.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ibrexafungerp (oral antifungal)
What this could lead to
If successful, this could offer a new oral option for treating serious fungal infections, potentially reducing hospital stays.
What could go wrong
The trial was terminated early with only 68 participants, so results are limited. It is unclear if ibrexafungerp is better than existing treatments.

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

68 people

The number who actually took part.

Started

Aug 2022

Finished

Dec 2025

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.

Key Inclusion Criteria: * Subject is a male or female adult ≥ 18 years of age on the day the study informed consent is signed. * Subject has a diagnosis of candidemia and/or invasive candidiasis, defined as evidence of Candida spp in either a bloodstream or tissue culture from a normally sterile site (excluding eye, cardiac tissue, bone tissue, central nervous system or prosthetic device) collected ≤ 4 days (within 96 hours) prior to initiation of IV echinocandin accompanied by any related clinical signs and/or symptoms (e.g., fever \[on one occasion \> 38°C\], hypotension, or local signs of inflammation). Key Exclusion Criteria: * Subject has any of the following forms of invasive candidiasis at Screening: * Septic arthritis in a prosthetic joint (septic arthritis in a native joint is allowed), * Osteomyelitis, * Endocarditis or myocarditis, * Meningitis, endophthalmitis, or any central nervous system infection, * Chronic disseminated candidiasis, * Urinary tract candidiasis due to ascending Candida infection secondary to unresolved obstruction or non-removeable device in the urinary tract, * Patients with a sole diagnosis of mucocutaneous candidiasis, i.e., oropharyngeal, esophageal, or genital candidiasis; or Candida lower urinary tract infection or Candida isolated solely from respiratory tract specimens, * Patients with concurrent invasive fungal infection other than Candida spp., e.g., cryptococcosis, mold infection or endemic fungal infection, * Patients who failed a previous antifungal therapy for the same infection, * Subject has an inappropriately controlled fungal disease source (e.g., indwelling vascular catheter or device that cannot be removed or an abscess that cannot be drained) that is likely to be the source of the candidemia or invasive candidiasis. * Subject has abnormal liver test parameters: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 10-fold the upper limit of normal (ULN). * Subject has severe hepatic impairment and a history of chronic cirrhosis (Child-Pugh score \> 9). * Subject has received more than 48 hours of non-echinocandin antifungal therapy for the treatment of invasive candidiasis (including candidemia) within 96 hours preceding initiation of IV echinocandin. o Exception: Receipt of antifungal therapy to which any Candida spp. isolated in qualifying culture is not susceptible. * Baseline QTcF ≥ 500 msec.

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Conditions

The condition(s) this trial relates to.

candidemia candidiasis, invasive disseminated candidiasis

As listed by the trial registrant

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

Candidemia Candidiasis, invasive

Contacts and locations

Locations

  • Augusta University Medical Center

    Augusta, Georgia, 30912, United States

  • Banner University Medical Center-Tucson

    Tucson, Arizona, 85719, United States

  • Big Metropolitan Hospital Niguarda Regional Health Authority

    Milan, 20162, Italy

  • CHA Bundang Medical Center, CHA University

    Gyeonggi-do, South Korea

  • Central Friuli University Healthcare Company

    Udine, Italy

  • Chaim Sheba Medical Center

    Tel Litwinsky, Israel

  • Chinese Academy of Medical Sciences

    Jinghai, Tianjin Municipality, 301617, China

  • Duke University

    Durham, North Carolina, 27710, United States

  • FCRN Clinical Trials Centre

    Vereeniging, Gauteng, 1935, South Africa

  • Frankfurt University Clinic

    Frankfurt, 60596, Germany

  • Fred Hutchinson Cancer Research Center

    Seattle, Washington, 98109, United States

  • Gangnam Severance Hospital

    Seoul, South Korea

  • General Hospital of Athens "Evangelismos"

    Athens, Greece

  • General Hospital of Athens "Evangelismos", 1st Department of Critical Care

    Athens, Greece

  • General Hospital of Thessaloniki "Ippokratio"

    Thessaloniki, Greece

  • General University Hospital Gregorio Maranon

    Madrid, Spain

  • Hainan General Hospital

    Haikou, Hainan, 572000, China

  • Helios Clinic Wuppertal

    Wuppertal, Germany

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Hospital Clínic de Barcelona

    Barcelona, Catalonia, 08036, Spain

  • Hospital del Mar Medical Research Institute (IMIM)

    Barcelona, Catalonia, Spain

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Huashan Hospital, Institute of Antibiotics

    Shanghai, Shanghai Municipality, 200040, China

  • IRCCS- University Hospital San Martino-IST

    Genoa, Liguria, 16132, Italy

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Keimyung University - Dongsan Medical Center

    Daegu, South Korea

  • LAIKO General Hospital

    Athens, Greece

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103, United States

  • Lady Davis Carmel Medical Center, Infectious Diseases Unit

    Haifa, Israel

  • Lakeview Hospital

    Benoni, Gauteng, 1500, South Africa

  • Life Groenkloof Hospital

    Pretoria, Gauteng, 0181, South Africa

  • Lishui People's Hospital

    Lishui, Zhejiang, 323000, China

  • Liuzhou People's Hospital

    Liuzhou, Liuzhou, 530021, China

  • Mayo Clinic - Rochester

    Rochester, Minnesota, 55905, United States

  • McGill University Health Centre

    Montreal, Quebec, H4A 3J1, Canada

  • Mediclinic Victoria

    Tongaat, KwaZulu-Natal, 4400, South Africa

  • Mercury Street Medical Group, PLLC

    Butte, Montana, 59701, United States

  • Municipal Hospital Munich GMbH/Hospital Neuperlach

    Munich, Germany

  • Nanfang Hospital of Southern Medical University

    Guangdong, Guangzhou, 510420, China

  • Nantes University Hospital Center

    Nantes, 44093, France

  • Netcare Jakaranda Hospital

    Pretoria, Gauteng, 0002, South Africa

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121, United States

  • Paris University Hospitals Center- Cochin Hospital

    Paris, France

  • Princess Margaret Hospital

    Toronto, Ontario, Canada

  • Qingyuan People's Hospital

    Qingyuan, Guangdong, 511518, China

  • Rambam Health Care Campus, Institute of Infectious Diseases

    Haifa, Israel

  • Rhode Island Hospital

    Providence, Rhode Island, 02903, United States

  • Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025, China

  • Saint Luc University Hospital

    Brussels, Belgium

  • Saint-Louis Hospital

    Paris, France

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shanghai 10th People's Hospital

    Shanghai, Shanghai Municipality, 200072, China

  • Sir Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine

    Hangzhou, Zhejiang, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Yuzhong, 400042, China

  • The First Affiliated Hospital of Guangzhou Medical University

    Guandong, Guangzhou, 510230, China

  • The First Affiliated Hospital of Jinan University

    Guandong, Guangzhou, 510630, China

  • The First Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510080, China

  • The First Hospital of Kunming

    Kunming, Yunnan, 650034, China

  • The Miriam Hospital

    Providence, Rhode Island, 02906, United States

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239, Israel

  • The Third Affiliated Hospital Of Sun Yat-Sen University (ZSSY)

    Guangdong, Guangzhou, 510630, China

  • The first affiliated hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003, China

  • Tianjin Medical University General Hospital

    Xiaobailou, Tianjin Municipality, 300052, China

  • UC Davis Medical Center

    Sacramento, California, 95817, United States

  • UCSF School of Medicine

    San Francisco, California, 94143, United States

  • Univeristy Hospital Jena

    Jena, Thuringia, Germany

  • University Clinical Hospital of Valencia

    Valencia, Spain

  • University General Hospital "Attikon"

    Athens, Greece

  • University Health Network- Toronto General Hospital

    Toronto, Ontario, Canada

  • University Hospital Center of Poitiers

    Poitiers, France

  • University Hospital Cologne

    Cologne, 50937, Germany

  • University Hospital Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, Germany

  • University Hospital Ghent

    Ghent, Belgium

  • University Hospital Puerta de Hierro Majadahonda

    Madrid, Spain

  • University Hospital Ramon y Cajal

    Madrid, 28034, Spain

  • University Hospital Virgen Macarena

    Seville, Andalusia, Spain

  • University Hospital de La Princesa

    Madrid, Spain

  • University Hospitals Leuven, Campus Gasthuisberg

    Leuven, Belgium

  • University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv", Plovdiv, Department of Surgery

    Plovdiv, Bulgaria

  • University Multiprofile Hospital for Active Treatment "Prof. Dr. Stoyan Kirkovich"

    Stara Zagora, Bulgaria

  • University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Clinic of Purulent-Septic Surgery

    Sofia, Bulgaria

  • University Polyclinic Hospital of Modena

    Modena, 41124, Italy

  • University and Polytechnic Hospital La Fe

    Valencia, Spain

  • University of Alabama at Birmingham School of Medicine

    Birmingham, Alabama, 70121, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Colorado Anschutz Medical Campus

    Denver, Colorado, 80291, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Michigan Hospital

    Ann Arbor, Michigan, 48109, United States

  • University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15260, United States

  • University of Pretoria and Steve Biko Academic Hospital

    Pretoria, South Africa

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Victor Dupouy Hospital Center Argenteuil

    Argenteuil, 95107, France

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041, China

  • Wonju Severance Christian Hospital

    Wŏnju, South Korea

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008, China

  • Zhejiang Provincal Hospital of Chinese Medicine

    Hangzhou, Zhejiang, 310006, China

  • Zuid-Afrikaans Hospital

    Pretoria, Gauteng, 0002, South Africa

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