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New hope for stubborn lung infection? trial of epetraborole begins, then stops

NCT ID NCT05327803

Disease control Sponsor: AN2 Therapeutics, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested an oral drug called epetraborole for people with a tough-to-treat lung infection called MAC lung disease. The trial aimed to see if adding epetraborole to standard treatment could improve symptoms and clear the infection. However, the study was terminated early, so we have less information than hoped.

What this could mean

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

Active substance
epetraborole
What this could lead to
If successful, this could provide a new oral treatment option for people with hard-to-treat MAC lung disease.
What could go wrong
The trial was terminated early, so results are limited. It is unclear if epetraborole is effective or safe in this setting.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

177 people

The number who actually took part.

Started

May 2022

Finished

Dec 2024

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 or female patients who are 18 years of age or older. 2. Willing and able to provide written informed consent. 3. Patients with a diagnosis of treatment-refractory MAC lung disease consisting of all of the following (a) Microbiological, (b) Clinical, and (c) Radiographic criteria: 1. Microbiological criteria: * One Pre-Study MAC-positive respiratory specimen. Documentation of a MAC positive specimen collected per standard of care within 6 months prior to signing the informed consent form (ICF). * One Screening MAC-positive expectorated or induced sputum sample. 2. Clinical criteria: At least 2 of the following patient-reported clinical symptoms: * Cough with sputum production * Cough without sputum * Chest congestion * Hemoptysis * Dyspnea * Fatigue * Night sweats or unusual sweating 3. Radiographic criteria: Non contrast Chest CT scan within 6 months prior to signing the ICF with abnormalities consistent with MAC lung disease. 4. OBR criteria: An OBR is a combination regimen that consists of ≥2 antimycobacterial agents. The patient-specific OBR must be administered for a minimum duration of 6 consecutive months that is either ongoing at the time of Screening or was stopped or paused no more than 12 months before screening. The OBR regimen administered during Screening must be continued after randomization. 4. Patients who are willing to comply with all the study activities and procedures throughout the duration of the study and comply with all planned study visits and study procedures from Screening through the LFU Visit. 5. All patients must agree to use an effective method of birth control. 6. Patients expected to survive with continued antimycobacterial therapy and appropriate supportive care from Screening through the LFU Visit, in the judgment of the Investigator. Exclusion Criteria: 1. Patients with a presence of any suspected or confirmed disease or condition at Screening or the time of randomization that, in the opinion of the Investigator, may confound the assessment of symptom-based clinical response. 2. Patients with active pulmonary malignancy or any malignancy that required or would require chemotherapy or radiation therapy within 1 year prior to randomization through the LFU Visit. 3. Patients with creatinine clearance (CrCl) of ≤30 mL/min, as estimated by the Cockcroft Gault formula, at Screening. 4. Patients with hemoglobin \<10.0 g/dL or \<6.2 mmol/L at Screening; donation of blood or plasma within 28 days prior to randomization; or symptomatic loss of blood or hemorrhage within 28 days prior to randomization. 5. Patients with severe hemoptysis within 28 days prior to randomization, defined as \>100 mL over any 24-hour period or severe or extremely severe hemoptysis. 6. Patients with severe hepatic impairment, as evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>3 × upper limit of normal (ULN) or total bilirubin \>2 × ULN, or clinical signs of cirrhosis or end-stage hepatic disease. 7. Patients who are pregnant or breastfeeding. 8. Patients with a mean QT interval corrected using Fridericia's formula (QTcF) \>480 msec based on triplicate 12-lead ECGs at Screening. 9. Patients with an immunodeficiency or an immunocompromised condition and risk for an opportunistic pulmonary infection. 10. Patients with an anticipated start of new non-study antimycobacterial therapy to be administered at any time between Screening and Month 6. 11. Patients who have received any investigational medication during the 30 days or 5 half-lives, whichever is longer, prior to randomization. 12. Patients with any prior exposure to epetraborole. 13. Patients with any condition that, in the opinion of the Investigator, interferes with the ability to safely complete the study or adhere to study requirements, including the patient's inability or unwillingness to comply with all study assessments and visits.

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Conditions

The condition(s) this trial relates to.

Infections mycobacterial infectious disease Mycobacterium avium complex disease pulmonary non-tuberculous mycobacterial infection respiratory tract infectious disorder

As listed by the trial registrant

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

Mac lung disease Treatment refractory mac lung disease

Contacts and locations

Locations

  • 215001

    Tokyo, 160-8582, Japan

  • 215002

    Niigata, 951-8510, Japan

  • 215003

    Tokyo, 204-8522, Japan

  • 215004

    Fukuoka, 811-3195, Japan

  • 215005

    Tokyo, 162-8655, Japan

  • 215006

    Gifu, 502-8558, Japan

  • 215007

    Yamaguchi, Japan

  • 215008

    Osaka, 591-8555, Japan

  • 215009

    Kyoto, 610-0113, Japan

  • 215010

    Wakayama, 646-8558, Japan

  • 215011

    Yokohama, 245-8575, Japan

  • 215012

    Osaka, 591-8555, Japan

  • 215013

    Kyoto, 612-8555, Japan

  • 215014

    Hokkaido, 070-8644, Japan

  • 215016

    Fukuoka, 819-8555, Japan

  • 215017

    Kanagawa, 236-0051, Japan

  • 215018

    Ishikawa, 920-8530, Japan

  • 215019

    Aichi, 465-8620, Japan

  • 215020

    Ishikawa, 920-8650, Japan

  • 215021

    Kitakyushu, 806-0034, Japan

  • 215022

    Mie, 514-1101, Japan

  • 215023

    Nagano, 382-8577, Japan

  • 215024

    Tokyo, 180-8610, Japan

  • 215025

    Fukuoka, 814-0180, Japan

  • 215026

    Aomori, 036-8563, Japan

  • 215027

    Tokyo, Japan

  • 215028

    Ibaraki, 319-1113, Japan

  • 215029

    Osaka, 560-8552, Japan

  • 215030

    Hiroshima, 730-0822, Japan

  • 219001

    Seongnam-si, 13620, South Korea

  • 219002

    Seoul, 03080, South Korea

  • 219003

    Gwangju, 61469, South Korea

  • 219005

    Incheon, 21431, South Korea

  • 219007

    Seoul, 05505, South Korea

  • 219008

    Seoul, South Korea

  • 423001

    Charleston, South Carolina, 29425, United States

  • 423002

    Philadelphia, Pennsylvania, 19104, United States

  • 423003

    Baltimore, Maryland, 21231, United States

  • 423004

    Omaha, Nebraska, 68198, United States

  • 423005

    Tyler, Texas, 75708, United States

  • 423006

    Stanford, California, 94305, United States

  • 423007

    Portland, Oregon, 97239, United States

  • 423008

    St Louis, Missouri, 63110, United States

  • 423009

    Lebanon, New Hampshire, 03756, United States

  • 423011

    Milwaukee, Wisconsin, 53226, United States

  • 423012

    Charlottesville, Virginia, 22908, United States

  • 423013

    New York, New York, 10029, United States

  • 423014

    New York, New York, 10017, United States

  • 423015

    Kansas City, Kansas, 66205, United States

  • 423017

    Durham, North Carolina, 27705, United States

  • 423018

    DeLand, Florida, 32720, United States

  • 423024

    Manhasset, New York, 11030, United States

  • 423027

    Atlanta, Georgia, 30342, United States

  • 423029

    Iowa City, Iowa, 52242, United States

  • 423031

    Rochester, Minnesota, 55902, United States

  • 423032

    Birmingham, Alabama, 35233, United States

  • 423033

    Tampa, Florida, 33606, United States

  • 423034

    Kissimmee, Florida, 34746, United States

  • 423037

    Tucson, Arizona, 85724, United States

  • 423038

    Vero Beach, Florida, 32960, United States

  • 423039

    Winston-Salem, North Carolina, 27103, United States

  • 423042

    New Orleans, Louisiana, 70112, United States

  • 423045

    Charleston, South Carolina, 29414, United States

  • 423047

    Tampa, Florida, 33614, United States

  • 423054

    Tampa, Florida, 33612, United States

  • 423058

    Philadelphia, Pennsylvania, 19107, United States

  • 423060

    Baltimore, Maryland, 21201, United States

  • 423061

    Boston, Massachusetts, 02115, United States

  • 423063

    Wichita, Kansas, 67211, United States

  • 423065

    Jefferson, Louisiana, 70121, United States

  • 423067

    Nashville, Tennessee, 37232, United States

  • 423068

    Washington D.C., District of Columbia, 20037, United States

  • 423069

    San Francisco, California, 94143, United States

  • 423070

    Sacramento, California, 95817, United States

  • 423071

    Chapel Hill, North Carolina, 27599, United States

  • 423072

    Charlotte, North Carolina, 28204, United States

  • 423074

    Boston, Massachusetts, 02114-2696, United States

  • 423075

    Bay Pines, Florida, 33744, United States

  • 423076

    Indianapolis, Indiana, 46202, United States

  • 423078

    Ann Arbor, Michigan, 48109, United States

  • 423079

    Cleveland, Ohio, 44195, United States

  • 423080

    Edmonds, Washington, 98026, United States

  • 423081

    Fort Worth, Texas, 76104, United States

  • 423082

    Oklahoma City, Oklahoma, 73104, United States

  • 501001

    Greenslopes, Queensland, Australia

  • 501002

    South Brisbane, 4101, Australia

  • 501003

    Chermside West, Queensland, 4032, Australia

  • 501004

    Clayton, 3168, Australia

  • 501005

    Concord, New South Wales, 2139, Australia

  • 501007

    Birtinya, Queensland, 4575, Australia

  • 501008

    Perth, Western Australia, 6000, Australia

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