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Malaria drug artesunate tested for lung scarring

NCT ID NCT05988463

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This early-stage trial tests whether artesunate, a drug used for malaria, is safe for people with idiopathic pulmonary fibrosis (IPF), a disease that scars the lungs and makes breathing hard. Fifteen adults with IPF will receive either artesunate capsules or a placebo for 12 weeks, with the dose increasing every 4 weeks. The main goal is to check for side effects and find a safe dose for future studies.

What this could mean

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

Active substance
artesunate
What this could lead to
If safe, this could point toward a new treatment option for IPF, a lung-scarring disease with few therapies.
What could go wrong
This is a very early, small phase 1 safety trial with only 15 people. It is not designed to prove effectiveness, and many early drugs fail to show benefit in larger studies.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

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

Started

Aug 2026

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 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 Each participant must meet the following criteria to be enrolled in this study: 1. Age 40 years or older. 2. Diagnosis of IPF based upon ATS/ERS/JRS/ALAT 2018 guidelines (56) 3. FVC percent of predicted ≥ 30%; historical FVC for entry in the study is permitted if within 3 months of screening. 4. Diffusing capacity of lung for carbon monoxide (DLco) (hemoglobin-adjusted) ≥ 25%; historical DLco for entry in the study is permitted if within 3 months of screening. 5. Participants receiving nintedanib, pirfenidone, and/or nerandomilast for the treatment of idiopathic pulmonary fibrosis (IPF), including combination therapy (e.g., nintedanib plus nerandomilast or pirfenidone plus nerandomilast), are eligible for enrollment. All background IPF therapies must be stable for at least 6 weeks prior to the Screening visit and taken continuously with no or only rare interruptions. 6. Female participants of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male participants with sexual partners of childbearing potential agree to use highly effective methods of birth control during their participation in the study and for 60 days after the last administration of study drug. Women of child-bearing potential are defined as any female who has experienced menarche and who is not permanently sterile or postmenopausal. Postmenopausal is defined as 12 consecutive months with no menses without an alternative medical cause. Highly effective methods of birth control are defined as those with 99% or greater efficacy and includes: Use of hormonal contraception that inhibits ovulation, administered orally, by injection, implant, transdermal patch, or vaginal ring Vasectomized male partner Sexual abstinence, only if it is the participant's consistent and preferred lifestyle Infertile partner, confirmed by medical evaluation 7. Participants must agree to abstain from egg or sperm donation through 60 days after administration of the last dose of study drug. 8. Able to read and sign a written informed consent form (ICF). 7.3 Exclusion Criteria Participants who meet any of the following criteria will be excluded from the study. 1. Receiving any nonapproved agent intended for treatment of fibrosis in IPF or participation in other treatment clinical trials. 2. Clinical evidence of active infection within 30 days of screening, including but not limited to bronchitis, pneumonia, or sinusitis that can affect FVC measurement during screening. 3. Known acute IPF exacerbation, or suspicion by the Investigator of such, within 3 months of screening. 4. The extent of emphysema is greater than the fibrotic changes on the most recent HRCT scan as determined by PI. 5. Any medical condition, not limited to cardiac, hepatic, renal disease or malignancy, in recent months that will make the participants unsuitable for the study, as judged by the PI. 6. Any of the following liver test results above the listed specified limits: total bilirubin \>2× the upper limit of normal (ULN); aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3× ULN; alkaline phosphatase (ALP) \> 2.5× ULN, pending PI's discretion. 7. Hemoglobin \< 10.0 g/dL. 8. Pregnant or lactating. 9. Likely to undergo lung transplantation during the study (being on transplantation list is acceptable). 10. Currently receiving and expected to remain on treatment during the study with drugs interacting with artesunate including amodiaquine, and efavirenz, nevirapine and ritonavir.

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Conditions

The condition(s) this trial relates to.

Cough Dyspnea Fibrosis Hypoxia idiopathic pulmonary fibrosis

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stanford University

    RECRUITING

    Stanford, California, 94305, United States

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