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Malaria drug tafenoquine put to the test: is it safe for Long-Term use?

NCT ID NCT03320174

Knowledge-focused Sponsor: 60 Degrees Pharmaceuticals LLC 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at the long-term safety of tafenoquine, a drug used to prevent malaria. 600 healthy volunteers took either tafenoquine or a placebo daily for three days, then weekly for 51 weeks. Researchers monitored eye health and other side effects to see if the drug is safe for extended use.

What this could mean

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

Active substance
tafenoquine
What this could lead to
If successful, this could confirm that long-term use of tafenoquine is safe, supporting its use for preventing malaria.
What could go wrong
This is an early-phase safety study in healthy people, not patients. It cannot prove the drug works for any disease, and unexpected side effects may still emerge in larger or longer 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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

600 people

The number who actually took part.

Started

Oct 2017

Finished

Jul 2021

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 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Main Inclusion Criteria: 1. Completion of the written informed consent process (signed). 2. Male or female age 18 to 55 years inclusive, in good health as assessed by the Investigator. 3. Normal G6PD enzyme activity levels as defined by the parameters of the specific G6PD test employed at the local laboratory. 4. Negative HBsAg and HCV, HIV-1, HIV-2 antibody screen at the screening visit. 5. Negative serum pregnancy test. 6. Use acceptable method of birth control. 7. Hematology, biochemistry and urinalysis results at screening that are within the local laboratory reference range or, if outside the range, not clinically significant as judged by the Investigator in accordance with approved clinically acceptable laboratory ranges, documented prior to study start. 8. Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures. Main Exclusion Criteria: 1. History of allergy or intolerance to tafenoquine, primaquine or any excipients. 2. History of thalassemia or current or past history of methemoglobinemia or methemoglobin \>2% at screening. 3. History of eye disease or surgery 4. Having previously received hydroxychloroquine for skin conditions or rheumatological diseases, chloroquine for malaria, tamoxifen, amiodarone or other drugs that may affect the optic nerve/retina/cornea within 30 days or 5 half-lives (whichever is longer) of study start. There are no travel restrictions, but the choice of concurrent anti-malarial must be atovaquone-proguanil if the participant chooses to take a registered antimalarial drug while travelling. 5. Any current diagnosis of Axis I psychiatric disorders

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As listed by the trial registrant

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

Healthy volunteers

Contacts and locations

Locations

  • Linear Clinical Research

    Nedlands, Western Australia, 6009, Australia

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909, United States

  • Valley Retina Institute

    McAllen, Texas, 78503, United States

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