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New malaria pill shows promise in large trial

NCT ID NCT05842954

Disease control Sponsor: Novartis Pharmaceuticals 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new malaria drug called KLU156 in over 1,700 adults and children with uncomplicated malaria. It compared KLU156 to a standard treatment, Coartem, to see if it works as well. Some participants continued taking KLU156 for up to two years to check its safety with repeated use.

What this could mean

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

Active substance
KLU156 (ganaplacide and lumefantrine combination)
What this could lead to
If successful, KLU156 could offer a new, once-daily, 3-day treatment option for uncomplicated malaria, potentially effective against drug-resistant strains.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The extension phase only includes patients who responded well initially, so long-term safety in all patients is unknown.

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

1,720 people

The number who actually took part.

Started

Mar 2024

Finished

Nov 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

2 months to 100 years

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 (Core phase) 1. Male or female patients ≥ 10 kg of body weight. 2. Microscopically confirmed diagnosis of uncomplicated P. falciparum malaria with an asexual P. falciparum parasitemia ≥ 1,000 and ≤ 200,000 parasites/µL at the time of pre-screening with or without other Plasmodium spp. co-infection. 3. Axillary temperature ≥ 37.5 ºC or oral temperature ≥ 38.0 ºC or tympanic/rectal temperature ≥ 38.5 ºC; or history of fever during the previous 24 hours (at least documented verbally) 4. Negative pregnancy test for patients of childbearing potential 5. Signed informed consent must be obtained before any assessment is performed; for minors, signed informed consent must be obtained from parent/legal guardian. If the parent/legal guardian is unable to read and write, then a witnessed consent according to local ethical standards is permitted. Patients who are capable of providing assent, must provide it along with parent/legal guardian consent or as per local ethical standards 6. The patient and/or their parent/legal guardian is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions and is likely to complete the study as planned. Key Exclusion criteria (Core phase) 1. Signs and symptoms of severe malaria according to WHO 2015 (World Health Organization) 2. Concurrent febrile illnesses (e.g., typhoid fever, known or suspected dengue fever, known COVID19) 3. Severe malnutrition. For patients ≥ 12 years: body mass index (BMI) \< 16.0. For children \< 12 years: less than 70% of median normalized WHO reference weight or very low mid-upper arm circumference (MUAC \< 115 mm) 4. Repeated vomiting (defined as \> 3 times in the 24 hours prior to start of screening) or severe diarrhea (defined as \> 3 watery stools in the 24 hours prior to start of screening) 5. Clinically relevant abnormalities of electrolyte balance which require correction, e.g., hypokalemia, hypocalcemia or hypomagnesemia 6. Anemia (hemoglobin level \<7 g/dL) 7. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs (e.g., Human immunodeficiency virus (HIV) patients on antiretroviral therapy (ART) or tuberculosis (TB) patients on treatment), or which may jeopardize the patient in case of participation in the study. 8. Any of the following: * Aspartate Aminotransferase/ Alanine Aminotransferase (AST/ALT) \> 3 x the upper limit of normal (ULN), regardless of the level of total bilirubin * Total bilirubin \> 3 x ULN * Resting QT interval corrected by Fridericia's formula (QTcF) \> 450 ms at screening 9. Prior antimalarial therapy or antibiotics with antimalarial activity within minimum of their five plasma half-lives (or within 4 weeks of screening if half-life is unknown) 10. History or family history of long QT syndrome or sudden cardiac death, or any other clinical condition known to prolong the QTc interval, such as history of symptomatic cardiac arrhythmias, clinically relevant bradycardia or severe heart disease 11. Pregnant or nursing (lactating) patients. Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

malaria Plasmodium falciparum malaria

As listed by the trial registrant

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

Uncomplicated plasmodium falciparum malaria

Contacts and locations

Locations

  • Novartis Investigative Site

    Banfora, Burkina Faso

  • Novartis Investigative Site

    Bobo-Dioulasso, 01, Burkina Faso

  • Novartis Investigative Site

    Nanoro, BP 18, Burkina Faso

  • Novartis Investigative Site

    Ouagadougou, 11 BP 218, Burkina Faso

  • Novartis Investigative Site

    Sabou, 06 BP 10248, Burkina Faso

  • Novartis Investigative Site

    Abidjan, 13BP972, Côte d’Ivoire

  • Novartis Investigative Site

    Agboville, BP 154, Côte d’Ivoire

  • Novartis Investigative Site

    Azaguié, BP 173, Côte d’Ivoire

  • Novartis Investigative Site

    Kimpese, Bas-Congo Province, Democratic Republic of the Congo

  • Novartis Investigative Site

    Kisantu, Bas-Congo Province, Democratic Republic of the Congo

  • Novartis Investigative Site

    Lubumbashi, Du Haut Katanga, 7010, Democratic Republic of the Congo

  • Novartis Investigative Site

    Kenge, Kwango, Democratic Republic of the Congo

  • Novartis Investigative Site

    Masi-Manimba, Kwilu, Democratic Republic of the Congo

  • Novartis Investigative Site

    Lambaréné, BP 242, Gabon

  • Novartis Investigative Site

    Libreville, BP 1437, Gabon

  • Novartis Investigative Site

    Kintampo, 92037, Ghana

  • Novartis Investigative Site

    Navrango, VWJ6+8WF, Ghana

  • Novartis Investigative Site

    Kombewa, 40102, Kenya

  • Novartis Investigative Site

    Nairobi, 00200, Kenya

  • Novartis Investigative Site

    Siaya, 2300, Kenya

  • Novartis Investigative Site

    Sotouba, Mali

  • Novartis Investigative Site

    Niamey, 8003, Niger

  • Novartis Investigative Site

    Gicumbi, Northern Province, 00114, Rwanda

  • Novartis Investigative Site

    Kigali, 0000, Rwanda

  • Novartis Investigative Site

    Kigali, BP 4560, Rwanda

  • Novartis Investigative Site

    Rubavu, Rwanda

  • Novartis Investigative Site

    Rusizi, Rwanda

  • Novartis Investigative Site

    Bagamoyo, Tanzania

  • Novartis Investigative Site

    Korogwe Tanga, Tanzania

  • Novartis Investigative Site

    Tanga, 5004, Tanzania

  • Novartis Investigative Site

    Tororo, 10102, Uganda

  • Novartis Investigative Site

    Nchelenge, Luapula Province, 70100, Zambia

  • Novartis Investigative Site

    Ndola, 71769, Zambia

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