New malaria pill shows promise in early trial
NCT ID NCT07235020
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 2 trial tested an experimental drug called INE963 in 52 adults with uncomplicated Plasmodium falciparum malaria. The main goal was to see how quickly the drug clears malaria parasites from the blood. Researchers also checked the 28-day cure rate. The study is part of a larger platform trial and has already been completed.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- INE963 (an experimental antimalarial drug taken by mouth)
- What this could lead to
- If successful, this could point toward a new oral treatment for uncomplicated malaria, potentially offering an alternative to existing drugs.
- What could go wrong
- This is a small, early-phase trial (Phase 2) with only 52 participants, so results may not apply broadly. The drug may not work as well in larger studies or in different populations.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
52 people
The number who actually took part.
- Started
-
Jan 2024
- Finished
-
Feb 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 to 100 years
- Sex
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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 Hide 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 and female patients ≥18 years of age at screening. 2. Patients must have acute uncomplicated P. falciparum malaria mono infection at screening confirmed by a parasite count between 5,000 to 150,000 asexual parasite count/μl of blood for P. falciparum 3. Patients must weigh between 40 kg and 90 kg. 4. Axillary temperature ≥ 37.5ºC or oral/tympanic/rectal temperature ≥ 38.0ºC; or history of fever during the previous 24 hours. Exclusion Criteria: 1. Patients with signs and symptoms of severe/complicated malaria at screening or mixed Plasmodium infection (i.e., infection with more than one malaria species) at screening 2. Moderate to severe anemia, chronic hemoglobinopathy (Hemoglobin level \< 8 g/dL), or known chronic underlying disease such as sickle cell disease at screening 3. Known clinically significant liver disease (e.g., chronic hepatitis, liver cirrhosis (compensated or decompensated), history of hepatitis B or C, hepatitis A or B vaccination in the last 3 months, known gallbladder or bile duct disease, acute or chronic pancreatitis. Clinical or laboratory evidence of any of the following at screening: * AST/ALT \> 3 x the upper limit of normal range (ULN), regardless of the level of total bilirubin * AST/ALT \> 1.5 and ≤ 2 x ULN and total bilirubin is \> ULN * Total bilirubin \> 2 x ULN, regardless of the level of AST/ALT 4. Any known/suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection at screening. 5. Pregnant or nursing (lactating) women, women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using methods of effective contraception, and sexually active patients not willing to practice effective contraception. 6. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as: * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker * History of familial long QT syndrome or known family history of Torsades de Pointe. * Resting heart rate (physical exam or 12 lead ECG) \< 50 bpm Other protocol-defined inclusion/exclusion criteria may apply.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Novartis Investigative Site
Banfora, Burkina Faso
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Novartis Investigative Site
Azaguié, BP 173, Côte d’Ivoire
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Novartis Investigative Site
Lambaréné, BP 242, Gabon
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Novartis Investigative Site
Navrongo, VWJ6+8WF, Ghana
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Novartis Investigative Site
Kisumu, 40100, Kenya
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Novartis Investigative Site
Kampala, Uganda
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Two-Drug malaria pill combo put to the test
- Triple threat: could three malaria drugs together beat resistance?
- New malaria combo shows promise in kids – could fight drug resistance
- New malaria pill shows promise in large trial
- New malaria combo shows promise in clearing parasite