New malaria pill shows promise in early trial
NCT ID NCT07545681
First seen Jun 25, 2026 · Last updated Jul 09, 2026 · Updated 3 times
Summary
This phase 2 study tests a new antimalarial drug called GSK3772701 in 70 adults with uncomplicated P. falciparum malaria. Participants receive different doses for 1 to 3 days to see if it is safe and clears the parasite. The goal is to find a new treatment option that could work against drug-resistant malaria.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- GSK3772701 (a pyrrolidinamide antimalarial drug)
- What this could lead to
- If successful, this could provide a new treatment option for uncomplicated malaria, potentially helping to overcome drug resistance.
- What could go wrong
- This is an early phase 2 trial with only 70 participants, so results may not apply to everyone. The drug may cause side effects or fail to clear the infection effectively.
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
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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: * Male and female patients aged 18 to 65 years. * Presence of malaria due to mono-infection with P. falciparum confirmed by: * Fever, as defined by axillary temperature \>=37.5°C or oral/tympanic temperature \>=38°C and, * Microscopically confirmed P. falciparum malaria parasite mono-infection, * A parasite count between 2,000 to 60,000 asexual parasite count/µL of blood for P. falciparum. * Have a BMI between \>=18 and \<=30 kg/m2. * Able to swallow oral medication. * Signed informed consent, acknowledging understanding and willingness to comply with the requirements of the study. If the patient is unable to write, thumb print consent, signed by an impartial witness is permitted according to local ethical considerations. * Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. * A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: * Is a woman of non-childbearing potential (WONCBP) or * Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method, from Study Day 1, and during the study intervention period (40 +/-3 days). Exclusion Criteria: * Patients with signs and symptoms of severe/complicated malaria according to the WHO 2024 Criteria. * Mixed Plasmodium infection, i.e., infection with more than one malaria (plasmodium) species (by microscopy; participant to be withdrawn from study treatment if PCR subsequently indicates presence of mixed infection). * Abnormal values: QTcF \>450 msec or QTcF \>480 msec for patients with bundle branch block. * Any clinically significant ECG abnormalities at Screening unrelated to malaria (including but not limited to, second degree AV block (Mobitz Type 2), complete heart block, ST changes, atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, prolonged QT interval. * History of malignancy (or current malignancy) of any organ system (other than localized carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * Creatinine \>=2 x ULN. * Significant illness within two weeks prior to screening. * Positive HIV antibody test at screening, or history of HIV infection based on past positive test result, clinical record or current treatment. * Severe vomiting, defined as more than 3 times in the 24 hours before screening or inability to tolerate oral treatment. * Severe diarrhoea defined as more than 3 watery stools per day in the 24 hours before screening. * Known history or evidence (based on clinical examination or investigation) of uncontrolled active cardiovascular disease (including hypertension), respiratory disease (including active tuberculosis even if treatment is ongoing), liver cirrhosis or liver disease (based on prior investigation, clinical signs and/or interpretation of liver enzymes), other active hepatic, renal, gastrointestinal, immunological, neurological, endocrine, infectious, or psychiatric disease. * Anaemia (Hb \<=8.0g/dl) or known clinically important chronic underlying haematological disease such as sickle cell disease at screening. * Significant chronic medical conditions which in the opinion of the investigator preclude enrolment into the study. * Have received any antimalarial treatment in the preceding 6 weeks (see Section 6.10), as determined by history or medical record. * Prior enrolment in this study and receipt of treatment with GSK3772701. * Use of other investigational drugs at the time of enrolment, or within 6 weeks, or 5 half-lives prior to enrolment into this study, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. * History of hypersensitivity to the study drug or drug formulation and capsule (Hypromellose (hydroxypropyl methylcellulose)) constituents. * History of drug or alcohol abuse within 3 months prior to dosing, or clinical evidence of such abuse. * Participants who in the opinion of the Investigator are unsuitable for participation in the study or cannot be enrolled due to logistical reasons. * ALT \>2.0 x ULN. * Total bilirubin \>1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5xULN as long as direct bilirubin is \<=1.5xULN. * Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). * Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention. * Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention. Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained. • Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention. Note: Test is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
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Other studies related to the condition(s) this trial covers.
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