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Condition Guide

New Treatments & Clinical Trials for Malaria

Last updated June 2026Data from ClinicalTrials.gov133 active trials
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Malaria kills over 600,000 people each year, mostly young children in sub-Saharan Africa. Current treatment relies on artemisinin-based drugs, but resistance is spreading in Southeast Asia. Researchers are working on vaccines, long-acting prevention drugs, and new treatments that work when resistance emerges.

What's actually going on in research

Trials are testing next-generation antimalarials that target parasites resistant to artemisinin, long-acting injectable drugs for seasonal prevention, transmission-blocking vaccines, and combinations that kill parasites faster. The RTS,S vaccine is now being rolled out in high-burden countries, and a second vaccine, R21, was approved in 2023. Studies are also testing monoclonal antibodies for prevention during pregnancy and infancy.

Next-generation antimalarials

New drugs are being tested that kill parasites through different mechanisms than artemisinin. These include compounds that block parasite protein production and drugs that work in a single dose.

Long-acting prevention

Injectable drugs that last months could protect people during malaria season without daily pills. Trials are testing whether these reduce infections in children and pregnant women in high-transmission areas.

Transmission-blocking approaches

Vaccines and drugs designed to prevent mosquitoes from spreading malaria after they bite an infected person. These could reduce transmission even if they don't fully protect individuals from infection.

What to know before you search

Eligibility depends on whether you live in or travel to malaria-endemic areas, age, pregnancy status, and for treatment trials, confirmed malaria infection and disease severity.

What types of trials are currently open

  • Treatment trialsTesting new antimalarial drugs or drug combinations to see if they clear parasites faster or work against resistant strains.
  • Prevention trialsTesting vaccines, long-acting injectable drugs, or new formulations of existing prevention medications in areas where malaria is common.
  • Severe malaria trialsTesting treatments for life-threatening malaria complications like cerebral malaria or severe anemia, often in hospitalized children.
  • Pregnancy trialsTesting drugs or vaccines to prevent malaria in pregnant women, who face higher risk of severe disease and pregnancy complications.
  • Transmission studiesFollowing communities to measure how interventions reduce malaria spread and whether parasites are developing drug resistance.

Recently added Malaria trials

RecruitingSafety & dosing / Early efficacy

Take hydroxyurea at increasing doses to find the safest effective level

NOHARM MTD is an extension of a previous study for children with Sickle Cell Anemia (SCA) who were enrolled in the NOHARM study. All children enrolled in NOHARM received hydroxyurea treatment at a fixed daily dose of 20 mg/kg/day. This dose was selected as a likely safe dose, but does not escalate hydroxyurea to maximum tolerated dose "MTD" as is commonly done in the US. Without this information, we cannot know whether hydroxyurea treatment at the MTD would be feasible (since it requires closer monitoring to avoid hematological toxicities), safe (since adverse events may be greater with MTD, risk of malaria may be altered by MTD, and risk of infections as a result of neutropenia could also be greater with MTD) or beneficial (MTD is associated with higher hemoglobin and fetal hemoglobin concentration).

Kampala, Uganda
RecruitingTesting effectiveness

Receive three injections of an experimental malaria vaccine

A randomized double blind, placebo-controlled study to assess the safety, tolerability, immunogenicity, and protective efficacy of 1, 6, 29-day PfSPZ-LARC2 Vaccine regimen given at a dose of 2 x10\^5 PfSPZ or placebo in healthy WOCBP, who are on pregnancy prevention during vaccination, but report plans to become pregnant in the near future. Participants will be randomized into two arms. Arm 1: (n= 150) will receive 3 doses of PfSPZ-LARC2 Vaccine (2x10\^5 PfSPZ) via direct venous inoculation (DVI) at 1, 6, 29 days. Arm 2: (n= 150) will receive 3 doses of normal saline (placebo) injection via DVI at 1, 6, 29 days. All volunteers will receive antimalarial treatment with artemether/lumefantrine (AL) \~2 to 4 weeks prior to 1st (study day -14 to -28) and \~2 weeks prior to 3rd injection (study day 44). Participants will be monitored for safety, tolerability, immunogenicity, and malaria infection during the follow-up period. Participants will also be monitored closely for pregnancy as well post 3rd injection through the entire planned study duration (2 years post dose 1). If pregnant, women will be followed during the course of their pregnancy and for at least 1 year post-delivery (as well as their offspring) for safety and malaria infection. Malaria infections in participants and their offspring will be classified as asymptomatic or symptomatic (clinical cases).

Bamako, Mali
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