First New Malaria Drug in Years Performs Strongly in Late-Stage Testing

Novartis said its experimental treatment cured more than 99% of malaria cases in the trial, marking a big step toward approval.

Malaria kills hundreds of thousands of children annually, yet there hasn’t been a major new drug to fight it in more than 25 years.

A microscopy slide used to count parasites in a patient sample.

Now, Novartis says it has one.

The Swiss company said Wednesday that a potential new treatment cured more than 99% of malaria cases in a late-stage study. The drug candidate may also be able to prevent the spread of drug resistance, a growing threat in sub-Saharan Africa, Novartis said.

The new drug, known as GanLum for

Ganaplacide is a novel rapid-acting compound. It is combined in the drug candidate with a new formulation of lumefantrine, an antimalarial currently used in artemisinin therapies. Novartis developed the new drug with the Medicines for Malaria Venture, a Swiss nonprofit that works to develop and deliver affordable treatments for the disease.

A microscopy slide used to count parasites in a patient sample.

Malaria is caused by parasites that are spread by mosquitoes. While no longer a scourge in wealthy countries, the disease remains a leading killer in the developing world.

There were about 263 million cases in 2023, 11 million more than in 2022, and 597,000 deaths, according to the World Health Organization. About three-quarters of those who die of malaria are children under 5 years old.

Ganaplacide disrupts the malaria parasite’s internal protein transport systems, which the parasite needs to survive in red blood cells, said Sujata Vaidyanathan, head of the global health development unit at Novartis.

In lab testing, the drug worked against the malaria parasite as well as drug-resistant forms. It also worked against the form of the parasite that transmits the disease from one person to another, Vaidyanathan said.

In its Phase 3 trial, GanLum was tested in 1,688 adults and children across 12 African countries. Subjects took a sachet of granules once a day for three days.

The drug was studied in children of at least 10 kilograms in weight, or about 2 years of age. Novartis said it is working on formulations for smaller children.

Novartis and MMV are aiming to have the drug on the market in one to 1½ years.

Then the priority will be to deliver it to countries where resistance is looming or on the horizon, said George Jagoe, MMV’s executive vice president of access and product management. Rwanda and Uganda are among countries where resistance is a growing concern, he said.

Write to Betsy McKay at betsy.mckay@wsj.com