Malaria infections in sub-Saharan Africa are increasingly showing resistance to artemisinin-based therapies, posing a significant threat to the effectiveness of antimalarials against the mosquito-transmitted parasite.
However, a novel non-artemisinin antimalarial from Novartis has demonstrated that it is as effective as standard treatment.
On November 12, 2025, Novartis announced positive results from KALUMA, a Phase III study for the new malaria treatment KLU156 (ganaplacide/lumefantrine, or GanLum).
This drug was developed with Medicines for Malaria Venture and met the study's primary non-inferiority endpoint relative to the current standard of care. The treatment achieved a 97.4% PCR-corrected cure rate using an estimand framework, compared to 94% with standard of care.
This data equates to cure rates of 99.2% and 96.7% respectively, based on conventional per-protocol analysis.
"GanLum could represent the biggest advance in malaria treatment for decades, with high efficacy against multiple forms of the parasite as well as the ability to kill mutant strains that are showing signs of resistance to current medicines," said Dr Abdoulaye Djimdé, Professor of Parasitology and Mycology at the University of Science, Techniques and Technologies of Bamako, Mali, in a press release.
"Drug resistance is a growing threat to Africa, so new treatment options can't come a moment too soon."
GanLum is a combination of two compounds that attack the malaria parasite on multiple fronts: ganaplacide, a novel compound with an entirely new mechanism of action, and a new once-daily formulation of the existing antimalarial lumefantrine, a longer-acting treatment.
Ganaplacide is believed to work by disrupting the parasite's internal protein transport systems, which are essential to its survival within red blood cells.3 It belongs to a class of compounds called imidazolopiperazines, first identified as potential antimalarials after a groundbreaking screen of 2.3 million molecules to find drug candidates at Novartis labs in San Diego, California.
Novartis plans to seek regulatory approvals from health authorities for GanLum as soon as possible.
If approved, the drug could be used to treat international travelers returning to the United States after being infected.
For example, in Florida, 43 travel-related malaria cases have been confirmed in 2025, 15 related to travel to Nigeria.
From a malaria prevention option, about 24 countries are now offering malaria vaccinations, but not the USA.
