Novartis AG has recently unveiled groundbreaking data from its KALUMA Phase 3 study, highlighting the promising potential of KLU156 (GanLum), an experimental treatment for malaria. This innovative medication represents a significant stride in the global fight against this devastating disease, especially in an era marked by increasing drug resistance.
Novartis's New Malaria Treatment Shows Impressive Results
On November 13, 2025, Novartis announced compelling results from its KALUMA Phase 3 clinical trial for KLU156, a novel malaria treatment combining ganaplacide, a compound with a unique mechanism of action, and a new, once-daily formulation of lumefantrine. This dual-component therapy, developed in collaboration with Medicines for Malaria Venture (MMV), achieved its primary goal by demonstrating non-inferiority compared to the current gold-standard treatments.
The trial's findings revealed an impressive 97.4% PCR-corrected cure rate for GanLum, outperforming the 94.0% achieved by standard care. When analyzed through conventional per-protocol methods, these figures further ascended to 99.2% and 96.7% respectively. The study enrolled 1,688 adults and children, who received GanLum in a granular sachet format once daily for three days.
Further detailed analysis underscored GanLum's high effectiveness against mutant malaria parasites, which are increasingly responsible for partial drug resistance. The treatment also exhibited a swift impact on mature gametocytes, the parasitic stage crucial for transmission, suggesting its potential to curb the spread of malaria effectively. Importantly, the safety profile of GanLum was found to be consistent with existing treatments, with adverse events aligning with the underlying disease.
Professor Abdoulaye Djimdé, a distinguished expert in Parasitology and Mycology at the University of Science, lauded GanLum as potentially the most significant advancement in malaria treatment in decades. He emphasized its high efficacy against various forms of the parasite, including those developing resistance to current medications. Novartis is now actively pursuing regulatory approvals from health authorities, aiming to make GanLum available as soon as possible. The U.S. Food and Drug Administration had already granted Fast Track and Orphan Drug Designations to the combination therapy in 2022.
If approved, GanLum would mark the first substantial innovation in malaria treatment since artemisinin-based combination therapies were introduced over a quarter-century ago. This development follows Novartis's recent achievement in July, when Swissmedic approved Coartem (artemether-lumefantrine) Baby, the first malaria medication specifically sanctioned for newborns and young infants.
This pioneering research by Novartis offers a beacon of hope in the ongoing battle against malaria. The development of GanLum, with its potent activity against drug-resistant strains and its capacity to disrupt transmission, underscores the critical importance of continuous innovation in global health. Such advancements not only promise to save countless lives but also provide a renewed sense of optimism for eradicating a disease that has plagued humanity for centuries.