Novartis’ GanLum Achieves 97% Cure Rate In Phase III Trial, Paving The Way For The Next Generation Of Malaria Treatments

Novartis announced positive topline results from KALUMA, its Phase III clinical trial evaluating KLU156 (ganaplacide/lumefantrine, or GanLum), a novel non-artemisinin antimalarial developed in collaboration with Medicines for Malaria Venture (MMV). The study met its primary endpoint of non-inferiority to the current standard of care, achieving a 97.4% PCR-corrected cure rate versus 94.0% with standard treatment. Based on per-protocol analysis, cure rates were 99.2% for GanLum and 96.7% for standard therapy, underscoring the treatment’s strong efficacy profile.

“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. “Drug resistance is a growing threat to Africa, so new treatment options can’t come a moment too soon.”

Conducted in 1,688 adults and children across 34 sites in 12 African countries, the study administered GanLum as a once-daily sachet for three days. Results showed that the treatment was highly effective against mutant malaria parasites linked to partial drug resistance and demonstrated rapid action against mature gametocytes, which drive malaria transmission. These findings come at a critical time, as drug-resistant malaria strains continue to rise across Africa, threatening progress made in malaria control efforts. Data from the trial were presented at the American Society of Tropical Medicine and Hygiene 2025 meeting.

“Drug-resistant parasites threaten the efficacy of medicines that have helped to control malaria for decades,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “Together with our partners, we’ve gone further to develop a new class of antimalarial with an entirely new mechanism of action, which has the potential to both treat the disease and block transmission. We look forward to working with health authorities to bring this innovation to patients as soon as possible, helping close a critical gap in malaria care for those who need it most.”

GanLum combines ganaplacide, a first-in-class imidazolopiperazine compound that disrupts the parasite’s protein transport systems inside red blood cells, with a new long-acting lumefantrine formulation. The treatment represents a potential first major advance in malaria therapy in over 25 years, since the introduction of artemisinin-based combinations. Novartis, supported by MMV and the WANECAM2 consortium, plans to seek regulatory approvals globally, with the therapy already holding Fast Track and Orphan Drug Designations from the U.S. FDA. If approved, GanLum could become a transformative new weapon in the global fight against malaria.

“Antimalarial drug resistance is a ticking clock; without action today, lives will be lost,” said Dr Martin Fitchet, CEO of MMV. “GanLum’s Phase III results are a key step towards a new tool to help stay ahead of resistance. Working with Novartis and our partners, we’re committed to turning this promise into impact.”