London School of Hygiene & Tropical Medicine

In the world of antimicrobial resistance (AMR), most news is bad news, but a recent successful Phase III trial of a new antimalarial is a rare ray of sunshine. The scourge of malaria killed almost 600,000 people in 2023, most of them children in sub-Saharan Africa, and the rise in artemisinin resistance threatens to make this burden even worse. This is why the successful completion of Phase III trials for the new therapy GanLum (Novartis), a combination of ganaplacide and a reformulated lumefantrine, is such promising news.

Ganaplacide, a first-in-class imidazolopiperazine, works by disrupting the parasite’s protein transport system, which is essential for survival inside red blood cells, while lumefantrine provides long-acting protection. This dual mechanism not only clears parasites rapidly but also targets gametocytes, helping block transmission and reduce community spread.

Phase III trials across 12 African countries showed 97.4% PCR-corrected cure rates, including against strains with artemisinin-resistance mutations, along with faster parasite clearance than current therapies. If approved, GanLum would represent the first major antimalarial innovation in 25 years and would arrive at a critical moment as resistance accelerates.

Because malaria disproportionately affects low-income regions, equitable access will be essential. While specific access plans are still limited, the development was co-funded by Medicines for Malaria Venture and the European and Developing Countries Clinical Trials Partnership, both of which prioritise global access. This suggests that affordability and availability in endemic countries are likely to be central to future rollout plans.

References
[1] World Health Organisation. World Malaria Report 2024. Geneva: WHO; 2024.
[2] Novartis. Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum)… 2025.
[3] White NJ, et al. N Engl J Med. 2016;375(12):1152-1160.
[4] ClinicalTrials.gov. NCT05842954 Study Details. 2025.