India Pharma Outlook Team | Friday, 14 November 2025
Novartis announced positive Phase III results on its innovative malaria drug GanLum. This research, referred to as KALUMA, demonstrated that GanLum achieved its primary objective and was as effective, at least, as existing standard therapies.
The PCR-corrected cure rate was found to be 97.4, which is more than the standard care of 94.0. Upon the analysis of a per-protocol approach, there was a rise in the cure rate of 99.2 per cent and 96.7 per cent in the control, respectively.
A total of 1,668 participants of 12 African countries participated in the trial. The drug was administered in a sachet to the patients daily on a three-day basis.
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It was discovered by the researchers that GanLum was very effective against the malaria strains that are identified to cause early drug resistance and it rapidly killed the mature gametocytes, which are the parasite stage that causes transmission. These results were published in the 2025 American Society of Tropical Medicine and Hygiene meeting, which is of interest since Africa is facing the increasing resistance cases against antimalarial drugs.
According to Dr Abdoulaye Djimde, GanLum can be the largest breakthrough in decades in the treatment of malaria. Novartis pointed out that a first-in-class drug, ganaplacide, has no fewer than three methods through which it functions, by interfering with the internal protein transport machinery of the parasite. Novartis will engage in the process of regulatory approvals by fast-tracking.
The therapy already has Fast Track and Orphan Drug Designation of the US FDA. Assuming it passes, it would be the first substantial malaria treatment innovation since the artemisinin-based therapies were first invented over 25 years ago. Medicines for Malaria Venture (MMV) and the WANECAM2 consortium are the supporters of the program. According to MMV CEO Dr Martin Fitchet, Phase III results by GanLum are a major milestone to a new tool that will enable it to stay ahead of resistance.
