Ganaplacide lumefantrine combination delivers cure rates above WHO standards, offering new hope against growing artemisinin resistance.
London, 13 November 2025 – A major step forward in the global fight against malaria has arrived. Novartis has reported strong Phase 3 results for its new malaria combination therapy, GanLum, marking the first potential novel treatment for the disease in more than two decades. The drug met its primary goal of matching the effectiveness of the current standard of care while delivering cure rates above the World Health Organization’s recommended 90–95 percent threshold.
Malaria remains one of the world’s most dangerous infectious diseases, causing nearly 600,000 deaths annually. In the late 1990s and early 2000s, deaths were significantly higher due to drug resistance. George Jagoe of Medicines for Malaria Venture (MMV) noted that the lack of effective therapies directly contributed to nearly 2 million deaths per year during that time. Coartem, introduced in 1999, dramatically improved survival, but resistance to its artemisinin component is now emerging in several African regions.
GanLum, combining the novel molecule ganaplacide with the long-established anti-malarial lumefantrine, offers a much-needed new mechanism of action. Ganaplacide disrupts the parasite’s internal protein transport system and also targets the stage when the parasite can be picked up by mosquitoes, helping reduce transmission.
Strong Phase 3 Results Across Africa
The Phase 3 trial enrolled 1,688 adults and children across 34 sites in 12 African countries. GanLum was given once daily for three days, compared against standard Coartem therapy.
Key findings:
- 4 percent of patients treated with GanLum plus Coartem were parasite-free at 28 days (corrected analysis).
- Standard Coartem alone achieved 84 percent under the same criteria.
- Safety was comparable to existing treatment, with no new concerns.
Researchers noted that these results not only demonstrate non-inferiority but also show promise in areas where resistance to artemisinin-based therapies is already rising.
A Critical New Tool Against Resistance
Experts stress that GanLum’s arrival is timely. Countries such as Kenya, Rwanda, and Uganda already show concerning levels of resistance to artemisinin. David Fidock of Columbia University emphasized the need to position GanLum early in treatment protocols in high-risk regions.
MMV’s Jagoe compared GanLum to a “fire extinguisher”—a vital tool ready when resistance escalates further.
Next Steps Toward Approval
Novartis plans to seek regulatory approval through Swissmedic, mirroring the approach used for Coartem Baby. The company is also in discussions with regulators across Sub-Saharan Africa to accelerate access.
GanLum was developed with extensive collaboration, including support from MMV, the WANECAM2 consortium, the European Union’s clinical trials partnership program, the German Aerospace Center, and the UK Department of Health and Social Care.
If approved, GanLum could usher in a new chapter in malaria treatment, offering hope to millions while strengthening global preparedness against drug-resistant strains.
