Novartis’ GanLum Achieves Phase III Success, Marking Potential First Major Malaria Treatment Breakthrough in 25 Years

Novartis has reported positive Phase III results for its investigational malaria therapy KLU156 (ganaplacide/lumefantrine, or GanLum), a non-artemisinin antimalarial developed in collaboration with Medicines for Malaria Venture (MMV). The drug met its primary endpoint in the KALUMA study, demonstrating non-inferiority to Coartem®, the current standard of care.

GanLum achieved a PCR-corrected cure rate of 97.4% under an estimand framework and 99.2% in conventional per-protocol analysis, compared to 94.0% and 96.7%, respectively, for Coartem.

If approved, GanLum could represent the first major advance in malaria therapy since 1999, with potential to target drug-resistant parasites and block transmission.

Study Overview

The KALUMA trial enrolled 1,668 adults and children across 34 sites in 12 African countries, comparing once-daily, three-day doses of GanLum with the standard artemether-lumefantrine regimen.

Key findings include:

• 97.4% PCR-corrected cure rate (estimand analysis) vs 94.0% for Coartem
• 99.2% per-protocol cure rate vs 96.7% for Coartem
• Similar safety profile to standard of care
• Rapid efficacy against drug-resistant parasite strains and mature gametocytes, the stage responsible for transmission

The study results were presented at the American Society of Tropical Medicine and Hygiene (ASTMH) 2025 Annual Meeting.

Expert Perspectives

“GanLum could be the most significant malaria advance in decades,” said Dr. Abdoulaye Djimdé, Professor of Parasitology and Mycology, University of Bamako, Mali. “Its ability to combat resistant strains and multiple parasite stages is critical as Africa faces a rising threat of drug resistance.”

“We have developed a new class of antimalarial with a novel mechanism of action that could both treat infection and prevent transmission,” said Dr. Shreeram Aradhye, President of Development and Chief Medical Officer at Novartis.

“Drug resistance is a ticking clock,” added Dr. Martin Fitchet, CEO of MMV. “GanLum’s success in Phase III is a key step toward staying ahead of that threat.”

Mechanism and Innovation

GanLum combines two compounds:

• Ganaplacide, a first-in-class molecule that disrupts the malaria parasite’s internal protein transport system — a mechanism distinct from existing therapies.
• Lumefantrine, reformulated into a once-daily granule form for improved dosing convenience.

Ganaplacide was discovered after screening 2.3 million molecules at Novartis’ research center in San Diego.

Next Steps

Novartis plans to seek regulatory approvals for GanLum as soon as possible. The therapy has already received Fast Track and Orphan Drug Designation from the U.S. FDA (2022).

The development program is supported by MMV and the WANECAM2 consortium, funded by the European & Developing Countries Clinical Trials Partnership, with co-funding from the German Aerospace Center and the UK Department of Health and Social Care.

Context

According to the World Health Organization, malaria caused 263 million cases and 597,000 deaths globally in 2023, with nearly three-quarters of fatalities among children under five in Africa.

Novartis has delivered over 1.1 billion courses of Coartem since 1999, largely at no profit, and continues to invest in non-artemisinin antimalarial research, with four additional candidates under development.

About Novartis

Novartis is a global medicines company focused on reimagining medicine to improve and extend lives. Its treatments reach nearly 300 million people worldwide.

About MMV

Medicines for Malaria Venture (MMV) is a Swiss non-profit dedicated to discovering, developing, and delivering accessible, affordable antimalarial drugs. Since 1999, MMV’s collaborations have helped over 1.3 billion people access effective treatments.

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