Novartis Breaks 25-Year Antimalarial Drought with GanLum, Achieving Over 99% Cure Rate in Phase III Trial

Nov 13, 2025 10:52 CST Updated 10:52

Novartis

Drug Development and Manufacturing

During the Taizhou Medical Expo from November 28th to 30th, Tongxiyi will organize 20+ sessions.Special Topic Docking and Exchange Activities, inviting 300+ exhibitors to showcase, welcome to register for speaking and exhibition.

Malaria kills hundreds of thousands of children annually, but no major new antimalarial drugs have emerged in the past 25 years.

Now, Novartis says it has a drug like this.

This Swiss pharmaceutical giant revealed on November 12 that its newly developed therapy cured over 99% of malaria cases in a Phase III study. Novartis stated that the candidate drug may also prevent the spread of drug resistance, which is increasingly becoming a threat in sub-Saharan Africa.

This new drug is calledGanLum, composed of ganaplacide and lumefantrine, is expected to be the biggest innovation in malaria treatment since the introduction of artemisinin-based combination therapies in 1999.

GanLum will provide a much-needed new weapon in the fight against malaria. Professor of Microbiology, Immunology, and Medicine at Columbia UniversityDavid Fidock stated that artemisinin-based drugs remain highly effective, but resistance to them is spreading, particularly in eastern and southern Africa.

"We must be prepared with new drugs to address the growing issue of drug resistance," said Fidock, who is also the president of the American Society of Tropical Medicine and Hygiene.

GanaplacideIt is a novel fast-acting compound. It is combined with a new formulation of lumefantrine, an antimalarial drug currently used in artemisinin-based therapy. Novartis has collaborated with Medicines for Malaria Venture, a Switzerland-based non-profit organization.(MMV, Medicines for Malaria Venture)Co-developed this new drug, the organization is dedicated to researching, developing, and promoting affordable malaria treatment solutions.

Malaria is a disease caused by parasites transmitted by mosquitoes. Although this disease is no longer rampant in wealthy countries, it remains one of the major fatal diseases in developing countries.

According to the World Health Organization, there were approximately 263 million cases of malaria in 2023, an increase of 11 million compared to 2022, resulting in about 597,000 deaths. Approximately three-quarters of the deceased were children under the age of 5.

Head of Global Health Development at NovartisSujata Vaidyanathan stated that Ganaplacide can disrupt the internal protein transport system of the malaria parasite — a system essential for the parasite's survival within red blood cells.

According to laboratory test data, the drug is effective against both common and drug-resistant strains of malaria parasites. It also acts on the stages of the parasite that can transmit the disease between humans.

In Phase III clinical trials,GanLum was tested in 1,688 adults and children across 12 African countries. Subjects took one sachet of granules daily for three consecutive days.

The subjects included those weighing at least 10 kilograms.(About two years old)Children. Novartis stated that it is developing formulations suitable for younger children.

Novartis and MMV plan to bring the drug to market within 1 to 1.5 years.

Executive Vice President of MMV Acquisition and Product ManagementGeorge Jagoe said,The next focus is to deliver the drugs to countries where resistance is emerging or about to emerge, such asRwanda and Uganda.

References:

First New Malaria Drug in Years Performs Strongly in Late-Stage Testing