There’s a sense of cautious optimism rippling through the global health community this week, as two major breakthroughs in malaria treatment have emerged—offering hope in the ongoing struggle against a disease that still claims hundreds of thousands of lives each year. On November 13, 2025, Swiss pharmaceutical giant Novartis announced the results of a late-stage clinical trial for a new antimalarial drug combination, ganaplacide/lumefantrine (GanLum), while just a day earlier, researchers in Gabon unveiled a promising single-dose, four-drug regimen at the American Society of Tropical Medicine and Hygiene (ASTMH) annual meeting.
Both developments arrive at a critical juncture. According to the World Health Organization, malaria caused approximately 597,000 deaths worldwide in 2023, with the vast majority of fatalities occurring in sub-Saharan Africa and most victims being children under five. The fight against malaria, once buoyed by effective artemisinin-based combination therapies (ACTs), has reached a plateau in recent years. Resistance to these mainstay drugs is rising, particularly in countries such as Eritrea, Rwanda, Uganda, and Tanzania, threatening to undo decades of progress.
Novartis’s GanLum represents what many experts are calling the first major innovation in malaria therapeutics in over 25 years. The Phase III trial, conducted in partnership with the Medicines for Malaria Venture (MMV), enrolled 1,688 children and adults across 12 African countries. The results are striking: GanLum achieved a PCR-corrected cure rate of 97.4% at Day 28, and 99.2% under per-protocol analysis. By comparison, the current standard of care—an artemisinin-based combination—registered a cure rate of about 94% in the same trial.
What sets GanLum apart is its novel mechanism of action. The new molecule, ganaplacide, disrupts the malaria parasite’s internal protein-transport system within red blood cells and targets mature gametocytes, the sexual forms responsible for transmission back to mosquitoes. In simple terms, not only does the drug treat the infected individual, but it may also reduce the spread of malaria within communities. Safety data from the trial were reassuring, with Novartis reporting that adverse events were consistent with typical malaria symptoms and similar to those seen with existing therapies.
“GanLum addresses rising resistance to artemisinin-based therapies, a growing concern especially in sub-Saharan Africa,” Novartis stated, echoing the sentiments of many in the field. George Jagoe of MMV described GanLum as a pivotal tool in preventing a healthcare crisis reminiscent of previous setbacks in malaria control, according to reporting by multiple outlets.
Novartis plans to submit GanLum for regulatory approval within the next 12 to 18 months, aiming to supply the drug on a not-for-profit basis in malaria-endemic countries. If approved and distributed at scale, GanLum could become a vital new weapon in the global arsenal against malaria, particularly in regions where resistance to artemisinin is already undermining current treatments.
But GanLum isn’t the only headline-grabbing advance this week. In Gabon, a team led by Dr. Ghyslain Mombo-Ngoma of the Medical Research Center of Lambaréné (CERMEL) reported the results of a Phase 3 clinical trial testing a single-dose treatment that combines four widely available malaria drugs: sulfadoxine, pyrimethamine, artesunate, and pyronaridine (collectively known as SPAP). The trial, which ran from May 2024 to October 2025 and involved more than 1,000 patients—half of them under 10 years old—showed a 93% cure rate 28 days after treatment with the single-dose regimen, compared to a 90% cure rate for the standard three-day ACT (artemether/lumefantrine).
Dr. Mombo-Ngoma explained the significance: “We found that our single-dose treatment was just as effective as the standard course that typically requires taking six doses spaced out over three days, which many patients never complete.” He emphasized that the four-drug combination targets multiple vulnerabilities in the malaria parasite, making it a formidable opponent to drug resistance. “Another key advantage is that our single-dose cure was accomplished with drugs that are currently available to malaria treatment programs across Africa—and relatively affordable as well,” he added.
Non-adherence to multi-day treatment regimens is a persistent problem in malaria control, often leading to incomplete cures and giving the parasite more opportunities to develop resistance. The single-dose approach, if validated in larger studies and implemented widely, could tackle both adherence and resistance simultaneously. Notably, no serious adverse events related to the study drugs were reported in the Gabon trial, further bolstering the case for broader adoption.
“This study is also a reminder that, at a time when the entire field of global health is facing enormous headwinds, ASTMH members are keeping their focus on research that can support better health for millions of people in low- and middle-income countries,” said ASTMH President David Fidock, who leads a WHO advisory group on antimalarial drug resistance.
These advances come as malaria cases and deaths, which had fallen dramatically from 2000 to 2015, are once again on the rise. WHO data show that in 2023 there were 263 million cases and 597,000 deaths, up from 216 million cases and 445,000 deaths in 2016. Funding shortfalls and logistical challenges further complicate the fight, especially in remote regions where infrastructure is weak and health systems are under strain.
Experts caution, however, that promising results in clinical trials are only the first step. Regulatory approvals must be secured in each country, and scaling up production and distribution—particularly in sub-Saharan Africa—will require robust supply chains, financing, and patient education. Treatment abandonment, where patients do not complete all prescribed doses, remains a stubborn obstacle. As Dr. Mombo-Ngoma noted, “What I hope is that, if we continue to have success with this single-dose cure, it can serve as a bridge to the new treatments now under development—something we can deploy very soon while we await the arrival of other options.”
Meanwhile, Novartis’s commitment to a not-for-profit rollout of GanLum, if approved, could help ensure that cost does not become a barrier for the hardest-hit countries. The company’s collaboration with MMV underscores a growing recognition that public-private partnerships are essential for tackling diseases that disproportionately affect the world’s poorest populations.
Both the GanLum and SPAP single-dose approaches represent a new chapter in the fight against malaria—a disease that, despite being preventable and treatable, still exacts a devastating toll. With drug resistance on the rise and adherence challenges ever-present, the global health community is watching these developments closely, hopeful that they will mark the beginning of a long-awaited turnaround in malaria control and, ultimately, save countless lives.
