Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance

• GanLum was non-inferior to the standard of care, meeting its primary and key secondary endpoint.
• PCR-corrected adequate clinical and parasitological response at Day 29 (proportion of patients free from clinical symptoms and baseline parasites 28 days after the start of treatment, corrected by excluding new infections) was 97.4% for GanLum, compared to 94.0% with the standard of care. Under a conventional per protocol analysis, conducted post hoc, this represents a cure rate of 99.2%, compared to 96.7% with the standard of care.
• Uncorrected adequate clinical and parasitological response at Day 29 (proportion of patients free of clinical symptoms and any parasites 28 days after the start of treatment, regardless of whether a recurrence was due to recrudescence or new infection) was 85.3% for GanLum, compared to 82.1% for the standard of care.
• The safety profile was similar to standard of care and adverse events were generally consistent with the underlying disease.

About malaria 
Malaria is a life-threatening disease caused by a parasite and spread to humans by some types of mosquitoes. According to the most recent WHO data, there were 263 million cases of malaria and 597,000 deaths in 2023, almost all of them in Africa. Children under 5 years old accounted for about three in four malaria deaths in the region.⁵ 

About Novartis in malaria innovation 
Novartis has built the industry’s largest pipeline of treatments to control or eliminate malaria and neglected tropical diseases,⁶ backed by nearly USD 500 million in funding for global health R&D since 2021. This includes four new non-artemisinin antimalarial compounds with the potential to combat rising drug resistance. Novartis has delivered more than 1.1 billion treatment courses of its antimalarial Coartem since 1999, mostly at no profit, and earlier this year launched Coartem Baby, the first malaria treatment for newborns and young infants.

About MMV
MMV is a Swiss non-profit product development partnership. MMV works “end-to-end” to discover, develop and deliver affordable and accessible medicines to treat, prevent and eliminate malaria. Since 1999, over 1.3 billion people have benefited from MMV’s co-developed medicines. With malaria still killing 600,000 each year, MMV brings partners together to close the remaining gaps in antimalarial access and innovation.

For more information, visit www.mmv.org. Follow MMV on social media: X, LinkedIn, YouTube and Facebook 

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.

Reimagine medicine with us: Visit us at www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

1. Rosenthal, Philip J et al. The emergence of artemisinin partial resistance in Africa: how do we respond? The Lancet Infectious Diseases, Volume 24, Issue 9, e591 - e600.
2. Winnips, C., et al. KALUMA - A pivotal Phase III trial to evaluate the efficacy, safety and tolerability of the novel anti-malarial drug ganaplacide-lumefantrine (KLU156) in uncomplicated malaria, Presented at Annual Meeting of the American Society of Tropical Medicine and Hygiene, November 12, 2025.
3. LaMonte GM, et al. Pan-active imidazolopiperazine antimalarials target the Plasmodium falciparum intracellular secretory pathway. Nat Commun. 2020 Apr 14;11(1):1780; Brancucci NMB, et al. An all-in-one pipeline for the in vitro discovery and in vivo testing of Plasmodium falciparum malaria transmission blocking drugs. Nat Commun. 2025 Jul 25;16(1):6884; Gal IR, et al. Drug Interaction Studies of Cabamiquine:Ganaplacide Combination against Hepatic Plasmodium berghei. ACS Infect Dis. 2025 Jan 10;11(1):69-79.
4. Premji ZG. Coartem: the journey to the clinic. Malar J. 2009 Oct 12;8 Suppl 1(Suppl 1):S3.
5. WHO. Malaria.
6. Access to Medicine Foundation. Access to Medicine Index 2024.  

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