Last year, regulatory agencies in the U.S., Japan, China, and the U.K. all approved Eli Lilly’s new Alzheimer’s anti-amyloid drug Kisunla. Based on the status of drugs in the development pipeline, we don’t expect there to be another new Alzheimer’s drug in 2025. But, there are several promising drug candidates with Phase 3 trials wrapping this year and next. All are being tested to treat people with mild cognitive impairment or early Alzheimer’s disease. And unlike current treatments, most of these new treatment possibilities come in pill form — unlike their predecessors, they don’t need to be administered by infusion.
Here are some drugs to look out for in the news this year as they report results on ongoing trials. If these trials are ultimately successful, they may see regulatory approval in the next couple years.
Alzheon’s valiltramiprosate
Last year, Alzheon completed the 325-person Phase 3 trial of its disease-modifying pill valiltramiprosate, or ALZ-801. Rather than removing toxic plaques like anti-amyloid drugs, this pill prevents healthy forms of beta-amyloid from turning toxic. The drug is being tested as a treatment for people with two copies of the Alzheimer’s risk gene ApoE4. The company has not yet shared the trial’s results. Alzheon has not yet stated when they plan to file for approval in the U.S. and Europe.
AriBio’s AR1001
Across many large observational studies, scientists have found that people who take Viagra are less likely to develop Alzheimer’s. Some scientists think this may be due to the drug’s beneficial effects on blood vessels but a clinical trial is needed to know for sure whether the drug can treat Alzheimer’s. This year, AriBio will finish its 1,150-person Phase 3 trial testing its pill, AR1001, in early Alzheimer’s disease. AR1001 is already approved in South Korea for treating erectile dysfunction. The trial will finish at the end of 2025, and researchers may share preliminary results at Alzheimer’s conferences later this year.
Novo Nordisk’s semaglutide
Novo Nordisk’s diabetes drug, semaglutide (brand names Wegovy, Ozempic) is one of the most effective treatments for diabetes and weight loss. This type of drug — called a GLP-1 agonist — is designed to mimic the effect of a hormone in the body called GLP-1 that is involved in metabolism. Emerging evidence suggests they reduce the risk of many other conditions including heart attacks and stroke. In September, Novo Nordisk will wrap up its 1,840-person Phase 3 trial, which tested whether a semaglutide pill could treat the early stages of Alzheimer’s disease. The results may take some time to analyze, but researchers might share some of the data at Alzheimer’s conferences this year.
Eli Lilly’s remternetug
Remternetug is another anti-amyloid antibody drug for Alzheimer’s disease. Lilly is currently testing the drug in a 1,667-person Phase 3 trial. Previous anti-amyloid drugs required intravenous infusion. Lilly is concurrently testing an intravenous version of the drug alongside an injectable version, which uses a device similar to an EpiPen to deliver it under the skin. The trial will finish in early 2026, but the company might share a sneak peek of the data at conferences later this year.
