A new drug, AXS 05 is showing promise as a safer, non antipsychotic treatment for ‘agitation’ in Alzheimer’s disease, offering new hope for patients and caregivers alike.

At the recent 2025 American Academy of Neurology annual meeting, Axsome Therapeutics shared promising results for AXS 05, a combination of bupropion and dextromethorphan, as a potential treatment for agitation in people with Alzheimer’s disease. Unlike current options, AXS 05 is not an antipsychotic and has shown a better safety profile. This makes it a strong candidate to improve how agitation in Alzheimer’s is treated.

Agitation is a common and very distressing symptom in people with Alzheimer’s. It often leads doctors to prescribe antipsychotics or sedatives, even though these are not approved for this purpose. These drugs can carry serious risks, especially for older adults. At present, only one drug called Rexulti, which contains brexpiprazole, has been approved by the FDA to treat agitation in Alzheimer’s patients. However, experts believe its effectiveness is similar to other antipsychotics and does not represent a breakthrough.

According to GlobalData’s report, this is where AXS 05 could make a real difference. It has a unique, non-antipsychotic mechanism of action and was well tolerated in clinical trials, including the ACCORD 2 study. Doctors are also already familiar with AXS 05 because it is used to treat major depressive disorder. This familiarity could make it easier for them to prescribe the drug for Alzheimer’s agitation if it receives approval.

A significant unmet need in the Alzheimer’s disease market is finding better treatments for behavioural symptoms, especially agitation, said experts from GlobalData. Agitation is not only difficult for patients but also emotionally draining for caregivers. The options currently available are limited and not always safe.

She added that many doctors and key opinion leaders interviewed by GlobalData believe AXS 05, if approved, could offer a needed non-antipsychotic option for managing agitation. Its strong safety profile and encouraging clinical results set it apart.

According to GlobalData’s report titled Alzheimer’s Disease in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2033, AXS 05 is projected to reach around 307.3 million dollars in United States sales by the year 2033. This highlights the strong potential of the drug to become a major player in the market.

AXS 05 will face competition from other innovative drugs in development, such as masupirdine from Suven Life Sciences and Igalmi, which contains dexmedetomidine, from BioXcel Therapeutics. However, since both Axsome and BioXcel are currently focusing only on the US market, there is still plenty of opportunity for companies to expand into international markets where agitation in Alzheimer’s remains under treatment.

With a growing need for safer and more targeted treatments, AXS-05 could mark a significant step forward in improving the quality of life for both Alzheimer’s patients and their caregivers.