Alzheimer’s disease agitation could mean peak sales of over $2.1 billion for Axsome’s Auvelity, according to analysts at William Blair.
The FDA has given the go-ahead to Axsome’s Auvelity for the treatment of agitation in patients with dementia associated with Alzheimer’s disease, marking the first non-antipsychotic drug to be cleared for this indication.
Axsome closed Thursday’s trading session up nearly 13%, hitting a share price of $207.75.
“We see Auvelity’s expansion into [Alzheimer’s disease agitation] as a large revenue opportunity,” analysts at William Blair wrote in a Thursday note to investors, estimating that peak sales could reach more than $2.1 billion in this indication for Axsome.
Auvelity combines two drugs: the NMDA receptor blocker dextromethorphan and the atypical antidepressant bupropion. The drug was first approved in August 2022 for major depressive disorder. Auvelity’s label carries a boxed warning for suicidal thoughts and behaviors.
The drug’s latest approval, announced Thursday, was based on the Phase 2/3 ADVANCE and Phase 3 ACCORD-2 studies.
Axsome reported mixed findings for Auvelity in Alzheimer’s agitation in January 2025. At the time, ACCORD-2 showed a 3.6-fold lower risk of relapse in patients on Auvelity versus placebo, meeting its primary endpoint. The study also hit a key secondary outcome, significantly improving the severity of agitation.
A second study, however, dubbed ADVANCE-2, found that Auvelity could not outperform placebo at easing agitation.
Still, Axsome decided to push through with a drug application, the company’s confidence boosted by two prior readouts that went in Auvelity’s favor. In November 2022, the Phase 3 ACCORD-1 trial showed that the drug significantly delayed the time to agitation relapse versus placebo, while in 2020, the Phase 2/3 ADVANCE-1 study demonstrated a significant improvement in agitation scores versus placebo.
With Thursday’s approval, Axsome will now face off against Otsuka and Lundbeck, which own Rexulti, the atypical antipsychotic that was first approved in 2015 for major depressive disorder. In 2023, the FDA cleared the drug for agitation in Alzheimer’s dementia, making it the first commercial therapy for the indication.
Lundbeck reported DKK 6.21 billion ($973 million) in 2025 sales for Rexulti, while Auvelity hit $507 million last year.
William Blair isn’t too worried about Auvelity, however, noting in its Thursday note that Lundbeck has only reached around 4.6% market share at the end of 2025, meaning that the indication “is wide open” for Axsome.
“There remains a major unmet need in [Alzheimer’s disease agitation] despite approval of Rexulti in the indication, given that Rexulti contains a black-box warning for mortality in elderly patients experiencing psychosis, which has high comorbidity overlap with agitation,” the analysts added.
