The first new oral medication for Alzheimer’s cognitive symptoms in more than 20 years got FDA approval this summer. Zunveyl, a form of galantamine with far fewer side effects, will be in pharmacies by 2025.
While the world tracks the progress of disease-modifying Alzheimer’s anti-amyloids through the drug development and FDA approval pipeline, there are symptomatic treatments making their way through as well. While these aren’t designed to slow the actual underlying disease progression of Alzheimer’s through the brain, they are designed to improve quality of life by addressing its symptoms… and in one case — a drug approved by the FDA about two months ago, in late July — an existing drug for Alzheimer’s cognitive symptoms has been reworked to address one of the drug’s most difficult side effects.
Alpha Cognition’s pill Zunveyl is the first FDA-approved oral Alzheimer’s treatment in more than 20 years. It’s designed to treat cognitive symptoms in people with mild to moderate Alzheimer’s disease. The drug will be available in pharmacies starting in 2025.
What is Zunveyl?
Cholinesterase inhibitors (like Aricept and Razadyne) are prescribed to treat and help manage the cognitive symptoms of Alzheimer’s in the early and moderate stages of the disease. But, studies show that somewhere between two and three out of every five patients taking a cholinesterase inhibitor for Alzheimer’s symptoms eventually bail on their prescription because of uncomfortable gastrointestinal side effects like nausea, vomiting, and diarrhea.
Alzheimer’s Drugs 101: How Do Cholinesterase Inhibitors Work?
To address these issues, drugmaker Alpha Cognition has developed a new drug that is quite similar to a relatively well-known and previously FDA-approved cholinesterase inhibitor often prescribed for Alzheimer’s cognitive symptoms, galantamine. Zunveyl (previously called ALPHA-1062) is a version of galantamine that has been shown to have fewer side effects.
In July 2024, the FDA approved Zunveyl for people with mild to moderate Alzheimer’s, through the bioequivalence pathway (meaning the agency deems it just as effective as an existing drug).
“Zunveyl offers dual-action benefits with the established efficacy of galantamine and no insomnia. It was uniquely designed to bypass the gut with the potential of minimizing GI side effects,” Lauren D’Angelo, Alpha Cognition’s chief operating officer said in a press release. “We believe that Zunveyl’s unique combination of these attributes will make a meaningful difference in the lives of those affected by this debilitating disease.”
How does Zunveyl work for Alzheimer’s symptoms?
Zunveyl is designed as a precursor of the cholinesterase inhibitor drug galantamine, which is activated when it’s metabolized in the body.
But, this form of galantamine, called benzgalantamine, is a little different than the traditional drug. It is modified and packaged in a delayed-release capsule so that it doesn’t interact as much with the gut, which reduces unpleasant side effects like nausea, diarrhea, and vomiting. More of the drug is also able to get to the brain, which, according to the drugmaker, means that it is effective at treating cognitive symptoms for longer.
What is galantamine?
Galantamine is a drug formed from the extract of daffodil bulbs. It slows down the breakdown of a natural chemical signal within the brain called acetylcholinesterase, which is important for memory and cognitive functions. By slowing down the breakdown, galantamine promotes memory retention.
Galantamine is sold under the brand name Razadyne, as a generic drug, and also in supplement form. Researchers recently found that many brands of over-the-counter galantamine contain way less of the drug than advertised and some products are also contaminated with harmful bacteria.
There is some evidence that galantamine might also slow the disease process. Michael McFadden, CEO of Alpha Cognition, referenced a 2021 study that followed over 10,000 patients taking galantamine over ten years. Compared to other cholinesterase drugs, galantamine had a lower risk of death and the strongest effect on cognitive decline.
“It [galantamine] also demonstrated a significant reduction in risk of developing severe dementia compared to other cholinesterase inhibitors,” he said over email.
What are the side effects of Zunveyl, and how do they compare to traditional galantamine?
The company published the results of a 150-person study that found less than three percent of patients experienced nausea, vomiting, or diarrhea over seven days of taking Zunveyl. This is considerably lower than the frequency of side effects reported on the product label for galantamine — 38 percent experience nausea or vomiting, and nine percent experience diarrhea.
The drugmakers have shown that the formulation of Zunveyl reaches the same levels in the body as galantamine, so the company does not need additional clinical efficacy testing.
How much does Zunveyl cost?
According to McFadden, the anticipated out-of-pocket cost will be $30 to $50 per month. Medicare has not yet announced whether they will cover the drug.
What’s next for Alpha Cognition?
Alpha Cognition is also working on packaging Zunveyl into different formulations. McFadden said that the company is working on a dissolvable tablet for people with trouble swallowing, as well as a pill that combines Zunveyl and memantine for treating symptoms for people in moderate to severe stages of Alzheimer’s.