The U.S. Food and Drug Administration has approved a non-hormonal treatment for hot flashes. Lynkuet is a daily pill that relieves this common menopause symptom by manipulating the body’s internal thermostat.
The medication, which is known generically as elinzanetant, is produced by Bayer, and is the second drug of its kind to be greenlit by the FDA. It was cleared after three randomized clinical trials showed it significantly reduced the frequency and severity of hot flashes, which about 75 percent of women experience during the menopausal transition.
Hormone therapy is still considered the gold standard for treatment, but there’s long been a recognized need for more alternatives, as it’s not viable for everyone — particularly women with a history of breast cancer and certain cardiovascular conditions.
Here’s a closer look at how the drug works, its potential side effects, how much it’s expected to cost, and more.
How does Lynkuet prevent hot flashes?
The drug acts on specialized brain cells, called KNDy neurons, that regulate body temperature. There are two main types, NK1 and NK3, both of which have estrogen receptors and require the hormone to function properly.
When estrogen levels drop as we age, these neurons kick into overdrive in a bid to keep the internal thermostat working, which leads to hot flashes. Lynkuet and Veozah — another non-hormonal treatment cleared by the FDA in 2023 — work by binding to estrogen receptors on KNDy neurons. This fools the cells into thinking the body’s flush with estrogen and helps prevent hot flashes.
The major difference is that Lynkuet targets both NK1 and NK3 neurons, whereas Veozah targets only NK3 neurons.
In clinical trials, Lynkuet reduced hot flashes by 67 percent and also reduced sleep disturbances, writes Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s School of Medicine.
Does Lynkuet have any side effects?
Side effects include headache, fatigue, dizziness, feeling drowsy, and joint pain, Diana Bitner, MD, the chief medical officer of true. Women’s Health, tells us. There’s also some concern that, in rare cases, it may lead to liver damage, and the FDA is recommending liver function tests before patients start Lynkuet, the Washington Post reports.
Last year, the agency issued a warning for Veozah after a patient experienced elevated liver blood test values. However, in Lynkuet clinical trials, none of the participants experienced liver issues, though the FDA still recommends liver monitoring.
The pill shouldn’t be taken by pregnant women or people with a history of seizures, Dr. Bitner says.
How much is Lynkuet, and will it be covered by insurance?
Dr. Bitner says that she expects the medication to be “widely covered by most insurers.”
The wholesale cost is $625 a month, but insured patients “may pay as little as $25” monthly, Dr. Bitner says.
