Some of the most common symptoms of menopause are vasomotor symptoms, also known as hot flashes and night sweats. Vasomotor symptoms can significantly affect sleep, daily activities, and overall quality of life. While hormone therapy has traditionally been used to manage vasomotor symptoms, not everyone can or wants to take hormone medicines.
In October 2025, the FDA approved Lynkuet (elinzanetant), a nonhormonal treatment for moderate to severe vasomotor symptoms due to menopause. Lynkuet was studied in postmenopausal women with frequent hot flashes that interfered with daily life. Unlike hormone therapy that replaces estrogen, Lynkuet works by targeting brain pathways involved in temperature regulation.
How Does Lynkuet Work?
Your temperature is controlled by a part of the brain called the hypothalamus. Inside the hypothalamus are special cells called KNDy (pronounced “candy”) neurons that help regulate heat. These neurons have NK1 and NK3 receptors that bind to substances that play a role in controlling your body temperature.
When estrogen levels fall, KNDy neurons become too active. Lynkuet works by blocking NK1 and NK3 receptors on these neurons. As these receptors are blocked, substances that play a role in controlling your body temperature cannot bind to them. Thus, Lynkuet may help reduce the frequency of hot flashes and night sweats.
How Do I Use Lynkuet?
Lynkuet is a capsule that you swallow. The usual dose is two capsules (120 mg total) once a day at bedtime. You can take Lynkuet with or without food, but you should always swallow the capsules with water.
How Was Lynkuet Studied?
Lynkuet was studied in two clinical trials called OASIS 1 and OASIS 2. These trials enrolled postmenopausal women aged 40-65 who were having at least 50 hot flashes per week.
A total of 796 women were randomly assigned to take either Lynkuet 120 mg once daily at bedtime or a placebo (containing no medicine) for 12 weeks. After that time, everyone in the trial received Lynkuet for another 14 weeks.
The average age of women in the trial was about 55, and 8.5% identified as Hispanic or Latino. Most women were White (80.4%). The rest included 17.1% Black or African American, 0.5% Asian, 0.5% American Indian or Alaska Native, 0.5% multiracial, and 1% who did not report race.
At the start of the study, women reported an average of 14.65 hot flashes per day. Women also rated the severity of their hot flashes, with an average severity score of 2.5. Severity scores range from 0 to 3, with 0 indicating no moderate or severe symptoms; 2 indicating moderate symptoms; and 3 indicating severe vasomotor symptoms.
The main goals of the studies were to see whether Lynkuet could reduce the frequency and severity of hot flashes compared to placebo.
What Are the Main Benefits Based on the Trials?
In both OASIS 1 and OASIS 2 trials, Lynkuet reduced the number and severity of hot flashes compared with placebo.
OASIS 1
- After four weeks: Women taking Lynkuet had about eight fewer hot flashes per day, compared with about four fewer in the placebo group.
- After 12 weeks: Women taking Lynkuet had about nine fewer hot flashes per day, compared with about six fewer with placebo.
The average amount of daily hot flashes at baseline and the average changes from baseline in the number of daily hot flashes at weeks 4 and 12 are shown in the table below.
Lynkuet | Placebo | |
|---|---|---|
| Baseline | 13.4 | 14.3 |
| Week 4 | -7.5 | -4.4 |
| Week 12 | -8.7 | -5.5 |
OASIS 2
- After four weeks: Women taking Lynkuet had about nine fewer hot flashes per day, compared with about six fewer in the placebo group.
- After 12 weeks: Women taking Lynkuet had 10 fewer hot flashes per day, compared with about seven fewer with placebo.
The average amount of daily hot flashes at baseline and the average changes from baseline in the number of daily hot flashes at weeks 4 and 12 are shown in the table below.
Lynkuet | Placebo | |
|---|---|---|
| Baseline | 14.7 | 16.2 |
| Week 4 | -8.6 | -6.1 |
| Week 12 | -10 | -7.2 |
The results of the OASIS 1 and 2 trials show that after week 4 and week 12 of treatment, women taking Lynkuet had about three fewer hot flashes per day compared to those taking placebo. In both trials, the reduction in the frequency of hot flashes began as early as one week after starting treatment. Lynkuet also improved the severity of hot flashes, making them feel less intense by week 4.
Your results may differ from what was seen in clinical studies.
What Can I Do to Manage Side Effects?
Lynkuet can cause drowsiness and other nervous system effects such as tiredness, dizziness, a spinning sensation (vertigo), or feeling faint. If you have any of these side effects, do not drive or operate machinery until they have completely gone away. Also, be careful if you need to get out of bed after taking Lynkuet. Rise slowly, sit on edge of bed for a minute, and hold onto something when you get up. Lynkuet should only be taken before bed. Try to take Lynkuet at about the same time each night.
Lynkuet may cause liver damage. Stop taking Lynkuet and get medical help right away if you have signs or symptoms of liver damage. These include decreased appetite, nausea, vomiting, itching, yellow skin, dark urine (pee), or lower stomach (abdominal) pain. Your health care provider will check your liver enzymes with a blood test before you start treatment with Lynkuet and again three months after you start taking the medicine. You may need to stop treatment with Lynkuet if your liver enzymes are too high during treatment.
What Types of Drug Interactions Can Happen?
Lynkuet can interact with many different medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using or have recently taken. This will help make sure your medicines work well together.
Your Lynkuet dose may be chosen based on other medicines that you take. Do not start or stop any medicine without talking with your health care provider.
Is There Any Cost Assistance Available?
Yes. There is a cost savings and support program offered by the drugmaker that may allow you to pay as little as $25 for your prescription. Your eligibility depends on what type of insurance you have. You can find out more information at https://www.lynkuet-us.com/cost-savings or by calling 866-839-0766.
