Elinzanetant Becomes Newest Hormone-Free, Hot Flash Medicine to Receive FDA Approval
Updated on November 11, 2025
In October, the Food and Drug Administration approved the non-hormonal medicine elinzanetant (brand name: Lynkuet) for the treatment of hot flashes. The medicine — which is expected to be available in the U.S. beginning this month — offers a new hormone-free option for people seeking relief from a common symptom of hormonal therapy for breast cancer.
Unlike hormone replacement therapy (HRT), which is used to treat hot flashes and other symptoms of menopause, elinzanetant doesn’t contain estrogen or progesterone. This is important because HRT isn’t recommended for people with a history of breast cancer due to concerns that HRT can increase the risk of the cancer coming back (recurrence). HRT may also increase the risk of breast cancer in people who are at high risk of developing the disease.
Elinzanetant is also approved for use in Canada and the United Kingdom.
See elinzanetant prescribing information.
How elinzanetant works
Elinzanetant reduces hot flashes by blocking molecules in the nervous system called neurokinins. When estrogen levels drop, neurokinins tell the cells in your brain’s temperature control center to work overtime. This can cause hot flashes and night sweats (hot flashes that happen while you’re sleeping). Doctors call these vasomotor symptoms.
Elinzanetant blocks two neurokinins: neurokinin-1 and neurokinin-3. Veozah (chemical name: fezolinetant) — another hormone-free medication that was approved to treat post-menopausal hot flashes in 2023 — blocks neurokinin-3 only. Some researchers believe that because elinzanetant targets neurokinin-1 and -3, it may be less likely to cause serious liver problems linked to Veozah. Also, unlike elinzanetant, Veozah has not been studied in people with breast cancer receiving hormonal therapy.
What to expect with elinzanetant
Elinzanetant is a 60-mg capsule. You’ll take two capsules at bedtime, with or without food.
You should take the capsules whole and not cut, crush, or chew them.
Elinzanetant side effects
The most common side effects of elinzanetant include:
Elinzanetant may cause serious side effects, including seizures (in people with a history of seizures) and liver damage. Your doctor will do a blood test to check your liver before you start the medication and again three months after you start taking it. Stop taking elinzanetant and call your doctor if you experience:
nausea or vomiting
feeling more tired than usual
decreased appetite
itching
yellowing of the eyes or skin
pale poop
dark urine
stomach pain
Elinzanetant may cause pregnancy loss or stillbirth. Do not take elinzanetant if you’re pregnant or trying to become pregnant. There hasn’t been research on breastfeeding while taking elinzanetant, so talk to your doctor if you’re currently nursing.
Drug and food interactions
There are certain drugs and foods you should avoid while taking elinzanetant:
Strong CYP3A4 inhibitors may increase the amount of elinzanetant in your blood, increasing the risk of side effects. They include grapefruit and grapefruit juice, HIV medications such as ritonavir and saquinavir, and antibiotics like clarithromycin and ketoconazole.
Strong and moderate CYP3A4 inducers may reduce the amount of elinzanetant in your blood, making it less effective. They include phenytoin, prednisone, and St. John's wort.
If you’re on moderate CYP3A4 inhibitors, your doctor may recommend that you take one 60-mg capsule of elinzanetant instead of two.
Research on elinzanetant
A 2025 study of elinzanetant tested how well the medicine worked in women with a history of hormone receptor-positive breast cancer who were taking hormonal therapy.
The OASIS-4 study included 474 women who were taking either tamoxifen or an aromatase inhibitor and experiencing about 11 moderate-to-severe hot flashes a day. Two-thirds of the women took elinzanetant once a day for a year. The other third took a placebo — a pill that looked just like elinzanetant but contained no medicine — once a day for 12 weeks and then took elinzanetant once a day for the next 40 weeks.
After the first four weeks, women taking elinzanetant had six fewer hot flashes per day, and women taking the placebo had three fewer. After 12 weeks, women taking elinzanetant had eight fewer daily hot flashes, and women taking the placebo had four fewer.
Paying for elinzanetant
The cost of elinzanetant may vary. The price you’ll pay depends on your health insurance provider and plan, where you live, and the pharmacy you use.
Note: Your insurance company may require you to get prior authorization before covering elinzanetant.
If you have trouble paying for elinzanetant, ask your pharmacist or care team about financial assistance programs that may be able to help.
Learn more about financial assistance and medicine cost-lowering tips.