Elinzanetant (LYNKUET): A Bad Choice for Hot Flashes Due to Menopause

In October 2025 the Food and Drug Administration (FDA) approved elinzanetant (LYNKUET), an oral medication, for the treatment of moderate to severe vasomotor symptoms due to menopause.[1] Elinzanetant is a neurokinin 1 and neurokinin 3 receptor antagonist; it blocks two receptors in the brain that are thought to play a role in how body temperature is regulated.

Menopause is a normal stage in a woman’s life when the body’s production of the hormones estrogen and progesterone slows down and menstrual cycles permanently cease.[2] Some women experience postmenopausal symptoms such as hot flashes, mood swings and sleeping difficulty, as well as vaginal or vulvar atrophy. Hot flashes — also known as vasomotor symptoms — are a temporary sensation of heat, often with flushing and sweating, that can usually be managed with lifestyle-related strategies, such as keeping the core body temperature cool and exercising regularly.

If medication is needed for severe hot flashes, Public Citizen’s Health Research Group recommends using the lowest effective dose of menopausal hormone therapy for the shortest period — mainly estrogen-only therapy (such as conjugated estrogens [PREMARIN and generics]) for women without a uterus and combined estrogen and progestin (such as conjugated estrogens and medroxyprogesterone [PREMPHASE, PREMPRO]) for women with an intact uterus. Hormone therapy is effective at preventing hot flashes and treating vaginal or vulvar atrophy. Importantly, although the FDA recently approved labeling changes, concerns about the safety of hormone replacement therapy remain.

Unlike menopausal hormone therapy, elinzanetant is approved only for the treatment of hot flashes, not other menopause symptoms.[3]

Elinzanetant, taken as two 60-milligram (mg) capsules once a day, is similar to fezolinetant (VEOZAH), a neurokinin 3 receptor antagonist that the FDA approved for the same indication in 2023.[4] Public Citizen’s Health Research Group designated fezolinetant as a Do Not Use drug based on safety concerns and its limited benefits. When fezolinetant was approved, the prescribing information included a general warning about elevated levels of a liver enzyme known as hepatic transaminase, similar to the warning in the prescribing information of elinzanetant discussed below.[5] A few months after approving fezolinetant, the FDA issued a safety warning.[6] Subsequently, the FDA added a boxed warning — the agency’s most prominent warning — after a post-marketing case showed that the drug can cause rare but serious liver injury.[7]

Because elinzanetant is a new drug, its long-term effects on the liver have not yet been established. Based on the marginal benefits and concerns about its long-term safety, Public Citizen’s Health Research Group has also designated elinzanetant as a Do Not Use drug.

Efficacy of elinzanetant

The efficacy of elinzanetant was assessed in two short-term industry-funded, double-blind trials with similar research designs.[8],[9] A total of 796 postmenopausal women with an average age of 55 years were randomized to receive either 120 mg of elinzanetant for 26 weeks once daily or placebo for the first 12 weeks followed by the same dose of elinzanetant for the remaining 14 weeks of the trials.

Before the trials, the participants (who had to have a minimum of at least 50 moderate to severe hot flashes per week) experienced an average of 13.4 to 16.2 hot flashes per day. This number of hot flashes is substantially more than most postmenopausal women typically experience. One in four postmenopausal women report having daily hot flashes[10]; women experiencing hot flashes report an average of four to five per day.[11]

In one of the trials, the frequency of daily hot flashes in the elinzanetant-treated group decreased by 7.6 and 8.7 hot flashes per day after four weeks and 12 weeks, respectively. Participants in the placebo group had 4.3 and 5.4 fewer hot flashes at four weeks and 12 weeks, respectively.[12] Although statistically significant, the difference between the two groups was only 3.3 daily hot flashes at four weeks and 3.2 at 12 weeks. The difference between the groups in hot-flash severity, measured on a range from 0 to 3, was also significant but marginal, 0.3 and 0.4 at weeks four and 12, respectively. The other trial had similar results. In both trials, elinzanetant showed marginal but statistically significant improvements in menopause-related quality of life and sleep quality.[13]

In a third industry-funded, double-blind trial conducted over 52 weeks, 628 postmenopausal women (average age 55 years) were randomized to receive 120 mg of elinzanetant or a placebo once daily.[14] At the beginning of the trial, the participants had an average of about seven hot flashes per day, slightly higher than for postmenopausal women overall. Importantly, in this study the difference between groups in the reduction of hot-flash frequency at 12 weeks was only 1.6, a difference that may not be clinically meaningful for patients despite being statistically significant.[15]

Safety of elinzanetant

The most frequently reported adverse events include headache, fatigue, dizziness, somnolence, abdominal pain, rashes, diarrhea and muscle spasms.[16] In the 52-week trial, serious treatment-related adverse events were more common in the elinzanetant group (4.2%) than in the placebo group (1.9%).

The prescribing information for elinzanetant includes a general warning about the effects on the nervous system, including somnolence, fatigue, feeling faint, vertigo and dizziness. Across all three trials, these adverse events were more common in participants receiving elinzanetant (11.9%) than for those receiving placebo (3.5%). Moreover, in a small study assessing driving performance that included 64 healthy women, some participants were impaired. Some people should not drive or engage in potentially hazardous activities when taking elinzanetant.

The prescribing information also warns about elevated hepatic transaminase levels. Prior to starting the medication, and after three months of treatment, patients should have blood tests to evaluate their liver function. If liver enzyme levels are too high, the drug should either be stopped or not started.

Elinzanetant should not be taken during pregnancy, as it can cause pregnancy loss or stillbirth. Additionally, the drug may increase the risk of photosensitivity or seizures in people with a history of seizures.

Although there are no clinical trials directly comparing elinzanetant with fezolinetant,[17] two recent systematic reviews assessed studies that indirectly compared either fezolinetant or elinzanetant with placebo for vasomotor symptoms in postmenopausal women. Both reviews found that elinzanetant had a slightly greater effect than fezolinetant. The safety findings differed, with elinzanetant showing an increased risk of adverse events in one review[18] and a better safety profile than fezolinetant in the other.[19] Moreover, there are no clinical trials comparing either elinzanetant or fezolinetant with hormone replacement therapy for hot flashes. It is not known whether hormone therapy or the other drugs are more effective.

What You Can Do

Public Citizen’s Health Research Group recommends that you do not use elinzanetant for hot flashes due to menopause. If you experience hot flashes, first try lifestyle-related strategies, such as lowering room temperature, dressing in layers, drinking cold water and avoiding certain foods and drinks (such as coffee and alcoholic beverages).

If nondrug approaches fail and your hot flashes are severe enough to prevent you from working or carrying out other important activities, discuss with your clinician whether hormone replacement therapy is an option. Hormone replacement therapy can have severe adverse effects; in some situations, such as if you have had breast cancer, it should not be used. Menopausal hormone therapy should be used at the lowest dose and for the shortest duration possible to relieve symptoms.
 

References

[1] Bayer HealthCare Pharmaceuticals Inc. Label: elinzanetant (LYNKUET). October 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf. Accessed March 8, 2026.

[2] Do not use fezolinetant (VEOZAH) for the treatment of hot flashes (vasomotor symptoms). Worst Pills, Best Pills News. May 2024. https://www.worstpills.org/newsletters/view/1595. Accessed March 8, 2026.

[3] Bayer HealthCare Pharmaceuticals Inc. Label: elinzanetant (LYNKUET). October 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf. Accessed March 8, 2026.

[4] Do not use fezolinetant (VEOZAH) for the treatment of hot flashes (vasomotor symptoms). Worst Pills, Best Pills News. May 2024. https://www.worstpills.org/newsletters/view/1595. Accessed March 8, 2026.

[5] Astellas Pharma US. Label: fezolinetant (VEOZAH). December 2024. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s004lbl.pdf. Accessed March 9, 2026.

[6] E-Alert: FDA issues warning about rare but serious liver injury with the use of fezolinetant (Veozah) for hot flashes due to menopause. September 16, 2024. https://www.worstpills.org/e-alerts/view/146. Accessed March 8, 2026.

[7] News Brief: FDA’s new boxed warning for the hot-flash drug fezolinetant (VEOZAH) confirms do not use designation. Worst Pills, Best Pills News. April 2025. https://www.worstpills.org/newsletters/view/1657. Accessed March 8, 2026.

[8] Food and Drug Administration. Integrated review: LYNKUET, NDA 219469. October 24, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/219469Orig1s000IntegratedR.pdf . Accessed March 8, 2026.

[9] Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354.

[10] Williams RE, Kalilani L, DiBenedetti DB, et al. Frequency and severity of vasomotor symptoms among peri-and postmenopausal women in the United States. Climacteric. 2008;11(1):32-43.

[11] Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: A phase 3 randomized clinical trial. JAMA Intern Med. 2025;185(11):1319-1327.

[12] Bayer HealthCare Pharmaceuticals Inc. Label: elinzanetant (LYNKUET). October 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf. Accessed March 8, 2026.

[13] Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354.

[14] Panay N, Joffe H, Maki PM, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: A phase 3 randomized clinical trial. JAMA Intern Med. 2025;185(11):1319-1327.

[15] Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354.

[16] Bayer HealthCare Pharmaceuticals Inc. Label: elinzanetant (LYNKUET). October 2025. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf. Accessed March 8, 2026.

[17] Elinzanetant (Lynkuet) for menopausal vasomotor symptoms. Med Lett Drugs Ther. 2025;67(1744):203-206.

[18] Menegaz de Almeida A, Oliveira P, Lopes L, et al. Fezolinetant and elinzanetant therapy for menopausal women experiencing vasomotor symptoms: A systematic review and meta-analysis. Obstet Gynecol. 2025;145(3):253-261.

[19] de Oliveira HM, Diaz CAV, Barbosa LM, et al. Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis. Maturitas. 2025;195(April):108220.