What to Know About Lynkuet, the New Hot Flash Drug

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<p>On October 24, 2025, the U.S. Food and Drug Administration (FDA)<a href="https://www.bayer.com/en/us/news-stories/lynkuet" target="_blank" rel="noreferrer noopener"> approved</a> Lynkuet (elinzanetant), a non-hormonal medication designed to reduce hot flashes and improve sleep in women going through menopause.</p>
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<p>Like<a href="https://medshadow.org/side-effects-of-veozah/" target="_blank" rel="noreferrer noopener"> Veozah</a>, another non-hormonal hot flash medication approved in 2023, Lynkuet acts on parts of the brain that control temperature and mood. Aside from these two drugs, doctors can also prescribe <a href="https://medshadow.org/hormone-therapy-misinformation-facts/" target="_blank" rel="noreferrer noopener">hormonal therapy</a> or <a href="https://medshadow.org/eal-people-ssris-side-effect-stories/" target="_blank" rel="noreferrer noopener">antidepressants</a> to help with hot flashes.</p>
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<p><a href="https://medvidi.com/team/dr-michael-chichak/" target="_blank" rel="noreferrer noopener">Michael Chichak</a>, M.D., a general practitioner with Medvidi, a telehealth platform providing mental health care in many states across the U.S., says the drug’s approval is an important step for women who can’t or don’t want to use hormonal therapies, “but, like with any new drug, we have to be careful. Most of the data we have is short term (around 6 months), so we don’t fully know how it performs over several years.”</p>
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<h2 class="wp-block-heading">What Do the Lynkuet Clinical Trials Show?</h2>
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<p>The approval was based on three trials, <a href="https://jamanetwork.com/journals/jama/fullarticle/2822766" target="_blank" rel="noreferrer noopener">OASIS 1, 2,</a> and 3, which included a total of 1,424 women.</p>
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<p>The longest of the three trials was <a href="https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2838538" target="_blank" rel="noreferrer noopener">OASIS 3,</a> which consisted of 628 women who took the drug or a placebo for up to one year. Although the number of participants is not large, it’s within range of a typical Phase 3 clinical trial, which <a href="https://medshadow.org/about-fda-drug-development-process-risk-of-side-effects/" target="_blank" rel="noreferrer noopener">usually includes</a> 300-3000 patients. </p>
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<p>OASIS 1 and 2 lasted 26 weeks.</p>
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<p>At the start of OASIS 3, participants reported experiencing an average of 6.7 to 6.8 moderate-to-severe hot flashes per day. After 12 weeks, women who were given the drug reported 1.3 per day. Women who received the placebo reported 3.3 per day. This reduction remained constant throughout the trials.</p>
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<p>“This was a randomized, double-blind study that showed significantly better results than a placebo in hundreds of patients over a period of up to a year, so it’s fairly robust data. I’d always like to see larger sample sizes, but this is fairly high quality,” says<a href="https://www.modernmenopause.ca/team/eileen-wang" target="_blank" rel="noreferrer noopener"> Eileen Wang</a>, M.D., M.S.C.P a doctor with Modern Menopause, a virtual menopause clinic in Canada, who has done advanced training in hormone therapy.</p>
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<h2 class="wp-block-heading">What Are The Side Effects of Lynkuet? </h2>
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<p>In OASIS 3, 70% of women who received Lynkuet and 61% of those who received the placebo reported at least one adverse event. These events led to 12.5% of women on Lynkuet and 4% on placebo dropping out of the trial. </p>
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<p>The most commonly reported adverse events were headaches, fatigue, and dizziness. One participant with a prior history of seizures experienced a seizure while taking Lynkuet. Because seizures were also observed in early animal studies, individuals with a history of seizures are advised to use the drug with caution.</p>
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<p>The researchers also closely tracked signs of liver damage, which were observed in 10 trial participants (six who got the drug and four who were given the placebo). Most cases resolved on their own, even with continued treatment with Lynkuet, and were not determined to be caused by the drug itself. However, it’s worth noting that seven months after Veozah — a hot flash medication approved in 2023 — entered the market, the FDA added <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216578s004lbl.pdf" target="_blank" rel="noreferrer noopener">a boxed warning</a> to its label following new reports of liver damage.</p>
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<p>Veozah works by targeting the neurokinin-3 receptor, while Lynkuet <a href="https://www.lynkuethcp.com/mechanism-of-action" target="_blank" rel="noreferrer noopener">acts on both the neurokinin-3 and neurokinin-1 receptors</a>. Both receptors are found throughout the brain and body, including the liver, which may help explain the potential for liver-related effects. As more people begin taking the drug, researchers may uncover additional side effects, possibly involving liver function.</p>
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<h2 class="wp-block-heading">Who Did the Lynkuet Trials Leave Out?</h2>
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<p>A close review of a clinical trial’s inclusion and exclusion criteria reveals not only who the drug was actually tested on, but also which groups were never evaluated. That matters, because both efficacy and side effects can vary across age, sex, race, and underlying medical conditions.</p>
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<p>The inclusion criteria for Lynkuet’s clinical trials limited participants to women ages 40–65 who were experiencing moderate to severe hot flashes. Hot flashes are considered moderate to severe when they cause both heat and sweating, or are strong enough to disrupt daily activities. Episodes that wake a person from sleep are classified as severe.</p>
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<p>The trial only included participants with a BMI between 18 and 38, excluding some people with Class II <a href="https://medshadow.org/obesity-definition/" target="_blank" rel="noreferrer noopener">obesity</a> and everyone with Class III obesity, the <a href="https://www.cdc.gov/bmi/adult-calculator/bmi-categories.html" target="_blank" rel="noreferrer noopener">highest level of the condition.</a> </p>
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<p>Of the women in the trials, about three-quarters identified as white and 12-19% identified as Black. In the first two trials, fewer than 10% identified as Hispanic or Latino; in the third trial, just over 10% did. The authors acknowledged in OASIS 3 that very few Asian, Native Hawaiian or Pacific Islander women participated in the trials.</p>
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<p>Because researchers want to understand the effects of the drug they’re testing, they often try to control for other variables by excluding people with certain conditions or those taking other medications they suspect might interfere with Lynkuet’s effects.</p>
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<p>In this case, the trials excluded anyone with the following conditions:</p>
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<li>Clinically significant prior or ongoing history of arrhythmias or other forms of irregular heart rates. </li>
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<li>Clinically significant abnormal laboratory screening test result</li>
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<li>Any active condition that may cause difficulty in interpreting hot flash symptoms</li>
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<li>Current or history (except complete remission for ≥5 years) of malignancy (except basal and squamous cell skin tumors)</li>
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<li>Uncontrolled or treatment-resistant hypertension</li>
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<li>Untreated hyperthyroidism or hypothyroidism</li>
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<li>Unexplained postmenopausal uterine bleeding</li>
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<li>Clinically relevant abnormal findings on a mammogram</li>
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<li>Renal impairment greater than moderate at screening</li>
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<li>Abnormal liver parameters</li>
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<li>Disordered proliferative endometrium, endometrial hyperplasia, polyp, or endometrial cancer diagnosed based on endometrial biopsy at screening</li>
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<p>They also excluded women who were taking the following medications:</p>
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<li>Hormonal therapies such as oral birth control pills, vaginal rings or creams, estrogen or progestin</li>
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<li>Clonidine</li>
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<li>Gabapentin</li>
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<li>Medical marijuana</li>
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<li>Drugs that act on CYP3A4. A large number of drugs and supplements, and even grapefruit juice, interact with this enzyme. Check your medications<a href="https://www.fda.gov/drugs/drug-interactions-labeling/healthcare-professionals-fdas-examples-drugs-interact-cyp-enzymes-and-transporter-systems#table%201" target="_blank" rel="noreferrer noopener"> here</a>.  </li>
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<p>Participants were allowed to continue taking the following medications provided that they were on a stable dose, and that the medications had been prescribed to manage conditions unrelated to hot flashes:</p>
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<li>Certain antidepressants, which are thought to impact hot flashes</li>
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<li>Over-the-counter or herbal remedies for menopause symptoms</li>
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<li>Oxybutynin, an overactive bladder medication</li>
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<p>If you fall into any of these groups or take any of these medications, it’s worth asking your healthcare provider what evidence exists, and what isn’t yet known, about how Lynkuet may affect you personally.</p>
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<p>Lynkuet may be a good option for women who can’t or don’t want to take hormonal therapies, says Dr. Chichack. “That said, it’s still not for everyone. If the hot flashes are mild or don’t happen often, lifestyle adjustments can still be the best first line of defense.” </p>
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<p>As of November 2025, Lynkuet is available with a prescription from your healthcare provider. </p>
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