Drug Trials Snapshots: LYNKUET

LYNKUET (elinzanetant) lin-kew-ET Bayer Health Care Pharmaceuticals, Inc. Approval date: October 24, 2025 DRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms or VMS) due to menopause. How is this drug used? LYNKUET is taken as two capsules by mouth, with or without food, at about the same time each day at bedtime. For patients taking certain medicines, healthcare providers may reduce the dose to one capsule each day. Who participated in the clinical trials? The FDA approved LYNKUET based on evidence from three clinical studies (OASIS-1 [NCT05042362], OASIS-2 [NCT05099159], and OASIS-3 [NCT05030584]) involving 1,423 participants. Of these participants, 1,420 received treatment with either LYNKUET 120 mg or placebo during the studies. These trials were conducted at 267 clinical sites in 21 countries, with OASIS-1 taking place in 89 centers in nine countries (Austria, Czech Republic, Greece, Hungary, Israel, Italy, Netherlands, and the United States), OASIS-2 in 95 centers in 10 countries (Canada, Czech Republic, Germany, Italy, Norway, Poland, Portugal, Slovakia, Switzerland, and the United States), and OASIS-3 in 83 centers in nine countries (Belgium, Bulgaria, Canada, Denmark, Finland, Poland, Spain, the United Kingdom, and the United States). OASIS-1 and OASIS-2 were used to assess the efficacy of LYNKUET. OASIS-1, OASIS-2, and OASIS 3 were used to assess the safety of LYNKUET. Only OASIS-3 was placebo-controlled for the duration of 52 weeks. How were the trials designed? LYNKUET was only studied in females. There were 793 postmenopausal participants who received treatment in OASIS-1 and OASIS-2. There were 627 postmenopausal participants who received treatment in OASIS-3. The total number of postmenopausal participants receiving LYNKUET in the combined trials (OASIS-1, OASIS-2, and OASIS-3), which includes re-randomized participants previously receiving placebo in Trials 1 and 2, was 1,061. Efficacy and safety of LYNKUET were evaluated in two 26-week clinical trials (OASIS-1 and OASIS-2) of 796 participants who reported at least 50 moderate-to-severe hot flashes per week. In the first 12 weeks, these patients were randomized to LYNKUET 120 mg or placebo. After completing the first 12 weeks of treatment, placebo patients received LYNKUET 120 mg while LYNKUET patients continued their treatment for additional 14 weeks. In a separate 52-week long-term safety trial, 628 patients were randomized to LYNKUET 120 mg or placebo. DEMOGRAPHICS SNAPSHOT Figure 1 summarizes the percentage of females by their self-identified race who were enrolled in the combined clinical trials OASIS-1 and OASIS-2 used to evaluate the efficacy of LYNKUET. Figure 1. Baseline Demographics by Race, Efficacy Population Source: Adapted from FDA Review. * Other includes: Asian (4 participants; 0.5% of total), American Indian or Alaska Native (4 participants; 0.5% of total), multiple races (4 participants; 0.5% of total), and missing race information (8 participants; 1% of total). Figure 2 summarizes the percentage of females by their self-identified age who were enrolled in the combined clinical trials OASIS-1 and OASIS-2 used to evaluate the efficacy of LYNKUET. Figure 2. Baseline Demographics by Age, Efficacy Population Source: Adapted from FDA Review. Figure 3 summarizes the percentage of females by their self-identified ethnicity who were enrolled in the combined clinical trials OASIS-1 and OASIS-2 used to evaluate the efficacy of LYNKUET. Figure 3. Baseline Demographics by Ethnicity, Efficacy Population Source: Adapted from FDA Review. Figure 4 summarizes the percentage of females by their self-identified race who were enrolled in the combined clinical trials OASIS-1, OASIS-2, and OASIS-3 used to evaluate the safety of LYNKUET. Figure 4. Baseline Demographics by Race, Safety Population Source: Adapted from FDA Review. * Other includes: Asian (7 participants; 0.5% of total), American Indian or Alaska Native (4 participants; 0.3% of total), Native Hawaiian or other Pacific Islander (1 participant; 0.1% of total), multiple races (5 participants; 0.4% of total), and missing race information (42 participants; 4.4% of total). Figure 5 summarizes the percentage of females by their self-identified age who were enrolled in the combined clinical trials OASIS-1, OASIS-2, and OASIS-3 used to evaluate the safety of LYNKUET. Figure 5. Baseline Demographics by Age, Safety Population Source: Adapted from FDA Review. Figure 6 summarizes the percentage of females by their self-identified ethnicity who were enrolled in the combined clinical trials OASIS-1, OASIS-2, and OASIS-3 used to evaluate the safety of LYNKUET. Figure 6. Baseline Demographics by Ethnicity, Safety Population Source: Adapted from FDA Review. What are the benefits of this drug? LYNKUET reduces the frequency and severity of moderate to severe VMS in non-hysterectomized and hysterectomized postmenopausal females. Were there any differences in how well the drug worked in clinical trials among sex, race, and age? Sex: LYNKUET was only studied in healthy postmenopausal females Race: LYNKUET worked similarly in White and Black or African American participants. The number of patients of races other than White and Black or African American was small, therefore differences in how LYNKUET worked among races could not be determined. Age: Females 65 years of age and older were not included in LYNKUET clinical trials. What are the possible side effects? The safety of LYNKUET was evaluated in two 26-week clinical trials (OASIS-1 and OASIS-2) and in one 52-week clinical trial (OASIS-3). OASIS-1 and OASIS-2 were placebo-controlled for the first 12 weeks, after which participants previously receiving placebo were switched to LYNKUET 120 mg while participants previously randomized to LYNKUET 120 mg continued on treatment for an additional 14 weeks of uncontrolled treatment. OASIS-3 was a randomized, placebo-controlled, double-blind safety study evaluating the safety of LYNKUET 120 mg for 52 weeks. In the combined trials OASIS-1 and OASIS-2, commonly reported adverse reactions through the first 12 weeks included headache, fatigue, gastroesophageal reflux disease, dizziness, nausea, and somnolence. In OASIS-3, the most common adverse reactions included headache, fatigue, dizziness, somnolence, abdominal pain, rash, diarrhea, and muscle spasms. Were there any differences in side effects among sex, race, and age? Sex: LYNKUET was only studied in postmenopausal females. Race: The occurrence of side effects was similar in participants who self-identified as White and those who self-identified as Black or African American. The number of patients of races other than White and Black or African American was small, therefore differences in side effects among other races could not be determined. Age: Females 65 years of age and older were not included in LYNKUET clinical trials. GLOSSARY CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested. EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial. PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups. PRESCRIBING INFORMATION