A Combined Single- and Multiple-dose, Open-label, Randomized, 2 x 2 Crossover Study to Investigate the Relative Bioavailability of Two Oral Elinzanetant (BAY 3427080) Formulations in Healthy Female Participants

This study is being done to compare two forms of the medicine elinzanetant, which is used to help manage hot flush symptoms related to changes in female hormones. The researchers want to find out whether a new tablet form of elinzanetant is absorbed and processed by the body of healthy women in a similar way than an existing capsule form.
About 100 healthy women aged 18 to 65 will take part in this study. Each participant will receive both forms of the medicine at different times during the study. They will take the medicine once daily for several days under controlled conditions at a study center, and blood samples will be collected to measure how the body absorbs and handles the drug. The study is designed so that each participant can be compared to herself, helping researchers clearly understand any differences between the two formulations.

Start Date22 Jul 2026

Sponsor / Collaborator

Bayer AG

NCT07077395

/ RecruitingPhase 2IIT

Finding Links Between Hot flASHes and CardioVascular Disease

The goal of this clinical trial is to learn if neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improves blood vessel health in women with moderate to severe hot flashes. The main questions it aims to answer is does neurokinin-1/neurokinin-3 receptor antagonist elinzanetant improve blood vessel health?

Start Date01 Mar 2026

Sponsor / Collaborator

The Massachusetts General Hospital

100 Clinical Results associated with Elinzanetant

100 Translational Medicine associated with Elinzanetant

100 Patents (Medical) associated with Elinzanetant

Literatures (Medical) associated with Elinzanetant

13 Oct 2026·SLEEP

Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study

Article

Author: Nappi, Rossella E ; Baker, Fiona C ; Joffe, Hadine ; Krahn, Ulrike ; Kramer, Frank ; Radcliffe, Hoi-Shen ; Soares, Claudio N ; Bajbouj, Malek ; Caetano, Cecilia ; Maki, Pauline M ; Zammit, Gary ; Seitz, Christian ; Shalhoub, Huda

Abstract:

Study Objectives:

Menopausal sleep disturbances can negatively impact quality of life. Elinzanetant, a dual neurokinin (NK)-1/NK-3 receptor antagonist, reduced self-reported sleep disturbance in postmenopausal women with moderate-to-severe vasomotor symptoms (VMS) in Phase III OASIS trials. NIRVANA explored elinzanetant’s effect on multimodal measures of objective and subjective sleep disturbance in postmenopausal women.

Materials and Methods:

Postmenopausal women (N = 110; 40–65 years) with moderate-to-severe VMS (≥20/week) and sleep disturbance (polysomnography [PSG] wakefulness after sleep onset [WASO] ≥30 min) were randomized 1:1 to receive elinzanetant 120 mg or placebo for 12 weeks. Sleep disturbance was assessed using PSG; daily Sleep Diary; and nightly contactless home-monitoring (Sleepiz One+ subgroup). The effect of elinzanetant versus placebo was analyzed using mixed-model repeated measures.

Results:

Elinzanetant was estimated to reduce PSG WASO at Week 4 versus placebo (least square [LS]-mean difference = –22.50 minutes, 90% CI: –35.47, –9.52). Minimal group differences between treatment arms were estimated at Week 12 for PSG WASO (LS-mean difference = –0.94 minutes, 90% CI: –13.96, 12.09). When including all available PSG data across the 12-week period, post hoc random coefficient modeling indicated treatment effects favoring elinzanetant for WASO, total sleep time, sleep efficiency, latency to persistent sleep, number of awakenings, arousal index, and % Stage N2 sleep. Treatment effects on WASO and awakenings favoring elinzanetant were observed with Sleepiz One+ and Sleep Diary across 12 weeks.

Conclusion:

In this sleep-focused study, elinzanetant reduced WASO at Week 4 and led to estimated improvements in sleep continuity over 12 weeks, supported by multimodal subjective and objective sleep outcomes.

13 Oct 2026·SLEEP

Elinzanetant improves sleep in postmenopausal women. So does placebo

Article

Author: Perrault, Aurore A ; Gordon, Christopher J ; Lappin, Julia M

01 Oct 2026·ANNALS OF PHARMACOTHERAPY

Elinzanetant: A Novel Approach to Management of Vasomotor Menopausal Symptoms

Review

Author: Barnes, Kylie N. ; Rowe, Jordan M. ; Coffman, Ian

Objective::

To review the efficacy and safety of elinzanetant for the management of vasomotor symptoms (VMS) associated with menopause.

Data Sources::

Literature was identified using PubMed (1966 to January 2026), EMBASE (1973 to January 2026), and clinicaltrials.gov. Search terms included elinzanetant, VMS, and menopause, limiting trials to those published in English.

Study Selection and Data Extraction::

Articles selected for inclusion included trials evaluating elinzanetant for the treatment of VMS.

Data Synthesis::

Elinzanetant was evaluated for reduction in frequency and severity of moderate-to-severe VMS associated with menopause in 3 phase 3 trials (OASIS 1, 2, and 3) and 1 phase 3 trial in patients receiving endocrine therapy for breast cancer (OASIS 4). All studies showed significant improvements in symptom frequency at week 12 compared to placebo ( P < .001). Improvement in sleep disturbances and quality of life was also significant in OASIS 1, 2, and 4. Elinzanetant was well-tolerated, with headache, fatigue, dizziness, somnolence, abdominal pain, and rash reported as the most frequent drug-associated adverse effects.

Relevance to Patient Care and Clinical Practice in Comparison to Existing Drugs::

Elinzanetant is the first dual neurokinin-1 and neurokinin-3 receptor antagonist approved for moderate-to-severe VMS associated with menopause. Elinzanetant offers a nonhormonal treatment option with favorable tolerability, representing a promising alternative for patients who cannot or prefer not to use hormonal therapy.

Conclusion::

The U.S. Food and Drug Administration approval of elinzanetant provides an additional nonhormonal option for managing moderate-to-severe VMS of menopause in patients for whom hormonal therapy is contraindicated or undesired.

118

News (Medical) associated with Elinzanetant

26 Oct 2026

·www.biospace.com

Bayer Shares New Post Hoc Analysis Of Self-Reported Sleep-Related Outcomes with Lynkuet® (elinzanetant) in Women with Moderate to Severe Vasomotor Symptoms at the Menopause Society Annual Meeting

Lynkuet ® (elinzanetant) 60 mg capsules is a neurokinin 1 (NK1) receptor and NK3 receptor antagonist FDA-approved for the treatment of moderate to severe vasomotor symptoms (VMS), also known as hot flashes, due to menopause, based on data from the pivotal Phase III safety and efficacy trials, OASIS-1 and -2 and the long-term safety trial OASIS-3. A pooled post hoc analysis of Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), a key secondary endpoint of the Phase III OASIS-1 and OASIS-2 trials, evaluated various aspects of sleep disturbance among patients receiving Lynkuet ® compared with placebo in women with moderate to severe VMS due to menopause. WHIPPANY, N.J.--(BUSINESS WIRE)--Bayer announced a new post hoc sub-analysis of key secondary endpoint data from the OASIS-1 and OASIS-2 pivotal trials for Lynkuet ® (elinzanetant) 60mg capsules at 2026 The Menopause Society (TMS) Annual Meeting. In this sub-analysis, data from one of the key secondary endpoints, Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF 8b), was analyzed to further evaluate the effect of Lynkuet on sleep disturbance in women with moderate to severe vasomotor symptoms (VMS). The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS-1 and OASIS-2, in 796 menopausal women. 1 The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12. 1 The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. 1 In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety. Lynkuet is contraindicated in women who are pregnant. Lynkuet can cause serious side effects including central nervous system depressant effects and daytime impairment, hepatic transaminase elevations, risk of pregnancy loss, and risk of seizure. The most frequently reported (≥5%) adverse reactions and greater than placebo in the OASIS-3 long term safety trial were headache, fatigue, dizziness and somnolence. “Sleep disturbances due to vasomotor symptoms are among one of the most frequent symptoms experienced by women with menopause,” said Kristie Baisden, DO, Vice President, U.S. Medical Affairs, Women’s Health at Bayer. “These findings add to the growing body of evidence related to sleep impacts due to vasomotor symptoms and expand our understanding of Lynkuet and VMS related sleep-related outcomes.” Effect of Lynkuet on Self-Reported Sleep Disturbance in the OASIS-1 and OASIS-2 Trials In the post hoc exploratory sub-analysis, responses were evaluated across eight items of the PROMIS SD SF 8b questionnaire using pooled data from OASIS-1 and OASIS-2. The mean change in the PROMIS SD SF 8b total T-score from baseline to Week 12 was a key secondary endpoint in the OASIS-1 and OASIS-2 trials. PROMIS SD SF 8b is an 8-item instrument evaluating self-reported sleep disturbance over a 7-day recall period using a 5-point Likert scale with higher numbers indicating higher levels of sleep disturbances. The eight items include restless sleep, satisfaction with sleep, refreshing sleep, difficulties falling asleep, staying asleep, getting to sleep, amount of sleep, and sleep quality. 2 Raw scores from each of the eight individual PROMIS SD SF 8b subdomains were analyzed descriptively over time to characterize the specific dimensions of sleep disturbance that were reduced by Lynkuet compared with placebo. At baseline, PROMIS raw item scores were mostly comparable between participants in the Lynkuet and placebo groups. By Week 12, a greater proportion of women reported decreased raw scores across all 8 items with Lynkuet vs placebo. For example, the proportion of women reporting poor/very poor sleep quality decreased more with Lynkuet (66.6% at baseline vs 20.5% at week 12) than placebo (57.8% at baseline vs 38.7% at week 12). The findings were presented during a poster presentation at the 2026 TMS Annual Meeting. Results were obtained from participants in the OASIS-1 and 2 phase III clinical trials who met specific inclusion and exclusion criteria; therefore, results may not be generalizable to the broader population of patients seen in clinical practice. In addition, outcomes were based on patient-reported measures, which are subject to individual interpretation and potential reporting bias. The individual items were analyzed descriptively in a post hoc exploratory analysis and lacked formal statistical hypothesis testing to assess differences between groups. Product Indication and Important Safety Information INDICATION LYNKUET ® (elinzanetant) is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. IMPORTANT SAFETY INFORMATION Contraindications: LYNKUET is contraindicated in pregnancy. Exposure to LYNKUET may cause pregnancy loss or stillbirth when administered during pregnancy. Warnings and Precautions: Central Nervous System Depressant Effect and Daytime Impairment: In the three OASIS trials, nervous system effects (including somnolence, fatigue, vertigo, dizziness and presyncope) occurred in 11.9% of patients on LYNKUET compared to 3.5% on placebo. Advise patients about the potential for somnolence and other nervous system effects. Advise patients who experience these effects to refrain from driving or engaging in hazardous occupations or activities until the effects have resolved. Hepatic Transaminase Elevations: Elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] concentrations equal to or greater than three times the upper limit of normal (ULN) occurred in 0.6% of patients receiving LYNKUET and 0.4% of patients receiving placebo up to 12 weeks in three clinical trials. Perform baseline bloodwork (including ALT, AST, alkaline phosphatase, and total and direct bilirubin) prior to initiation of LYNKUET to evaluate for hepatic function and injury. Do not start therapy if serum transaminase concentration is equal to or exceeds two times the ULN or if the total bilirubin is equal to or exceeds two times the ULN. Perform follow-up evaluations of hepatic transaminase concentration 3 months after initiation of therapy. Advise patients to discontinue LYNKUET immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain). Discontinue LYNKUET if transaminase elevations exceed five times the ULN or if transaminase elevations exceed three times the ULN and total bilirubin exceeds two times the ULN. Risk of Pregnancy Loss: LYNKUET is contraindicated for use in pregnancy. Findings from animal studies suggest that LYNKUET can cause pregnancy loss or stillbirth. Exclude pregnancy in females of reproductive potential prior to initiating LYNKUET. Advise females of reproductive potential to use effective contraception during treatment with LYNKUET and for 2 weeks after stopping LYNKUET. Risk of Seizure: Seizure was reported in patients taking LYNKUET. In addition, convulsions were observed in studies conducted in male and female rats. Advise patients about the potential risk of seizure. Use LYNKUET with caution in patients with a history of seizures or with conditions that potentially lower the seizure threshold. Most Common Adverse Reactions: The most frequently reported (≥5%) adverse reactions with LYNKUET vs placebo in a 52-week study were: headache (9.6% vs 7.0%), fatigue (7.3% vs 2.9%), dizziness (6.1% vs 1.9%) and somnolence (5.1% vs 1.3%). Drug Interactions: Effects of Other Drugs on LYNKUET Strong CYP3A4 Inhibitors and Grapefruit (Juice): Concomitant use of LYNKUET with strong CYP3A4 inhibitors and grapefruit (juice) should be avoided as it may increase the risk of LYNKUET-associated adverse reactions. Moderate CYP3A4 Inhibitors: Reduce LYNKUET dose if administered concomitantly with moderate CYP3A4 inhibitors as it may increase the risk of LYNKUET-associated adverse reactions. Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of LYNKUET with strong and moderate CYP3A4 inducers. Effects of LYNKUET on Other Drugs CYP3A4 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A4 substrates where minimal concentration changes may lead to serious adverse reactions, as it may increase the risk of adverse reactions related to these substrates. Use in Specific Populations: Pregnancy LYNKUET is contraindicated in pregnancy. If pregnancy occurs during the use of LYNKUET, discontinue treatment. Hepatic Impairment LYNKUET is not recommended in patients with moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment. Renal Impairment The effect of end-stage renal disease (eGFR <15 mL/min), with or without hemodialysis, on the pharmacokinetics of LYNKUET has not been studied. For important information about LYNKUET, please see Full Prescribing Information. About Lynkuet ® (elinzanetant) Lynkuet ® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate to severe hot flashes due to menopause. About the OASIS-1, 2 and 3 trials The FDA approval of Lynkuet ® (elinzanetant) 60mg capsules is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS-1 and OASIS-2, in 796 menopausal women. The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Find more information at Follow us on LinkedIn: Bayer | Pharmaceuticals: Overview | LinkedIn Follow us on Facebook: Follow us on X: @BayerUS Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References LYNKUET ® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026. Yu L, et al. Behav Sleep Med 2011;10(1):6–24. Contacts Media Contact: Polina Miklush polina.miklush@bayer.com +1-862-431-8817

Clinical ResultPhase 3Drug Approval

28 Sep 2026

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U.S. FDA Accepts sNDA and Grants Priority Review to Bayer’s Lynkuet® (elinzanetant) for a New Indication for the Treatment of Moderate to Severe Vasomotor Symptoms Due to Endocrine Therapy Related to Breast Cancer

Bayer’s supplemental New Drug Application (sNDA) is based on results from the Phase III OASIS-4 investigational study for the treatment of moderate to severe vasomotor symptoms in women receiving endocrine therapy for the treatment or prevention of breast cancer. 1 Lynkuet ® (elinzanetant) 60mg capsules was approved by the U.S. Food and Drug Administration (FDA) in October 2025 for the treatment of moderate to severe hot flashes due to menopause. 2 WHIPPANY, N.J.--(BUSINESS WIRE)--Today Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental New Drug Application (sNDA) and granted Priority Review designation for Lynkuet ® (elinzanetant) under investigation for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) in women receiving endocrine therapy for treatment of breast cancer. First approved by the FDA in October 2025 for the treatment of moderate to severe VMS due to menopause, Lynkuet is a dual neurokinin (NK) targeted therapy, neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist. 2 “Currently, there are no FDA approved treatment options for moderate to severe vasomotor symptoms associated with endocrine therapy in patients with HR+ breast cancer in the U.S. This treatment gap underscores an important unmet medical need for this population,” said Kristie Baisden, DO, Vice President, U.S. Medical Affairs, Women’s Health at Bayer. “As a global leader in women’s healthcare, this priority review is an important milestone for Bayer and underscores our commitment to women’s health and making treatment options available. We look forward to working closely with the Agency as they review the application.” The sNDA for Lynkuet is based on results of the Phase III OASIS-4 trial. Key details and findings from the study include: The OASIS-4 study was a 52-week, double-blind, randomized placebo-controlled Phase III interventional study conducted at 90 sites outside of the U.S. A total of 474 women 18 to 70 years of age with moderate to severe VMS associated with endocrine therapy for HR+ breast cancer or its prevention were randomized 2:1 to elinzanetant (n=316) for 52 weeks or placebo for 12 weeks, followed by elinzanetant for 40 weeks (n=158). 1 Lynkuet met the primary endpoints of reducing the mean daily frequency of moderate to severe VMS symptoms from baseline to week 4 and 12 compared to placebo, in women receiving endocrine therapy for treatment or prevention of HR+ breast cancer. 1 Common adverse events during the trial were headache, fatigue, and somnolence. During the placebo controlled period of the study for the first 12 weeks, somnolence, fatigue, and diarrhea were reported more frequently with elinzanetant than with placebo. 1 The key findings were presented at ASCO 2025 and simultaneously published in the New England Journal of Medicine (NEJM) in June 2025. In the U.S., breast cancer accounts for 30% of all cancers in women, with HR+ cancers comprising approximately 70% of all breast cancer cases. 3 HR+ breast cancer treatment guidelines from the American Society of Clinical Oncology recommend endocrine therapy, with a minimum duration of use of 5 years, with potential extension to 10 years based on cancer type and other clinical considerations. 4 Hot flashes can be a common side effect of endocrine therapy treatment. 1 “Endocrine therapy is a standard of care for many women facing HR+ breast cancer and can commonly cause side effects such as vasomotor symptoms,” said OASIS-4 Primary Investigator Fatima Cardoso, MD, FESMO Director Breast Unit, Centre Antoine Lacassagne and Advanced Breast Cancer (ABC) Global Alliance, Nice, France. “It’s important that we continue to learn more about vasomotor symptoms due to endocrine therapy as part of supporting women throughout their breast cancer care journey.” The October 2025 FDA approval was supported by data from three Phase III clinical trials (OASIS-1, OASIS-2 and OASIS-3) evaluating the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. 2,5,6 Product Indication and Important Safety Information INDICATION What is LYNKUET ® (elinzanetant)? LYNKUET is a prescription medicine used to reduce moderate to severe hot flashes (also known as vasomotor symptoms) due to menopause. LYNKUET is not a hormone. Hot flashes are feelings of warmth in the face, neck, and chest, or sudden intense feelings of heat and sweating. IMPORTANT SAFETY INFORMATION Do not take LYNKUET if you: are pregnant Before you use LYNKUET, tell your healthcare provider about all of your medical conditions, including if you: have liver problems have a history of seizures or have a condition that may increase your risk of having a seizure are pregnant or planning to become pregnant. LYNKUET may harm your unborn baby. Women who can become pregnant should talk to their healthcare provider to exclude pregnancy before starting treatment with LYNKUET and use effective birth control during and for 2 weeks after stopping treatment. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LYNKUET may affect the way other medicines work, and other medicines may affect how LYNKUET works. What should I avoid while taking LYNKUET? Avoid eating grapefruit or drinking grapefruit juice during treatment with LYNKUET. LYNKUET may cause you to feel drowsy, if you experience this avoid driving and other hazardous activities until these effects go away. LYNKUET can cause serious side effects, including: Central nervous system (CNS) effects and daytime impairment. LYNKUET can cause difficulty staying awake (somnolence) and other nervous system effects including fatigue, having a spinning feeling (vertigo), dizziness, and feeling faint (presyncope). If you experience these effects, you should not drive or do hazardous activities until these effects go away. Increased liver blood test values. LYNKUET may cause increased liver enzymes. Your healthcare provider will do a blood test to check your liver before you start and 3 months after taking LYNKUET. Stop taking LYNKUET and tell your healthcare provider right away if you have the following signs or symptoms that suggest liver problems: feeling more tired than you do usually decreased appetite nausea vomiting itching yellowing of the eyes or skin (jaundice) pale feces dark urine pain in the stomach (abdomen) Risk of pregnancy loss. Taking LYNKUET while pregnant may cause loss of pregnancy or stillbirth. If you think you are pregnant, stop taking LYNKUET and tell your healthcare provider right away. Risk of seizure. Seek medical attention right away if you have loss of consciousness or seizure. Common side effects of LYNKUET include: headache fatigue dizziness feeling drowsy or sleepy stomach (abdominal) pain rash diarrhea muscle spasms Tell your healthcare provider if you have any side effects that do not go away. These are not all the possible side effects of LYNKUET. LYNKUET is available by prescription only. You are encouraged to report side effects or quality complaints of products to the FDA by visiting or calling 1-800-FDA-1088. For Bayer products, you can report these directly to Bayer by clicking here For important information about LYNKUET, please see the Full Prescribing Information About Lynkuet ® (elinzanetant) Lynkuet ® (elinzanetant) 60mg capsules is an FDA-approved, hormone-free prescription treatment for moderate to severe hot flashes due to menopause. Lynkuet is the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist approved for the treatment of moderate to severe hot flashes due to menopause. About the OASIS-1, 2 and 3 trials The FDA approval of Lynkuet ® (elinzanetant) 60mg capsules is supported by data from three Phase III clinical trials that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause. The efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS-1 and OASIS-2, in 796 menopausal women. The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS-1, OASIS-2 and OASIS-3) in 1,420 women. In OASIS-3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. Find more information at Follow us on Facebook: Follow us on X: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References Cordoso, F, Parke S, Brennan DJ, et. al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med 2025;393:753-763. LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026. Huang H, Wei T, Zhang A, et al. Trends in the incidence and survival of women with hormone receptor-positive breast cancer from 1990 to 2019: a large population-based analysis. Sci Rep . 2024;14(1):23690. Published 2024 Oct 10. doi:10.1038/s41598-024-74746-1 Burstein HJ, Temin S, Anderson H, et al. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: American society of clinical oncology clinical practice guideline focused update. J Clin Oncol . 2014;32(21):2255-2269. doi:10.1200/JCO.2013.54.2258 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. doi:10.1001/jama.2024.14618 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. Published online September 8, 2025. doi:10.1001/jamainternmed.2025.0056 Contacts Polina Miklush polina.miklush@bayer.com +1-862-431-8817

Phase 3Clinical ResultDrug Approval

26 Aug 2026

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LYNKUET® (elinzanetant) Receives Expanded Market Authorization in Canada for Treatment of Moderate to Severe Vasomotor Symptoms Caused by Adjuvant Endocrine Therapy (AET) Related to Breast Cancer

Expanded authorization introduces a treatment option for women experiencing moderate to severe hot flashes and/or night sweats caused by adjuvant endocrine therapy (AET) related to breast cancer LYNKUET ® is the first NK-1 and NK-3 receptor antagonist indicated in the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause Expanded indication is supported by the OASIS-4 study, which evaluated treatment in women with moderate to severe VMS caused by adjuvant endocrine therapy for breast cancer 1 MISSISSAUGA, Ontario--(BUSINESS WIRE)--Bayer Inc. announced today that Health Canada has issued a Notice of Compliance (NOC) expanding the indication of LYNKUET ® (elinzanetant) to include the treatment of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy (AET) related to breast cancer. With today’s authorization, LYNKUET ® becomes the first approved treatment option in Canada for this patient population. This authorization builds on Health Canada's July 2025 market authorization of LYNKUET ® for the treatment of moderate to severe VMS associated with menopause. 1 “For women receiving endocrine therapy for breast cancer, hot flashes, night sweats and sleep disruption can have a profound impact on daily life and treatment experience. This market authorization introduces a new treatment option designed to address moderate to severe vasomotor symptoms (also known as hot flashes and night sweats) in a population with limited therapeutic alternatives,” says Viktoria Friedrich, Country President and General Manager for the Pharmaceuticals division in Canada. In a recent Canadian study, moderate to severe VMS were associated with a 30.2% impairment in work productivity and a 35.7% impairment in daily activities. 2 About Vasomotor Symptoms in Women Receiving Adjuvant Endocrine Therapy Breast cancer is the most commonly diagnosed cancer among women in Canada, with approximately 1 in 8 of women expected to develop it during their lifetime. 3 For patients with hormone receptor-positive (HR+) breast cancer, endocrine therapy – such as tamoxifen and aromatase inhibitors – is the standard of care. 4 While endocrine therapy reduces rates of recurrence, it may also cause side effects such as hot flashes, night sweats and sleep disruption that can affect quality of life. 5 Menopause hormone therapy for VMS is not recommended for women with a history of HR+ breast cancer, making effective non-hormonal options an important clinical need. 4,5 Recent Canadian research found that moderate to severe VMS significantly affected quality of life, sleep, work productivity and daily activities among affected women. 2 About the OASIS-4 Study The Phase III OASIS-4 trial evaluated the safety and efficacy of elinzanetant in women receiving adjuvant endocrine therapy who experienced moderate to severe VMS. 6 It is part of the broader OASIS clinical development program investigating elinzanetant in women affected by VMS, which also includes OASIS-1, OASIS-2 and OASIS-3 in postmenopausal women. 6,7,8 Across the OASIS program, elinzanetant demonstrated significant reductions in the frequency of VMS compared to placebo and a safety pro was similar to that of placebo. 6,7,8 About LYNKUET ® LYNKUET ® is a once-daily oral treatment and the first dual neurokinin-targeted therapy, acting as a selective antagonist of both the neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptors. 1 It acts by blocking NK-1 and NK-3 receptor signalling on KNDy neurons, which are hyperactivated due to estrogen decline during menopause or treatment with endocrine therapy, thereby modulating neuronal activity involved in thermoregulation. 1 In Canada, LYNKUET ® is now indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause and for the treatment of moderate to severe VMS caused by adjuvant endocrine therapy (AET) related to breast cancer. 1 Community Perspectives Perspectives from Canada’s health community following today’s announcement: “When we talk about treating breast cancer, we need to ensure patients are supported through treatment. Adjuvant endocrine therapy is one of our most powerful tools for helping prevent recurrence, but it can leave women managing severe hot flashes that negatively affect quality of life and, too often, lead them to stop the very therapy that protects them. For a long time, our options were limited, especially because hormone-based relief is not appropriate for many breast cancer patients. The introduction of LYNKUET ® in Canada is a meaningful step forward. As a hormone-free treatment, it gives us a new, non-hormonal way to treat these ongoing symptoms and help women stay on therapy.” – Dr. Christine Brezen-Masley, Medical Oncologist and Director of the Marvelle Koffler Breast Centre at Mount Sinai Hospital, and Medical Director of the Cancer Program for Sinai Health System in Toronto, Canada. “Breast cancer care can't be done in isolation. We must also address the lasting effects of treatment that shape a person's quality of life. For too long, medically induced menopause symptoms like hot flashes and night sweats have been an overlooked consequence of breast cancer care. The availability of a new non-hormonal treatment reflects the progress that is possible when research drives innovation beyond the cancer itself. It is another step toward a more personalized, evidence-based approach, where survivorship and supportive therapies are recognized as essential components of modern breast cancer care.” – Kimberly Carson, CEO, Breast Cancer Canada “Vasomotor symptoms can have a significant impact on quality of life for people living with breast cancer. For many individuals receiving adjuvant endocrine therapy, symptoms such as hot flashes and night sweats can affect daily functioning and overall wellbeing. The availability of a new treatment option is a welcome step forward in addressing a longstanding gap in care for the breast cancer community.” – Cathy Ammendolea, Chair of the Board of the Canadian Breast Cancer Network “At Rethink, we regularly hear from people on endocrine therapy about how hot flashes, night sweats and disrupted sleep impact their day to day lives. These symptoms aren’t just uncomfortable, they can affect adherence to treatment, mental health, and overall well-being at an already challenging time. What’s particularly significant is that the evidence behind elinzanetant examines it’s use and impact in people with breast cancer, not simply adapted from another population. That kind of disease specific focus is important, and we’re encouraged to see it reflected here.” – MJ DeCoteau, Founder & Executive Director, Rethink Breast Cancer About Women’s Health at Bayer Bayer is committed to delivering Health for All by advancing a portfolio of innovative treatments in women's health. Bayer offers a wide range of contraceptive options, therapies for menopause management and gynecological conditions, and continues to invest in research and development to address unmet needs across women's health including menopause, endometriosis and oncology-related quality-of-life care. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to . Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. References: Bayer Inc. Lynkuet ® (elinzanetant) Product Monograph . August 12, 2026. Available at: Yuksel N, Todorova L, Scrine L, Rea C, Bouchard C. Prevalence and impact of vasomotor symptoms due to menopause among women in Canada: A subgroup analysis from the Women with Vasomotor Symptoms Associated with Menopause (WARM) Study. Menopause. 2025;32(1):38-44. Canadian Cancer Society. Hormone therapy for breast cancer . Accessed July 2026. Available at: Yuksel N, Evaniuk D, Huang L, et al. Guideline No. 422a: Menopause: Vasomotor Symptoms, Prescription Therapeutic Agents, Complementary and Alternative Medicine, Nutrition, and Lifestyle. J Obstet Gynaecol Can . 2021;43(10):1188-1204. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for vasomotor symptoms from endocrine therapy for breast cancer. N Engl J Med. Published online June 2, 2025. 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. doi:10.1001/jama.2024.14618. Panay N, Joffe H, Maki PM, et al. Efficacy and long-term safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS-3. JAMA Intern Med. 2025;185(11):1319-1327. Contacts Contact for media inquiries: Communications Department Bayer Inc. mediacanada@bayer.com Find more information at

Clinical ResultPhase 3Drug Approval

100 Deals associated with Elinzanetant

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KEGG	Wiki	ATC	Drug Bank
D12123	Elinzanetant	G02CX07	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Vasomotor symptom	Australia	Bayer Australia Ltd.	11 Sep 2025
Hot Flashes	Canada	Bayer, Inc.	01 Jul 2025

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Initiation and Maintenance Disorders	Phase 2	United States	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Austria	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Belgium	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Czechia	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Germany	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Poland	Bayer AG	08 Nov 2023
Sleep Initiation and Maintenance Disorders	Phase 2	Spain	Bayer AG	08 Nov 2023
Dyssomnias	Phase 2	United States	Bayer AG	20 Nov 2018
Dyssomnias	Phase 2	United States	NeRRe Therapeutics Ltd.	20 Nov 2018
Dyssomnias	Phase 2	Canada	NeRRe Therapeutics Ltd.	20 Nov 2018

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05587296 (OASIS-4, ESMO2026)	Phase 3	Vasomotor symptom	419	EZN 120 mg	czuaxejwja(elegcwtlmw) = axrnuvqdad qjavesmwnk (xcmqremgvf, 10.5 - 13.9) View more	Positive	23 Oct 2026
				Placebo	czuaxejwja(elegcwtlmw) = ezyiuzhkdm qjavesmwnk (xcmqremgvf, 10.0 - 13.7) View more
ENDO 12026 \| ENDO 22026	Phase 3	Vasomotor symptom	3,331	Elinzanetant	lhlpnbilfo(acsoelljrj): RR = 1.35 (95.0% CI, 0.3 - 2.63) View more	Positive	15 Jun 2026
				Fezolinetant
NCT05042362 (OASIS-1 \| OASIS 1, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	396	Elinzanetant (Elinzanetant 120 mg)	euyetyxacu(wwpgddcqkh) = kjdajimshj zgwlmlcsza (bkghedqglu, 6.57) View more	-	12 Feb 2026
				Placebo+Elinzanetant (Placebo - Elinzanetant 120 mg)	euyetyxacu(wwpgddcqkh) = iqohtugugr zgwlmlcsza (bkghedqglu, 13.94) View more
NCT05099159 (OASIS 2 \| OASIS-2, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	400	Elinzanetant (Elinzanetant 120 mg)	qjtyyhkorq(ibcigfojzv) = lfqcqdigbh bixhhfchfv (etdfbzswho, 11.08) View more	-	12 Feb 2026
				Placebo+Elinzanetant (Placebo - Elinzanetant 120 mg)	qjtyyhkorq(ibcigfojzv) = xgqqpfieon bixhhfchfv (etdfbzswho, 11.15) View more
NCT05030584 (OASIS 4 \| OASIS 3 \| OASIS-3, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	628	Elinzanetant (BAY3427080) (Elinzanetant (BAY3427080))	dzbjqoyjpc(tbmzakzfne) = chynbrqzun oecqlaciox (nyhdlcijxr, 7.15) View more	-	01 Dec 2025
				Placebo (Placebo)	dzbjqoyjpc(tbmzakzfne) = mvudmkrjej oecqlaciox (nyhdlcijxr, 6.15) View more
NCT05030584 (OASIS-3, Pubmed \| JAMA Intern Med)	Phase 3	Vasomotor symptom	628	Elinzanetant 120 mg	xrwbanflen(uhxlrzqmth) = numerical advantages for elinzanetant vs placebo for improving VMS frequency and severity fnnsrrxkkk (jvdzglkdou ) View more	Positive	01 Nov 2025
				Placebo
OASIS 1 (Pubmed \| Patient)	Phase 3	Vasomotor symptom	40	Elinzanetant	sfcvwtgmfb(tnpzffqfvy) = stpeechtkk kvbjebhtge (jzlxxwvkfv ) View more	Positive	01 Nov 2025
NCT05587296 (OASIS 4 \| OASIS-4, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	474	Elinzanetant (BAY3427080)	mumtjgzqcn(qilibhofqm) = gtztfxxvck izzoslbogm (yirmqumzfd, 6.89) View more	-	29 Oct 2025
NCT05099159 \| NCT05042362 (OASIS 1, FDA_CDER) Manual	Phase 3	Vasomotor symptom	796	LYNKUET 120 mg (OASIS 1)	kpbuojgdho(rhtxrxfgpn) = lspoulfpae tflvhgpxnh (rcbtqrahkb, 0.43) View more	Positive	24 Oct 2025
				Placebo (OASIS 1)	kpbuojgdho(rhtxrxfgpn) = wydyhwaenv tflvhgpxnh (rcbtqrahkb, 0.43) View more
NCT05587296 (OASIS 4, ASCO2025) Manual	Phase 3	Vasomotor symptom \| Hormone receptor positive breast cancer Adjuvant	-	Elinzanetant 120 mg	vsgatvobkc(qfrhloyxty) = apphufjukj rwjizxgkdn (aeqgbirbbm, 1.1) View more	Positive	30 May 2025
				Placebo	vsgatvobkc(qfrhloyxty) = jhjbetstwy rwjizxgkdn (aeqgbirbbm, 1.2) View more

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