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 www.bayer.com.

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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 www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

References

  1. LYNKUET® (elinzanetant) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; August 2026.

  2. Yu L, et al. Behav Sleep Med 2011;10(1):6–24.

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