• Authorization is supported by data from the Phase III OASIS clinical trial program evaluating LYNKUET^® for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes or night sweats) associated with menopause[i]               

• In OASIS 1 and OASIS 2, LYNKUET^® reduced the frequency and severity of moderate to severe VMS day and night from baseline to weeks 4 and 12 compared to placebo.

• VMS are reported as the most disruptive symptom of menopause[ii] and may impact women differently.[iii]

Mississauga, Canada, July 25, 2025 – Bayer announced today that Health Canada has issued a Notice of Compliance (NOC) for LYNKUET^® (elinzanetant capsules) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes or night sweats) associated with menopause. LYNKUET^® is a neurokinin 1 (NK-1) and neurokinin 3 (NK-3) receptor antagonist. Inhibition of NK-1 and NK-3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in the thermoregulatory centre associated with hot flashes.

In Canada, more than 10 million women are aged 40 and over,[iv] representing approximately one-quarter of the population.[v] The Menopause Foundation of Canada reports that 95% of women aged 40-65,  will experience menopausal symptoms, with those most commonly reported being hot flashes and night sweats.[vi] Hot flashes and night sweats are described as being among the most bothersome symptoms of menopause[vii] and can begin years before menopause and occur multiple times a day or night.[viii] For many, these symptoms disturb sleep, reduce concentration, and significantly affect quality of life, with about 25% of women 40-60 reporting disruption to daily activities, and 10% indicating a decision was made to leave the workforce as a result.[ix] On average, symptoms can persist for seven to eight years, and in some cases, continue for a decade or more.[x]

“Caring for women in menopause requires a personalized, evidence-based approach rooted in shared decision-making,” said Dr. Elissa Weinberg, Family physician in Toronto with a focused practice in menopause care. “Each woman’s journey is unique, shaped by her symptoms, medical history, and personal preferences. It is exciting to have another non-hormonal option to help manage bothersome vasomotor symptoms for women who cannot or prefer not to use hormone therapy”

Authorization for LYNKUET^® is supported by data from three Phase III clinical trials (OASIS 1, OASIS 2 and OASIS 3) that evaluated the efficacy and safety of LYNKUET^® for the treatment of moderate to severe VMS associated with menopause.

“These three studies investigated the safety profile and efficacy of elinzanetant for the treatment of moderate to severe VMS due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and OASIS Lead Investigator. “Hot flashes can come on suddenly and present as a feeling of intense heat and severe hot flashes can be disruptive. This approval provides women with a new, hormone-free treatment option to reduce the frequency and severity of moderate to severe hot flashes due to menopause.” 

“Health Canada’s market authorization of LYNKUET^® is an important milestone in the evolving landscape of care for women experiencing moderate to severe vasomotor symptoms associated with menopause,” said Shurjeel Choudhri, Senior Vice President and Head of Medical and Scientific Affairs for Bayer Canada. “As part of Bayer’s longstanding commitment to women’s health, we are proud to support greater awareness and dialogue around this life stage and the options available to help manage its impact.” 

About Women’s Healthcare at Bayer

Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare, Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.

About Bayer 

Bayer is a global enterprise with core competencies in the life sciences 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 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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 billion euros. For more information go to www.bayer.ca.

Contact for media inquiries:

Communications Department

Bayer Inc.

mediacanada@bayer.com

Find more information at www.bayer.ca.

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