• This approval is supported by data from the Phase III OASIS clinical trial program evaluating Lynkuet for the treatment of moderate to severe hot flashes due to menopause¹
• In OASIS 1 and OASIS 2, Lynkuet met the co-primary endpoints of reduction in number and severity of moderate to severe hot flashes day and night at weeks 4 and 12 from baseline¹
• Hot flashes are a common symptom of menopause² and one of the main reasons women seek treatment;³ hot flashes may impact women differently⁴ and some can be disruptive⁵

WHIPPANY, N.J. / Oct 24, 2025 / Business Wire / Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Lynkuet^® (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy,¹ neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause.¹ Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in the thermoregulation associated with hot flashes.¹ Lynkuet soft gel capsules are taken once daily at bedtime, with or without food.¹ The FDA approval is supported by data from three Phase III clinical trials (OASIS 1, OASIS 2 and OASIS 3) that evaluated the safety and efficacy of Lynkuet for the treatment of moderate to severe hot flashes due to menopause.¹

"The FDA approval of Lynkuet is an important new option for women and providers who are treating moderate to severe hot flashes due to menopause," said Yesmean Wahdan, M.D., Head of Medical Affairs USA & North America at Bayer. "As a global leader in women’s healthcare with more than 100 years of research and experience, we are proud to bring this new treatment option to market for women who are going through menopause and seeking hot flash relief."

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, including day and night hot flashes.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.¹

It’s important to know that women who are pregnant should not take Lynkuet. Lynkuet can cause serious side effects, including central nervous system effects and daytime impairment, increased liver blood test values, risk of pregnancy loss, and risk of seizures in people with a history of seizures. The common side effects of Lynkuet include headache, fatigue, dizziness, feeling drowsy or sleepy, stomach (abdominal) pain, rash, diarrhea, and muscle spasms.¹ For more information, please see “Important Safety Information” below.

“These studies investigated the safety and efficacy of elinzanetant for the treatment of moderate to severe hot flashes due to menopause,” said JoAnn Pinkerton, M.D., Professor and Director of Midlife Health at UVA Health and Lead Investigator on the OASIS 2 trial. “Hot flashes, particularly when severe, can have an impact on women’s daily lives and this approval provides healthcare providers with a new treatment option that can be used first-line for moderate to severe hot flashes due to menopause.”

“It’s important that women know they have choices for treating moderate to severe hot flashes due to menopause, and today’s approval further expands a woman’s options for treating these symptoms,” said Claire Gill, President and Founder of the National Menopause Foundation.

As a leader in women’s healthcare, Bayer is committed to making Lynkuet accessible. Through the Lynkuet Access Savings & Support program (LASS), women can connect with a healthcare provider and receive their Lynkuet prescription from home and at the lowest cost available to them. Visit Lynkuet.com to learn more about how to save on Lynkuet. If a patient cannot afford their prescription, Bayer may be able to help. Eligible patients may receive their Bayer prescription medicine at no cost through the Bayer U.S. Patient Assistance Foundation. For more information, please visit www.patientassistance.bayer.us or call to speak with a member of Bayer’s team at 1-866-2BUSPAF (228-7723).

Lynkuet is expected to be available in the U.S. beginning in November 2025. Elinzanetant is approved under the brand name Lynkuet^TM in Australia, Canada, the United Kingdom and Switzerland. It is pending approval in the European Union and under review in other markets around the world.

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
• 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 seizures in people with a history of seizures. 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 www.fda.gov/medwatch 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 accompanying Full Prescribing Information.

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 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.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.

Disclosures

Claire Gill of The National Menopause Foundation is a long-standing advocacy partner of Bayer and has received financial compensation for her contributions.

References