Introduction
Vasomotor symptoms ( hot flashes, night sweats) and sleep disturbances are among the most common and distressing symptoms of menopause, affecting nearly 75–80% of women. For decades, hormone therapy has been the gold standard for treating hot flashes and night sweats associated with menopause. However, many women cannot or choose not to take hormonal treatments due to health concerns or personal preference.
Now, a breakthrough offers new hope — Lynkuet (Elinzanetant), a non-hormonal drug approved by the U.S. Food and Drug Administration (FDA) on October 24, 2025, for the treatment of moderate to severe vasomotor symptoms associated with menopause, developed by Bayer Healthcare.
Why a Non-Hormonal Option Was Needed?
While hormone therapy remains the most effective first-line treatment, many women prefer or require non-hormonal alternatives due to:
- Concerns about breast cancer or cardiovascular risks
- Weight gain worries
- Medical reasons that may prevent the use of hormone therapy (e.g., prior cancers, blood-clotting risk)
Lynkuet offers a much-needed hormone-free treatment for controlling hot flashes and night sweats.
How Lynkuet Works?
Lynkuet works through a unique, non-hormonal mechanism. Its active ingredient, Elinzanetant, is a dual receptor antagonist that blocks neurokinin-1 (NK1) and neurokinin-3 (NK3) receptors.
Here’s how it helps:
- These NK₁ and NK₃ receptors are located in the hypothalamus, the brain’s temperature-regulating centre.
- During menopause, falling estrogen levels make specific neurons overactive, disrupting temperature balance and causing hot flashes.
- By blocking these receptors, Lynkuet calms overactive neurons, helping restore temperature stability.
Clinical Evidence Behind the Approval
The FDA approval is supported by data from three Phase 3 clinical studies, OASIS 1, 2, and 3, which assessed the efficacy and safety of Elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause. Throughout all three studies, Lynkuet (Elinzanetant) consistently showed positive results.
🔑 Key Findings
- ✅ Rapid and sustained reduction in the frequency and severity of hot flashes.
- ✅ Improved sleep quality and overall daily functioning.
- ✅ Well-tolerated with a favorable safety profile.
Dosage form , Strength & Administration
- Lynkuet is available as 60 mg soft gel capsules for oral use.
- Dose: two 60 mg capsules (120 mg total) once a day at bedtime.
- You can take it with or without food.
- Do not cut, crush, or chew the capsules — swallow them whole with water.
Common Side Effects
The most common side effects reported in studies were:
- 🤕 Headache
- 😴 Tiredness or fatigue
- 💤 Somnolence (Excessive sleepiness)
Real-World Accessibility and Cost
Lynkuet (Elinzanetant) is expected to be available in the U.S. starting in November 2025. It is already approved in Australia, Canada, the United Kingdom, and Switzerland. It’s currently pending approval in the European Union and is under review in other countries worldwide.
The drug costs $625 wholesale per month in the US, but patient costs vary depending on the insurance plan. The company partnered with online pharmacy BlinkRx, allowing eligible patients to pay as little as $25 through the Lynkuet Access, Savings, and Support program.
Potential Issues and Concerns
💤Daytime Drowsiness and Dizziness
- Lynkuet may make some people feel sleepy, tired, or lightheaded. It’s best not to drive or operate machinery until you know how the medicine affects you.
🩺 Liver Issues
- In some cases, Lynkuet can affect the liver. Your doctor will do a blood test before starting and again after a few months to check liver function.
- Stop the medicine and see a doctor right away if you notice yellowing of the skin or eyes (jaundice), nausea, or stomach pain.
- Not recommended in a patient with moderate to severe liver disease.
📉 Long-Term Data
- Long-term safety (over multiple years) and real-world effectiveness still need evaluation.
💸 Access & Cost Concerns
- Affordability might remain a concern, especially in regions where traditional hormonal therapies are significantly less expensive. Broader insurance coverage, a patient-assistance programme, and eventual price adjustments will be vital to ensuring that this innovation reaches all women who could benefit from it.
Final Takeaway
Lynkuet (Elinzanetant) represents an exciting step forward in menopause care, offering women a non-hormonal, effective, and safe option to help manage hot flashes and night sweats. By focusing on the neurokinin pathways in the brain instead of hormone levels, it provides relief without the risks that come with traditional hormone therapy, giving women more choice and confidence during menopause.
👉However, as Lynkuet (Elinzanetant) enters the market, its real-world experience will offer a clearer understanding of its long-term safety and effectiveness across diverse populations beyond clinical trials.. Also, cost and accessibility may initially restrict its widespread adoption.
Further Reading
- Pinkerton, J. V., Simon, J. A., Joffe, H., Maki, P. M., Nappi, R. E., Panay, N., … Zuurman, L. (2024). Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA, 332(16), 1343–1354. https://doi.org/10.1001/jama.2024.14618 JAMA Network+1
- Panay, N., Joffe, H., Maki, P. M., et al. (2025). Elinzanetant for the treatment of vasomotor symptoms associated with menopause: A phase 3 randomized clinical trial. JAMA Internal Medicine. Advance online publication. https://doi.org/10.1001/jamainternmed.2025.4421 JAMA Network
- Pinkerton, J. V., Simon, J. A., Nick, P., et al. (2024, June 1). Design of OASIS 1 and 2: phase 3 clinical trials assessing the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause. Menopause, 31(6), 522–529. https://doi.org/10.1097/GME.0000000000002350 PubMed
- Willmann, S., Lloyd, A., Austin, R., Joseph, S., Solms, A., Zhang, Y., … Schultze-Mosgau, M-H. (2024). Population pharmacokinetic–pharmacodynamic model of elinzanetant based on integrated clinical phase I and II data. CPT: Pharmacometrics & Systems Pharmacology, 13(12), 2137–2149. https://doi.org/10.1002/psp4.13226 PubMed
- McNulty, R. (2025, October 24). FDA approves elinzanetant, a hormone-free option for hot flashes in menopause. The American Journal of Managed Care. https://www.ajmc.com/view/fda-approves-elinzanetant-a-hormone-free-option-for-hot-flashes-in-menopause AJMC
- Bayer HealthCare Pharmaceuticals Inc. (2025, October). LYNKUET® (elinzanetant) capsules, for oral use: Full prescribing information. U.S. Food & Drug Administration. Retrieved from https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf
- Reuters. (2025, October 24). US FDA approves Bayer’s menopause relief drug. Reuters. https://www.reuters.com/sustainability/boards-policy-regulation/us-fda-approves-bayers-menopause-relief-drug-2025-10-24/
