Elinzanetant, a second neurokinin-blocking hot flash pill, is approved in the US, UK and EU

2025-10-24

Elinzanetant, sold as Lynkuet, is a once-daily non-hormonal pill for moderate to severe hot flashes, approved in the UK in July 2025, the US in October 2025 and the EU in November 2025. In trials it cut hot flashes more than placebo, but long-term data are still limited.

Researched by the MenoWoman team. Edited by Marcela Sat. Updated 7 November 2026. We may earn from links.

See a doctor if hot flashes disrupt your sleep or daily life, and seek prompt advice if you take this medicine and notice yellowing skin or eyes, dark urine, unusual tiredness or a seizure.

What happened

The UK medicines regulator was the first to approve elinzanetant, in July 2025.¹ The US FDA approved it on 24 October 2025 for moderate to severe hot flashes caused by menopause.^2,3 The European Union followed on 17 November 2025.⁴

By late October 2025, it was also approved in Australia, Canada and Switzerland.⁵ Approval does not always mean a medicine is available or covered in every country, so ask your doctor or pharmacist locally.

How it works

Falling estrogen affects a group of brain cells that help control body temperature. Elinzanetant blocks two signaling receptors in this system, called NK1 and NK3.¹

It is the second drug of this kind. The first, fezolinetant (Veozah), blocks only NK3.⁶ Experts think the extra NK1 action may help sleep, but it may also cause sleepiness.⁶

In the EU, it is also approved for hot flashes caused by hormone-blocking treatment after breast cancer.⁴

What the trials showed

Approval was based on three trials called OASIS, with about 1,400 women aged 40 to 65.^1,2 In the year-long OASIS 3 trial, women started with about 7 moderate to severe hot flashes a day.²

After 12 weeks, the elinzanetant group averaged about 1.3 a day, compared with 3.3 on placebo.² Sleep scores also improved more than with placebo.³

The most common side effects were headache, tiredness and drowsiness or dizziness.^1,5 More women stopped the drug because of side effects than stopped placebo (12.5% vs 4%).² The US label warns about drowsiness and next-day impairment, including for driving, rises in liver enzymes, pregnancy loss, and seizures in people with a history of seizures. Liver blood tests are needed before starting and again after about 3 months, and it must not be used in pregnancy.⁷

What it means for you, and what it does not

For women who cannot or prefer not to use hormone therapy, this adds another option to discuss with a doctor. See our page on non-hormonal prescription treatments.

It does not treat vaginal dryness, joint aches or other menopause symptoms.⁶ It is not yet clear whether it works better than fezolinetant.⁶

Most data cover six to twelve months. Few women from some ethnic groups, or with severe obesity, took part.² Fezolinetant gained a liver warning after it reached the market, so experts say liver safety needs watching.²

Trials also left out women taking some other medicines, so interactions are less well known.² For mild or occasional hot flashes, lifestyle changes may still be a sensible first step.²

Questions to ask your doctor

Is my hot flash pattern moderate or severe enough for a prescription medicine?
How does this compare with hormone therapy or other non-hormonal options for me?
Which blood tests will I need, and when?
Could it interact with anything else I take?
Is it available and covered where I live?

These questions do not replace medical advice. They can help you get more from a short appointment.

Elinzanetant, a second neurokinin-blocking hot flash pill, is approved in the US, UK and EU

What happened

How it works

What the trials showed

What it means for you, and what it does not

Questions to ask your doctor

Related

Sources