Fezolinetant (Veoza): the new non-hormonal pill for hot flushes

For decades, the conversation about menopausal hot flushes revolved almost entirely around hormones. Fezolinetant, sold in Spain under the brand name Veoza, is different: it is a non-hormonal medicine, and it is the first of its class to reach the pharmacy with an approved indication for this symptom. Here we explain what it is, what the published studies say and what warnings come with it. This is not an article to help you decide whether it is right for you: that is a conversation with your doctor. It is an article to help you understand what lies behind the name.

It is authorised in Spain, but with liver monitoring

Veoza is authorised and marketed in Spain. The specific product is Veoza 45 mg film-coated tablets, from Astellas Pharma Europe B.V., with a centralised European authorisation valid in Spain (CIMA registration no. 1231771001). Its approved indication is the treatment of moderate to severe vasomotor symptoms (hot flushes and night sweats) associated with the menopause. It requires a prescription.

It is a medicine subject to additional monitoring, which in Europe is flagged with an inverted black triangle: it means the authorities are keeping a special watch on its safety. And there is one specific warning that should not be overlooked. On 2 December 2024, the Spanish Medicines Agency (AEMPS) issued new recommendations to prevent liver injury: liver function tests must be carried out before starting and every month during the first three months. This is not an over-the-counter medicine, nor one that can be taken without blood tests.

An honest note: as to whether its funding by the Spanish National Health System is confirmed or not, we cannot state that here because we have not verified it in a primary source. We do not assume that it is publicly funded, and we do not quote a public price.

What it is and how it works

Fezolinetant is a selective, non-hormonal neurokinin 3 (NK3) receptor antagonist. This matters: it is not a hormone, and it should not be understood as hormone therapy or as a natural version of it. It works through a different pathway.

According to the summary of product characteristics, it blocks the binding of neurokinin B in certain hypothalamic neurons known as KNDy neurons, which form part of the centre that regulates body temperature. In doing so, it reduces the frequency and intensity of hot flushes. That is its only declared target: it is not indicated for other menopausal symptoms such as vaginal dryness, osteoporosis or mood. It treats vasomotor symptoms, not the menopause as a whole.

The authorised dose is 45 mg once a day. A 30 mg dose was also studied in the trials, but that one is not approved: the only authorised dose is 45 mg.

Watch out for brand names and dates

It is easy to get confused, because the same active ingredient has two names. In the United States it is called Veozah and the FDA approved it on 12 May 2023, as the first NK3 antagonist for this indication. In the European Union and Spain it is called Veoza: the EMA's CHMP issued a positive opinion on 12 October 2023 and the marketing authorisation valid across the EU dates from 7 December 2023. They are not the same date or the same brand, and information from the United States should not be used as though it applied to Spain.

What the trials found

The pivotal evidence came from two phase 3 trials, SKYLIGHT 1 and SKYLIGHT 2: double-blind, placebo-controlled, 12 weeks long, with an active extension of a further 40 weeks (52 in total). They involved women aged 40 to 65 with at least 7 moderate or severe hot flushes a day.

In SKYLIGHT 2, at 12 weeks, the mean (least squares) reduction in the frequency of vasomotor symptoms was -7.50 a day with the 45 mg dose and -6.83 with the 30 mg dose. Severity fell by -0.77 points with 45 mg and by -0.64 with 30 mg.

That said, the figure that really matters is not how much hot flushes fell in the group taking the medicine, but how much they fell compared with placebo, because in these trials placebo also reduces symptoms considerably. In the pooled analysis of SKYLIGHT 1 and 2 (341 women on 45 mg versus 342 on placebo), the difference versus placebo with the 45 mg dose at 12 weeks was -2.51 hot flushes a day, with a 95% confidence interval of -3.20 to -1.82. That is the effect attributable to the medicine over and above placebo: real and statistically significant, and at the same time more modest than the standalone figure for the treated group.

A clarification about what these data do not say: the comparator in the pivotal trials was placebo, not hormone therapy. There is no direct head-to-head comparison establishing that fezolinetant is superior or inferior to hormones. Anyone claiming that is going beyond what has been published.

Side effects and warnings

Among the most common adverse reactions listed in the summary of product characteristics are diarrhoea (3.2%), insomnia (3.0%) and raised ALT and AST transaminases (classified as common).

The most relevant safety signal concerns the liver. Cases have been reported of transaminases rising above 10 times the upper limit of normal, sometimes accompanied by raised bilirubin or alkaline phosphatase and by symptoms. That is why, in December 2024, the AEMPS strengthened monitoring: liver function tests before starting and monthly during the first three months. Presenting this medicine as if it carried no risks would be dishonest.

The summary of product characteristics also lists contraindications: use alongside moderate or strong CYP1A2 inhibitors (for example, fluvoxamine), pregnancy or suspected pregnancy, and hypersensitivity to the medicine.

What is available in Spain today

There is a non-hormonal option authorised in Spain for moderate to severe hot flushes, which works through a different pathway from hormones, with a real but limited effect and regular liver monitoring that is not optional. It is a prescription medicine: who can take it, and in what circumstances, is a medical decision, not one for an article.

If hot flushes or other menopausal symptoms are affecting you, there is no need to wait for them to "go away on their own". What does exist in Spain today is menopause treatment with a prior assessment, prescription when appropriate by a registered doctor, and ongoing follow-up, in which the doctor weighs up which option makes sense in your case. The first step is to check whether you are eligible.