The National Institute for Health and Care Excellence has recommended the Menopause NHS Non Hormonal Drug fezolinetant to help women experiencing moderate-to-severe hot flushes who cannot take hormone replacement therapy. This decision could provide relief to around 500,000 people across the United Kingdom.
NICE Recommends First Neurokinin-Targeted Menopause Therapy
Britain’s medicines assessment body issued final draft guidance supporting fezolinetant as a treatment for moderate-to-severe vasomotor symptoms such as hot flushes and night sweats. The drug offers a new prescribing option for general practitioners when hormone replacement therapy, or HRT, is unsuitable.
The once-daily 45-milligram tablet, known as the Menopause NHS Non Hormonal Drug fezolinetant, works by blocking neurokinin B, a neurotransmitter in the brain associated with temperature regulation changes that trigger hot flushes. It is the first neurokinin-3 receptor antagonist to be recommended by NICE for menopause-related symptoms.
NICE estimates that roughly 500,000 people in the U.K. could qualify for the treatment. More than two million people nationwide experience moderate-to-severe menopause-related hot flushes and night sweats.
Despite the recommendation, NICE emphasized that HRT remains the primary treatment for vasomotor symptoms in most patients.
“Clinical trial evidence suggests that fezolinetant decreases the frequency and severity of moderate to severe symptoms compared with placebo,” the agency said in the guidance.
Experts Say Drug Expands Limited Options for Patients
Health experts said the recommendation could provide relief for women who cannot take hormone-based therapy because of medical risks.
Helen Knight, director of medicines evaluation at NICE, said menopausal symptoms can significantly affect daily life.
“We know that menopausal hot flushes and night sweats can have a profound impact on quality of life and overall well-being,” Knight said. “For those unable to take HRT, options have historically been limited.”
She added that the evidence shows fezolinetant can reduce symptoms and is cost-effective for the National Health Service.
Dr. Katie Barber, a general practitioner and menopause specialist, said many patients with severe symptoms often feel they have few treatment choices.
“Every month, women with debilitating symptoms, where HRT is not recommended or desired, come to me saying, ‘I’ve been told there’s nothing else for me,’” Barber said. “This decision introduces an effective choice for a sizeable number of women.”
Dr. Vikram Talaulikar, an associate specialist in reproductive medicine at University College London, said the guidance represents progress in women’s health care.
“NICE’s decision means that NHS doctors now have access to the Menopause NHS Non Hormonal Drug as an alternative treatment designed to improve specific symptoms of menopause,” Talaulikar said. “It provides women with a wider choice of options.”
Clinical Trials Support Drug, but Safety Limits Remain
Fezolinetant was developed by Astellas Pharma and evaluated through the BRIGHT SKY research program. The development effort included three randomized phase 3 clinical trials involving more than 2,800 participants across Europe, the United States, and Canada.
NICE highlighted that although trials demonstrated the Menopause NHS Non Hormonal Drug fezolinetant reduced both the frequency and severity of symptoms, it has not yet been directly compared with other non-hormonal options. Indirect analyses indicate similar effectiveness, but some uncertainty remains.
The medication is not recommended for people with current breast cancer, other estrogen-dependent cancers, or liver disease. Patients must undergo liver function tests before beginning treatment and during therapy.
Women who previously had breast cancer or estrogen-dependent cancers may be considered for treatment only after an individual risk assessment because clinical trial data in those groups are limited.
The decision comes as the U.K. government expands attention to menopause care. The National Health Service is working to add menopause-related questions to routine NHS Health Checks.
Health Secretary Wes Streeting said incorporating menopause screening will help raise awareness and encourage patients to seek medical advice.
Officials say the broader effort aims to improve recognition and treatment of menopause symptoms affecting millions of women.
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