The Medicines and Healthcare products Regulatory Agency (MHRA) has approved elinzanetant (Lynkuet, Bayer) for treating moderate to severe vasomotor symptoms associated with menopause.
The decision marks the first global authorisation of this non-hormonal therapy for hot flushes and night sweats in women who cannot, or choose not to, use hormone-based therapies.
How it Works
Elinzanetant is an oral dual neurokinin-1 (NK1) and neurokinin-3 (NK3) receptor antagonist. It works by modulating kisspeptin/neurokinin B/dynorphin (KNDy) neuron activity in the hypothalamus, restoring thermoregulatory balance disrupted by declining oestrogen levels during menopause.
The treatment is administered as a once-daily tablet.
Clinical Trial Evidence
The approval was based on results from three phase 3 trials — OASIS 1, 2, and 3— which collectively enrolled more than 1400 women aged 40-65.
Compared with placebo, a once-daily 120 mg dose of elinzanetant significantly reduced both the frequency and severity of vasomotor symptoms. Improvements were observed as early as week 1 and were maintained until week 52.
Participants also reported improvements in sleep quality and overall quality of life.
Safety and Monitoring
Most adverse events were mild to moderate. The most common side effects included headache, fatigue, and somnolence. Liver function should be monitored during treatment.
Julian Beach, interim executive director of healthcare quality and access at the MHRA, said that elinzanetant “has met the MHRA’s standards for safety, quality and effectiveness.”
A full summary of product characteristics and the patient information leaflet will be published on the MHRA website within 7 days of approval.
Clinicians are encouraged to report any suspected adverse reactions via the Yellow Card scheme.