On October 24, 2025, the U.S. Food & Drug Administration (FDA) approved Lynkuet, a once-daily, non-hormonal capsule for the treatment of moderate-to-severe vasomotor symptoms commonly experienced during menopause such as hot flashes. The therapy is already approved in Australia, Canada, the United Kingdom and Switzerland, and its U.S. launch is expected in November 2025.
The active substance in Lynkuet is Elinzanetant, a selective dual antagonist of the neurokinin-1 (NK-1) and neurokinin-3 (NK-3) receptors. Elinzanetant works by blocking NK-1 and NK-3 receptor signaling, which is believed to normalize neuronal activity in the hypothalamus, particularly in the KNDy neurons (kisspeptin/neurokinin B/dynorphin neurons). These neurons are involved in regulating body temperature and sleep.
During menopause, declining estrogen levels can lead to the hyperactivation of these neurons, disrupting thermoregulation and contributing to hot flashes and sleep disturbances. By targeting both NK-1 and NK-3 receptors, elinzanetant aims to restore normal neuronal signaling, thereby alleviating these symptoms.
Clinical trials have shown that Lynkuet significantly reduces the frequency and severity of hot flashes while also improving sleep disturbances, a common consequence of menopausal symptoms. These findings highlight its potential to address both daytime and nighttime discomfort associated with menopause.
The approval of Lynkuet offers a valuable option for women who cannot or prefer not to use hormone replacement therapy (HRT), addressing a long-standing need for effective non-hormonal treatments. Clinicians may now reconsider management strategies for menopausal vasomotor symptoms, potentially incorporating Lynkuet into treatment plans and expanding individualized care.
Beyond its immediate clinical use, Lynkuet’s approval is likely to stimulate competition and innovation in the field of menopause management, encouraging further development of therapies tailored to women’s health needs.
Disclaimer: This article is intended for informational and educational purposes only. It does not constitute medical advice or endorsement. Treatment decisions should be guided by a qualified healthcare professional.
