Astellas’ Veoza Menopause Drug Application Accepted in China

On Oct 26, 2026

Astellas Pharma has announced that China’s National Medical Products Administration (NMPA) has accepted a new drug application for Veoza (fezolinetant) 45 mg, a non-hormonal treatment for moderate to severe menopause symptoms. The application was accepted on October 27, 2026, and seeks approval to treat hot flashes and night sweats associated with menopause.

Hot flashes and night sweats, also known as vasomotor symptoms (VMS), are common during menopause. These symptoms can affect sleep, daily activities and overall quality of life. According to Astellas, around 55% of women aged 40 to 65 across East Asia, including mainland China, have experienced moderate to severe vasomotor symptoms.

Veoza is a non-hormonal medicine designed to help reduce the frequency and severity of these symptoms. It works by blocking the neurokinin 3 (NK3) receptor pathway, which plays a role in the brain’s regulation of body temperature. By targeting this pathway, fezolinetant aims to help women manage menopause-related hot flashes and night sweats without hormone-based treatment.

The application is supported by data from Astellas’ global Phase 3 BRIGHT SKY clinical programme, a new bridging study conducted in China and previously completed clinical studies in the country. The global BRIGHT SKY programme included more than 1,000 women with moderate to severe vasomotor symptoms across its two main trials, SKYLIGHT 1 and SKYLIGHT 2.

Astellas also conducted a Phase 2 study in China involving 150 women. The study evaluated the safety and effectiveness of fezolinetant 45 mg compared with a placebo over 12 weeks.

Across the clinical programmes, fezolinetant was generally well tolerated, according to the company. Commonly reported side effects included headache, abdominal pain, diarrhoea, insomnia and back pain.

Veoza is currently approved in 50 countries worldwide for treating moderate to severe vasomotor symptoms associated with menopause. However, the medicine is not yet approved in China. Acceptance of the application means the regulatory review can proceed; it does not mean that marketing approval has been granted.

The latest development marks another step in Astellas’ efforts to expand access to non-hormonal treatment options for women experiencing menopause symptoms. The company continues to focus on women’s health and treatments for conditions with significant unmet medical needs.