Bayer’s Lynkuet (elinzanetant) Wins First-in-World Approval in UK, Challenging Astellas’ Hot Flash Drug

Bayer's elinzanetant, branded as Lynkuet, has received its first worldwide regulatory approval in the UK for the treatment of moderate to severe vasomotor symptoms (hot flashes) associated with menopause134.

The approval was granted by the UK Medicines and Healthcare products Regulatory Agency (MHRA) on July 8, 2025, marking the first time any authority has approved this medication13.

Elinzanetant is a non-hormonal, oral therapy designed to address menopausal vasomotor symptoms by modulating certain brain signals, offering an alternative to traditional hormone-based therapies13.

The MHRA decision was based on positive efficacy and safety results from three Phase III OASIS clinical trials, where elinzanetant met all primary endpoints and demonstrated a favorable safety profile23.

Bayer's Lynkuet emerges as a direct competitor to Astellas' hot flash drug and is seen as a potential growth driver for Bayer’s pharmaceutical division25.

This approval provides new hormone-free treatment options for physicians and women experiencing disruptive menopausal symptoms, with the potential to improve quality of life34.

Lynkuet is currently under regulatory review in other major markets, including the United States3.

Sources:

1. https://www.gov.uk/government/news/mhra-approves-elinzanetant-to-treat-moderate-to-severe-vasomotor-symptoms-hot-flushes-caused-by-menopause

2. https://firstwordpharma.com/story/5980639

3. https://www.bayer.com/media/en-us/bayer-receives-first-approval-worldwide-for-lynkuet-elinzanetant-in-the-uk-as-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/

4. https://pharmaphorum.com/news/bayer-bags-first-world-approval-hot-flush-therapy

5. https://insights.citeline.com/scrip/womens-health/bayer-bags-first-global-okay-for-hot-flashes-therapy-26CH3RICPRHSHAQHNV3WDLEHUY/