# Elinzanetant

Source: https://onco.cc/drugs/elinzanetant/  
OnCo record `elinzanetant` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Lynkuet is a once-a-day capsule for moderate to severe hot flushes and night sweats. In Europe it is approved both for the menopause and for hot flushes caused by the hormone-blocking tablets taken after breast cancer treatment.

## Summary

Elinzanetant (Lynkuet; marketing authorisation holder Bayer AG) has been authorised in the EU since 17 November 2025 (CHMP opinion 18 September 2025) for the treatment of moderate to severe vasomotor symptoms. The EPAR overview says it is used for hot flushes and night sweats associated with menopause or caused by adjuvant endocrine therapy for breast cancer, the oestrogen-blocking treatment given after surgery or other cancer treatment to lower the chance of the cancer coming back. It is taken by mouth once a day at bedtime and is under additional monitoring. In the study of 474 women on adjuvant endocrine therapy that the EMA summarises (OASIS-4, NCT05587296), daily moderate to severe hot flushes fell by around 6 on elinzanetant against around 3 on placebo after 4 weeks, and by around 8 against around 4 after 12 weeks; the effect lasted at least 50 weeks, and sleep and quality of life also improved more than on placebo.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-11-03
- Also known as: elinzanetant; Lynkuet
- Tags: universe-gap; ema-register; supportive
- Brand: Lynkuet
- Modality: Small-molecule neurokinin receptor antagonist (oral capsule)
- Mechanism: Blocks neurokinin B from attaching to two of its receptors in the brain. Neurokinin B and oestrogen together regulate the brain's temperature control centre; when oestrogen falls during menopause or endocrine therapy the balance is lost and hot flushes follow (EPAR overview, EMA).
- Approvals: EU 2025: Moderate to severe vasomotor symptoms, including those caused by adjuvant endocrine therapy for breast cancer (EPAR overview)

## Sources

- EMA: Lynkuet (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/lynkuet

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- technologies: [Endocrine therapy (SERMs, AIs, SERDs)](https://onco.cc/technologies/endocrine-therapy/), [Menopause brought on by cancer treatment, and the options for it](https://onco.cc/technologies/menopause-after-cancer-treatment/)
- companies: [Bayer](https://onco.cc/companies/bayer/)
- trials: [A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer](https://onco.cc/trials/nct05587296/)
- key papers: [Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer](https://onco.cc/key-papers/paper-nct05587296-n-engl-j-med-2025/)

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JSON: https://onco.cc/api/v1/entities/elinzanetant.json