The medicine, marketed as Lynkuet, received EU marketing authorisation on November 17, 2025
Irish hospitals contributed to the international trial supporting elinzanetant, a non-hormonal treatment now authorised across the European Union for moderate-to-severe hot flushes and night sweats, including those caused by endocrine therapy for breast cancer.
The medicine, marketed as Lynkuet, received EU marketing authorisation on November 17, 2025. It blocks both neurokinin-1 and neurokinin-3 receptors and is taken orally at bedtime.
St Vincent’s University Hospital and the Mater Misericordiae University Hospital participated in OASIS-4, a phase III trial involving 474 women across 90 centres in 16 countries. UCD’s Prof Donal Brennan was among the authors of the findings, published in the New England Journal of Medicine.
Participants were receiving endocrine treatment for hormone receptor-positive breast cancer or its prevention. At week four, moderate-to-severe vasomotor symptoms fell by an average of 6.5 episodes daily with elinzanetant, compared with 3.0 with placebo. At week 12, the reductions were 7.8 and 4.2 episodes respectively.
Sleep disturbance and menopause-related quality of life also improved. The study was funded by Bayer.
The findings offer an additional approach to a difficult clinical problem: controlling troublesome symptoms without adding oestrogen during hormone-sensitive breast cancer treatment. Reported adverse effects included fatigue, somnolence and diarrhoea. The evidence concerns symptom relief, rather than an improvement in cancer survival.
The EU authorisation covers both menopause-associated symptoms and those linked to adjuvant endocrine therapy. However, EU approval does not automatically secure HSE reimbursement, which requires a separate Irish funding decision.