The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Elinzanetant for marketing authorization in the European Union for the treatment of moderate to severe vasomotor symptoms (VMS)—commonly known as hot flashes—linked to menopause or caused by adjuvant endocrine therapy (AET) in women with Breast cancer.
A final decision from the European Commission is expected in the coming months. If approved, elinzanetant would become the first dual neurokinin (NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) approved in the EU for both indications.
The therapy is already approved under the brand name Lynkuet in Australia, Canada, United Kingdom, and Switzerland for treating menopause-related VMS, with additional regulatory filings planned or underway globally. Currently, no approved treatment exists in the EU for menopause symptoms caused by endocrine therapy for breast cancer.
“Menopause is a truly individual experience, with symptoms and severity varying widely from woman to woman,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, and Member of the Pharmaceutical Leadership Team at Bayer. “The positive CHMP opinion for elinzanetant marks a significant step forward in broadening treatment options for women across Europe. This milestone reflects our ongoing commitment to advancing innovative solutions that support better health outcomes and empower healthcare providers to offer more tailored care to meet the distinct needs of each woman.”
The CHMP’s positive opinion is based on data from four Phase III studies—OASIS-1, OASIS-2, OASIS-3, and OASIS-4—which assessed the efficacy and safety of elinzanetant. The drug met all primary and key secondary endpoints across all trials and showed a favorable safety profile.
OASIS-1 and -2: Elinzanetant significantly reduced the frequency and severity of moderate to severe VMS at weeks 4 and 12 compared to placebo, with benefits maintained through week 26. It also improved sleep disturbances and menopause-related quality of life. Results were published in The Journal of the American Medical Association (JAMA) in August 2024.
OASIS-3: Confirmed sustained VMS reduction and safety over 52 weeks, with headache, fatigue, and somnolence as the most common side effects. Findings appeared in JAMA Internal Medicine in September 2025.
OASIS-4: Evaluated elinzanetant in women receiving endocrine therapy for Hormone receptor-positive breast cancer (HR+), showing significant VMS reduction, improved sleep and quality of life, and a consistent safety profile over 52 weeks. Data were published in The New England Journal of Medicine (NEJM) in June 2025.