This week, Bayer announced results from its phase 3 OASIS 3 trial, confirming the efficacy and long-term safety of elinzanetant for treating vasomotor symptoms (VMS) associated with menopause.
The trial showed that elinzanetant significantly reduced the frequency of moderate to severe hot flashes over 12 weeks compared to placebo, with sustained improvements in sleep disturbances and quality of life observed over 52 weeks. These results build on earlier positive findings from the OASIS 1 and 2 studies.
The OASIS 3 study involved 628 postmenopausal women and confirmed that elinzanetant met its primary and secondary endpoints, showing a reduction in VMS symptoms without the safety concerns typically associated with hormone treatments. The safety profile was consistent with prior studies, with no signs of liver toxicity or endometrial malignancies.
Elinzanetant is the first dual neurokinin-1 and 3 receptor antagonist in late-stage clinical development for non-hormonal treatment of VMS. The compound offers a new, once-daily oral option for managing menopause-related symptoms without the risks tied to hormone replacement therapy.
Based on the successful outcomes of OASIS 1, 2, and 3, Bayer has submitted a new drug application to the U.S. FDA for elinzanetant, with additional marketing authorization applications submitted to health authorities worldwide.
If approved, elinzanetant will join Astellas' Veozah in the menopause symptoms space. Astellas won approval for the once-daily pill, a neurokinin 3 (NK3) receptor antagonist, a year ago. Veozah was the first non-hormonal treatment for moderate to severe vasomotor symptoms associated with menopause.
