1 August 2024 - The new drug application includes data from the Phase 3 studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo.
Bayer today announced that a new drug application for the investigational compound elinzanetant has been submitted to the US FDA for the treatment of moderate to severe vasomotor symptoms associated with menopause.