Bayer reveals phase 3 trial success for menopause drug

Bayer's experimental drug, elinzanetant, has shown promising results in reducing the frequency and severity of hot flashes related to menopause through a series of phase 3 clinical trials. This non-hormonal treatment successfully hit all four primary endpoints in the OASIS 1 and 2 studies. These studies demonstrated that elinzanetant significantly reduces moderate to severe vasomotor symptoms (VMS) from baseline to weeks 4 and 12, when compared to a placebo.

Elinzanetant also met its key secondary goals, which included a notable decrease in VMS frequency as early as week 1 and improvements in sleep disturbances and menopause-related quality of life versus placebo. This compound acts as a dual neurokinin-1,3 (NK-1,3) receptor antagonist and is taken orally once daily. Its mechanism involves modulating estrogen-sensitive neurons in the hypothalamus. With decreased estrogen, these neurons become overactive, leading to impaired body heat regulation. By targeting these neurons, elinzanetant helps to normalize the thermoregulatory pathway, reducing hot flashes.

In March, Bayer shared positive topline results for the third phase 3 study, OASIS 3, which is part of the OASIS clinical development program. In this study, elinzanetant continued to show its effectiveness by reducing the frequency of hot flashes from baseline to week 12 in comparison to a placebo.

Bayer plans to submit the results from the three OASIS studies to regulatory bodies in the hope of gaining marketing approval. If approved, elinzanetant will enter the market to compete with Astellas' Veozah. Veozah, which is also a once-daily pill and a neurokinin 3 (NK3) receptor antagonist, received approval a year ago as the first non-hormonal treatment for moderate to severe VMS associated with menopause.

Overall, elinzanetant's success in clinical trials marks a significant step forward in offering non-hormonal treatment options for women suffering from menopause-related VMS.