Bayer's Third Menopausal Relief Drug Trial Meets Primary Goal, German Conglomerate Seeks FDA Approval For Elinzanetant

Tuesday, Bayer AG BAYRY BAYZF announced topline results of the Phase 3 study OASIS 3 evaluating the efficacy and long-term safety of the investigational compound elinzanetant versus placebo. 

In this study, elinzanetant met the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 12 compared to placebo. 

The long-term safety profile observed over 52 weeks in the OASIS 3 study is consistent with previously conducted studies and published data on elinzanetant.

Elinzanetant is the first dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause, administered orally once daily.

OASIS 3 is the third Phase 3 study in the OASIS clinical development program. 

In early 2024, Bayer announced topline data of the first two Phase 3 studies OASIS 1 and 2.

Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to week 4 and 12 compared to placebo.

Both studies also achieved all three key secondary endpoints, showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo. 

Reuters highlighted that Bayer previously estimated the blood-thinning drug could have peak annual sales of more than €5 billion, and the menopause drug elinzanetant was given the potential of about a billion dollars or more per year.

Last year, Acer Therapeutics Inc’s ACER Phase 2a proof of concept clinical trial of ACER-801 (osanetant) as a potential treatment for moderate to severe VMS associated with menopause did not achieve statistical significance to decrease the frequency or severity of hot flashes in postmenopausal women.

Photo by ClareM via Shutterstock