Bayer (OTCPK:BAYRY) (OTCPK:BAYZF) said Tuesday it would seek marketing approval for its experimental menopause treatment, elinzanetant, after the drug was shown to reduce the frequency of hot flashes associated with menopause in a third late-stage trial.
Elinzanetant successfully met the primary endpoint in a Phase III OASIS 3 study, demonstrating 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 trial is overall consistent with previously conducted studies and published data on elinzanetant, Bayer said in a news release.
Elinzanetant is said to be the first dual neurokinin-1,3receptor 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 (NCT05030584) is the third Phase III study in the OASIS clinical development program with positive topline results. In early 2024, Bayer announced topline data of the first two Phase III studies OASIS 1 and 2 (NCT05042362 and NCT05099159) which met all primary and key secondary endpoints.
The company plans to submit the data from all three studies to health authorities for marketing approval of elinzanetant for the treatment of moderate-to-severe VMS associated with menopause.
