Positive topline results from phase III long-term study OASIS 3 support submissions for marketing authorization of elinzanetant

In this study, elinzanetant successfully met the primary endpoint 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 study is overall consistent with previously conducted studies and published data1, on elinzanetant.

“OASIS 3 was designed to address the important question of the long-term profile of elinzanetant. With the positive topline results of OASIS 3 adding to the existing evidence from OASIS 1 and 2, elinzanetant has consistently shown positive data across all Phase III clinical trials in the treatment of moderate to severe VMS associated with menopause,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “We are looking forward to sharing the full data at upcoming medical conferences as we move towards submitting to health authorities.”

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.

“It is critical that we continue to broaden therapeutic options that will effectively meet the significant needs of menopausal women,” said Nick Panay, Principal Investigator for OASIS 3, Consultant Gynaecologist, Imperial College Healthcare NHS Trust, Professor of Practice, Imperial College London and President of International Menopause Society. “These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms.”

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 results of all three studies will be presented at upcoming scientific congresses. Bayer will submit the data from the OASIS 1, 2 and 3 studies to health authorities for approval of marketing authorizations of elinzanetant for the treatment of moderate to severe VMS associated with menopause.