Elinzanetant VMS update: As Positive Results Pile Up, Bayer Readies for Menopause Treatment’s Future

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This could be a big year for Bayer’s elinzanetant, and for patients dealing with vasomotor symptoms (VMS), known colloquially as menopause hot flashes.

Coming off three positive readouts of their OASIS 1-3 studies in 2024, and the announcement last week that OASIS 4 results met primary and secondary endpoints, demonstrating statistically significant reductions in the frequency of moderate to severe VMS compared to placebo. Elinzanetant also reduced the severity of VMS and improved sleep disturbances and quality of life, Bayer said in a January 14, 2025, news release.¹

The US Food and Drug Administration is expected to complete its review of elinzanetant in the summer, with a Prescription Drug User Fee Act target date for July 26, 2025. Bayer said they are prepping their launch plan as they await word from regulatory authorities.¹

“With regulatory submissions under review around the world, Bayer anticipates a potential launch this year, aiming for fast market penetration building on Bayer's strength in women's healthcare,” the news release reads. “Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist with potential to transform the management of menopause, broadening treatment choices, and addressing major unmet needs in women’s health.”¹

According to the recently released results from OASIS 4, elinzanetant significantly reduced the frequency and severity of moderate to severe VMS in women receiving adjuvant endocrine therapy for hormone receptor–positive breast cancer or who are at high risk for the disease. Statistically significant reductions in VMS frequency emerged by week 1 of treatment and were maintained through week 52. Improvements in VMS severity, sleep disturbances, and menopause-related quality of life were also reported, and the safety profile was consistent with previous studies.²

Bayer said findings from OASIS 4 extend the favorable results observed in prior trials from the OASIS program and underscore an unmet need for non-hormonal therapies in women for whom long-term endocrine therapy is indicated. The company plans to present detailed results from OASIS 4 at an upcoming scientific congress.¹

References

1. Bayer’s pharma growth strategy progressing well as pipeline advances [news release]. Bayer. Published January 14, 2025. Accessed January 15, 2025. https://www.bayer.com/media/en-us/bayers-pharma-growth-strategy-progressing-well-as-pipeline-advances/
2. Elinzanetant Meets All Endpoints in Phase 3 Study of VMS Caused by Adjuvant Endocrine Therapy for Breast Cancer. Patient Care Online. Published January 9, 2025. Accessed January 15, 2025. https://www.patientcareonline.com/view/elinzanetant-meets-all-endpoints-in-phase-3-study-of-vms-caused-by-adjuvant-endocrine-therapy-for-breast-cancer