For more on the path to FDA approval for elinzanetant, see:
Elinzanetant Data to Feature Prominently at Congress of the European Society of Gynecology: Bayer Update
Elinzanetant, a first in class dual neurokinin-1 and 3 (NK-1,3) receptor antagonist in late-stage clinical development, has a US PDUFA date set for July 26, 2025.
Bayer will present findings from its phase 3 clinical development program for elinzanetant at the 16th Congress of the European Society of Gynecology (ESG) in Riga, Latvia, being held April 1-5, 2025, according to a company announcement this morning. The data include analyses on the drug’s impact on vasomotor symptoms (VMS) and sleep disturbances, which significantly affect the quality of life for women experiencing menopause.
Elinzanetant is a first-in-class dual neurokinin-1 and 3 (NK-1,3) receptor antagonist in late-stage clinical development. The nonhormonal therapy is designed for the treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. Administered orally once daily, the drug modulates estrogen-sensitive KNDy neurons in the hypothalamus, which are implicated in the dysregulation of thermoregulatory pathways leading to VMS.
The US FDA is expected to complete its review of the new drug application (NDA) for elinzanetant Bayer submitted to the agency in October 2024 in anticipation of a Prescription Drug User Fee Act date of July 26, 2025.
Positive data from the phase 3 OASIS development program form the foundation supporting the 2024 NDA. The phase 3 trials have demonstrated the efficacy of elinzanetant in reducing VMS frequency and severity and also in improving sleep disturbances associated with menopause. Results from the OASIS 1 and 2 trials were published in JAMA2 in August 2024. The OASIS 3 study, presented at The Menopause Society’s annual meeting in September 2024, provided additional long-term efficacy and safety data over 52 weeks. The OASIS 4 trial, assessing the efficacy of elinzanetant in managing VMS caused by adjuvant endocrine therapy for breast cancer, has also reported positive topline results, including treatment effect as early as week 1 that were sustained over the 52-week study period. Further details expected at upcoming conferences, according to Bayer.
Bayer’s presentations at ESG 2025 include:
- Oral Presentation
- Associations between Vasomotor Symptoms, Sleep Disturbances, and Frequent Mood Changes in Menopausal Women: Analysis of Data from the Study of Women's Health Across the Nation – Carina Dinkel-Keuthage
- Poster Presentations
- Sleep disturbance in menopausal women with vasomotor symptoms: findings from two Phase 3 studies – Cecilia Caetano
- Effect of elinzanetant for the treatment of vasomotor symptoms associated with menopause: pooled data from two Phase 3 studies – Nick Panay
- EMPOWER: Evaluating Menopausal symPtom treatment Options and WomEns’ pReferences – Cecilia Caetano
- Does sleep disturbance have an impact on depression and anxiety in perimenopausal and postmenopausal women? A Europe-based survey – Carina Dinkel-Keuthage
- Effect of elinzanetant for the treatment of vasomotor symptoms associated with menopause across BMI and smoking history subgroups: pooled data from two Phase 3 studies – Rosella E. Nappi
- Effect of elinzanetant for the treatment of vasomotor symptoms associated with menopause across race and ethnicity subgroups: pooled data from two Phase 3 studies – Rosella E. Nappi
These presentations highlight elinzanetant’s potential to address the unmet needs of menopausal women by offering a non-hormonal treatment alternative that targets the underlying neurobiology of VMS and related sleep disturbances. Submissions for regulatory approval are currently ongoing in the US, EU, and other global markets.
References
1. Bayer to present research on late-stage compound elinzanetant and impact on menopause symptoms at ESG 2025. News release. Bayer. March 13, 2025. Accessed March 13, 2025. https://www.bayer.com/media/en-us/bayer-to-present-research-on-late-stage-compound-elinzanetant-and-impact-on-menopause-symptoms-at-esg-2025/
2. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618
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