Elinzanetant Reduces Frequency, Severity of VMS in Differing Female Populations

This content was independently produced by Pharmacy Times in partnership with Bayer Healthcare.

When treating women across different populations, 120 mg of elinzanetant (Bayer Healthcare) reduced the frequency and severity of moderate-to-severe vasomotor symptoms (VMS), according to an analysis presented at The Menopause Society’s 2025 Annual Meeting.

These data, which synthesize findings from 4 phase 3 clinical trials, suggest elinzanetant has a consistent efficacy across populations, including women with a lower baseline symptom burden and those with endocrine therapy-induced VMS.¹

Elinzanetant is a dual neurokinin-targeted therapy that reduces VMS—also known as hot flashes—across different populations of women. The treatment is approved under the brand name Lynkuet in the UK and Canada but has yet to be approved in the United States. In July 2025, the FDA announced that it needed additional time to fully review the new drug application submission. Concerns regarding the general approvability were not raised by the FDA, reported Bayer Healthcare in a news release.²

The OASIS Clinical Trials

The analysis assessed efficacy data from 4 multicenter, double-blind, placebo-controlled, randomized phase 3 clinical trials: OASIS-1 (NCT05042362)³, OASIS-2 (NCT05099159)⁴, and OASIS-3 (NCT05030584)⁵, which included naturally- or surgically-induced postmenopausal women aged 40 to 65 years experiencing moderate to severe VMS associated with menopause; and OASIS-4 (NCT05587296)⁶, which enrolled women aged 18 to 70 years receiving endocrine therapy for HR+ breast cancer experiencing 35 or more moderate to severe VMS per week. OASIS-1 and OASIS-2 required at least 50 moderate to severe VMS per week, whereas OASIS-3 did not have a minimum frequency threshold for inclusion in the study.^1,3-6

A total of 396, 400, 628, and 474 women were enrolled in OASIS-1, OASIS-2, OASIS-3, and OASIS-4, respectively. All participants were randomly assigned to receive 120 mg of elinzanetant or a matching placebo during the first 12 weeks. Across all 4 trials, mean (95% CI) daily moderate to severe VMS frequency and severity and Patient-Reported Outcomes Measurement Information System Disturbance Short Form (PROMIS SD SF) 8b total T-scores were evaluated at baseline and week 12.^1,3-6

Results

OASIS-1 and OASIS-2

The OASIS-1 and OASIS-2 elinzanetant group had a baseline mean VMS per 24 hours of about 13.4 and 14.7, respectively, compared with 14.3 and 16.2 in the placebo groups. Baseline VMS severities were 2.6 and 2.5 (OASIS-1) and 2.5 and 2.5 (OASIS-2) in these respective groups. Elinzanetant was shown to significantly reduce VMS frequency more than placebo at weeks 4 (OASIS-1: −3.3 [95% CI, −4.5 to −2.1], P < .001; OASIS 2: −3.0 [95% CI, −4.4 to −1.7], P < .001) and 12 (OASIS 1: −3.2 [95% CI, −4.8 to −1.6], P < .001; OASIS 2: −3.2 [95% CI, −4.6 to −1.9], P < .001). Elinzanetant also improved VMS severity compared with placebo at weeks 4 (OASIS 1: −0.3 [95% CI, −0.4 to −0.2], P < .001; OASIS 2: −0.2 [95 CI, −0.3 to −0.1], P < .001) and 12 (OASIS 1: −0.4 [95% CI, −0.5 to −0.3], P < .001; OASIS 2: −0.3 [95% CI, −0.4 to −0.1], P < .001). Generally, elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable, wrote the authors.^1,7

OASIS-3

Expanding upon the 26-week findings from OASIS-1 and OASIS-2, OASIS-3 showed that, at week 12 of the trial, the mean change from baseline in daily moderate to severe VMS frequency was −5.4 (95% CI, −6.3 to −4.5) for elinzanetant and −3.5 (95% CI, −4.1 to −2.9) for placebo. Additionally, elinzanetant was shown to improve VMS frequency and severity over 50 weeks, and sleep disturbances and menopause-related quality of life over 52 weeks. Regarding safety, elinzanetant was not associated with hepatotoxic effects, endometrial hyperplasia, or meaningful changes in bone density or bone turnover markers, wrote the authors.

Treatment-related adverse events (AEs) were more common with elinzanetant than placebo (30.4% vs 14.6%), of which the most common were somnolence, fatigue, and headache.^1,8

OASIS-4

At baseline, the mean daily frequency of moderate to severe VMS was about 11.4 episodes (95% CI, 10.7 to 12.2) in the elinzanetant group and 11.5 episodes (95% CI, 10.5 to 12.5) in the placebo-elinzanetant group. At week 4, the mean change from baseline in the mean daily frequency of moderate to severe VMS was −6.5 episodes (95% CI, −7.2 to −5.8) among those who were receiving elinzanetant and −3.0 episodes (95% CI, −3.9 to −2.2) among those who were receiving placebo (difference: −3.5 episodes [95% CI, −4.4 to −2.6]; P < .001). Additionally, at week 12, the mean change was −7.8 episodes (95% CI, −8.5 to −7.1) among participants receiving elinzanetant and −4.2 episodes (95% CI, −5.2 to −3.2) for placebo (difference: −3.4 episodes [95% CI, −4.2 to −2.5]; P < .001).^1,9

Regarding AEs, a total of 220 participants (69.8%) receiving elinzanetant and 98 (62.0%) receiving placebo reported at least 1 AE that occurred while receiving treatment during weeks 1 through 12, with the most common being headache, fatigue, and somnolence. Serious AEs occurred during weeks 1 through 12 in 8 participants (2.5%) receiving elinzanetant and 1 participant (0.6%) receiving placebo.^1,9

Future Directions

Across all 4 OASIS trials, larger mean changes from baseline to week 12 were consistently observed in daily moderate to severe VMS frequency and severity in addition to PROMIS SD SF 8b total T-score in women who received 120 mg of elinzanetant compared with placebo. These results, according to the investigators suggest consistent efficacy across differing populations of women, including those with a lower baseline VMS symptom burden (OASIS-3) and those with VMS caused by endocrine therapy for the treatment of breast cancer (OASIS-4).¹

“We are confident in the potential of elinzanetant to provide meaningful clinical benefit to women pending regulatory approval. We continue to work with the FDA to make this treatment available for women in menopause with moderate to severe hot flashes,” Yesmean Wahdan, MD, senior vice president and head of medical affairs, North America, Pharmaceuticals, Bayer Healthcare, said in a news release. “Despite the universal experience of menopause, social stigma and misinformation persist, leaving many women to suffer without treatment and support. It’s critical we advance innovation and education in menopause so women can work with their health care provider to determine the best option for them.”²

REFERENCES

1. Panay N, Cardoso F, Simon JA, et al. S-21 – Efficacy of elinzanetant 120 mg across different populations of women from four phase 3 OASIS studies. Presented at: The Menopause Society Annual Meeting; Orlando, Florida. October 21–25, 2025.

2. Bayer. Bayer Provides Regulatory Update on Elinzanetant for the Treatment of Moderate to Severe Hot Flashes Due to Menopause. News release. July 25, 2025. Accessed October 20, 2025. https://www.bayer.com/en/us/news-stories/regulatory-update-on-elinzanetant

3. A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-1). ClincialTrials.gov identifier: NCT05042362. Updated June 27, 2024. Accessed October 20, 2025. https://clinicaltrials.gov/study/NCT05042362

4. A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 26 Weeks in Women Who Have Been Through the Menopause (OASIS-2). ClinicalTrials.gov identifier: NCT05099159. Updated May 29, 2024. Accessed October 20, 2025. https://clinicaltrials.gov/study/NCT05099159

5. A Study to Learn More About How Well Elinzanetant Works and How Safe it is for the Treatment of Vasomotor Symptoms (Hot Flashes) That Are Caused by Hormonal Changes Over 52 Weeks in Women Who Have Been Through the Menopause (OASIS-3). ClinicalTrials.gov identifier: NCT05030584. Updated March 15, 2025. Accessed October 20, 2025. https://clinicaltrials.gov/study/NCT05030584

6. A Study to Learn More About How Well Elinzanetant Works and How Safe it is Compared to Placebo for the Treatment of Hot Flashes Caused by Anti-cancer Therapy in Women With, or at High Risk for Developing Hormone-receptor Positive Breast Cancer (OASIS-4). ClinicalTrials.gov identifier: NCT05587296. Updated June 24, 2025. Accessed October 20, 2025. https://clinicaltrials.gov/study/NCT05587296

7. 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

8. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Intern Med. Published online September 08, 2025. doi:10.1001/jamainternmed.2025.4421

9. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. N Engl J Med. 2025;393(8):753-763. doi:10.1056/NEJMoa2415566