James Simon, MD, Genevieve Neal-Perry, MD, highlight elinzanetant's impact and safety

With its FDA approval on October 24, 2025, Bayer's elinzanetant has ushered in a big advancement for women's health for the treatment of moderate to severe hot flashes because of vasomotor symptoms associated with menopause. Elinzanetant was approved based on the phase 3 OASIS-3 trial, where participants receiving the treatment reported an over 73% reduction in symptom frequency and severity by week 12.¹

It has been a welcome addition since its approval. How are patients responding?

“Based on my experience with elinzanetant and my patients, they're responding very well and very similar to what we saw in the trial, and that is that there is a quick onset of treatment in terms of reduction of hot flashes, and for people who have sleep disruption, they're sleeping better,” said Genevieve Neal-Perry, MD, PhD, of the University of North Carolina School of Medicine, Chapel Hill, during an interview conducted at the 2026 American College of Obstetricians & Gynecologists (ACOG) Annual Clinical & Scientific Meeting.²

“When patients present to me with complaints of vasomotor symptoms, we do a very detailed history, so we understand what the risks are for hormonal therapy, as well as whether there are any things that may make non-hormonal therapies not a good choice.”

But what about safety? Recently, at the 2026 ACOG meeting in Washington, D,C., James Simon, MD, Reproductive endocrinologist; Infertility specialist; George Washington University; IntimMedicine Specialists, Washington, D.C., was part of a pooled safety analysis of elinzanetant across four placebo-controlled trials.³

“In doing [these trials], the sample size became fairly large, and the duration of treatment also was extended largely because 1 of those 4 studies was an entire year-long study duration,” said Simon.

“The results of the study demonstrated no new or different and or unanticipated side effects or adverse events and reinforced the current labeling for the product in and of itself. The number one side effect or adverse event that we reported in this series of four trials was actually headache.”

Given that across the studies less than 10% of treated study participants, Simon said “where the non-treated, that is to say placebo subjects, had about 7% reported headaches, namely a very low side effect profile for this expanded data set… I think we can say that the FDA was correct in allowing this product to get to market, and it certainly fulfills that high safety bar with no new surprises based on this study.”

References:

1. Krewson C. FDA approves elinzanetant (Lynkuet) for vasomotor menopausal symptoms. Contemporary OB/GYN. Published October 24, 2025. Accessed June 23, 2026. https://www.contemporaryobgyn.net/view/fda-approves-elinzanetant-lynkuet-for-vasomotor-menopausal-symptoms
2. ACOG. Contemporary OB/GYN. Accessed June 23, 2026. https://www.contemporaryobgyn.net/conferences/acog
3. Simon J, Yeager B, Kauitz AM, et al. Pooled Safety of Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause Across the US Population From 4 Placebo-Controlled Studies. Session. Presented at: American College of Obstetricians & Gynecologists Annual Clinical & Scientific Meeting. May 1-3, 2026. Washington, D.C.