FDA approves elinzanetant (Lynkuet) for vasomotor menopausal symptoms

The FDA has approved elinzanetant 60 mg capsules (Lynkuet; Bayer) for the treatment of moderate to severe hot flashes due to menopause, according to an announcement by Bayer.¹

Announced on October 24, 2025, the decision is based on data from the phase 3 OASIS program and, according to Bayer, makes elinzanetant the first and only FDA-approved dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist.

"Today's approval of elinzanetant is a significant advance for women's health," said James A. Simon, MD, CCD, MSCP, IF, FACOG, clinical professor of Obstetrics and Gynecology at the George Washington University in Washington, DC. "It's a new option among other options for the treatment of vasomotor symptoms due to menopause—an option that has rapid onset, beneficial effects, very few side effects, and no significant adverse effects as seen with other therapies. It appears to have no adverse effect, for example, on weight or sexual function."

The approval follows positive safety and efficacy data for elinzanetant observed in the OASIS-3 trial.² In the trial, participants receiving elinzanetant reported an over 73% reduction in symptom frequency and severity by week 12, from 6.7 episodes per day to 1.6. In comparison, patients receiving placebo reported a decline from 6.8 to 3.4 per day.

“So, the positive outcomes that were observed in the 52-week trial were consistent with those published in the earlier studies, OASIS-1 and 2,” said JoAnn Pinkerton, MD, a professor of obstetrics and gynecology at the University of Virginia.² “So it really contributes to the robustness of the findings and demonstrated both the sustained benefit and the safety of elinzanetant in a much broader population of women."

Addressing the need for nonhormonal VMS treatments

According to Pinkerton, up to 80% of postmenopausal women experience vasomotor menopausal symptoms (VMS), with persistent symptoms reported by 1 in 3. These symptoms often adversely impact home life, work, and overall well-being. This highlights the need for effective non-hormonal options in patients with contraindications to estrogen-based therapies.²

Patients in the OASIS-3 trial underwent a 52-week program, taking either elinzanetant 120 mg or a matching placebo once per day orally.³ Follow-up visits occurred every 4 weeks until week 12, then every 6 weeks until week 42. At week 52, patients attended an end-of-treatment visit.

VMS outcomes were recorded using an electronic hot flash diary. Additionally, patients completed the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form and Menopause-Specific Quality Of Life (MENQOL) questionnaire, alongside reporting adverse events (AEs).³

Sustained benefit and safety

Overall, the decline of moderate to severe VMS event frequency in patients taking elinzanetant was -73.8% by week 12, vs -47% in those taking placebo. For symptom severity, mean changes were -1.2 and -0.8, respectively.³

Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form scores declined by –9.4 and –5.7, respectively, by week 12, while MENQOL scores declined by -1.3 and -1.1, respectively, by week 50. Treatment-emergent AEs were reported in 70% of patients receiving elinzanetant vs 61.1% receiving placebo.³

For serious treatment-emergent AEs, rates were 4.2% and 1.9%, respectively. However, none of these events were considered treatment-related, highlighting the overall safety and efficacy of elinzanetant toward reducing moderate to severe VMS among postmenopausal women.³

Expanding research for broader populations

“What is so exciting is that with elinzanetant, we potentially have a new treatment option that can be used first line for moderate to severe hot flashes, whether due to menopause or breast cancer endocrine therapy,” said Pinkerton.³

Future research about elinzanetant includes the OASIS-4 trial assessing its safety and efficacy in women with breast cancer or at high risk receiving endocrine therapy.² Significant positive safety and efficacy have been indicated in this population by early findings.

Elinzanetant is also being assessed in postmenopausal women with sleep disturbances in the NIRVANA trial. With the FDA approval, it is the third non-hormonal therapy approved for managing menopausal symptoms, providing relief for patients with VMS.²

References

1. Bayer. Bayer’s Lynkuet® (elinzanetant), the First and Only Neurokinin 1 and Neurokinin 3 Receptor Antagonist, Receives FDA Approval for Moderate to Severe Hot Flashes Due to Menopause. Bayer.com. Published October 24, 2025. Accessed October 24, 2025. https://www.bayer.com/en/us/news-stories/lynkuet
2. Pinkerton JV. JoAnn Pinkerton, MD, highlights long-term safety and efficacy of elinzanetant. Contemporary OB/GYN. September 28, 2025. Accessed October 23, 2025. https://www.contemporaryobgyn.net/view/joann-pinkerton-md-highlights-long-term-safety-and-efficacy-of-elinzanetant.
3. Krewson C. OASIS-3 highlights safety and efficacy of elinzanetant against VMS. Contemporary OB/GYN. September 23, 2025. Accessed October 23, 2025. https://www.contemporaryobgyn.net/view/oasis-3-highlights-safety-and-efficacy-of-elinzanetant-against-vms.