FDA Extends Review Period for Elinzanetant NDA for Menopausal Vasomotor Symptoms

The US FDA has extended its review of Bayer’s New Drug Application (NDA) for elinzanetant, a first-in-class dual neurokinin-1 and neurokinin-3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, Bayer announced today.1

According to the company, the PDUFA date has been extended by up to 90 days to allow the FDA additional time to complete its review of the NDA and supporting information. The FDA did not raise any concerns regarding the general approvability of elinzanetant in its communication.1

“With the consistent positive results from our clinical Phase III program assessing the efficacy and safety of elinzanetant, we remain confident about elinzanetant’s potential as a new treatment option for moderate to severe vasomotor symptoms associated with menopause,” Christian Rommel, PhD, executive committee member of Bayer’s Pharmaceuticals Division and Global Head of Research and Development, said in a press release today.1

The NDA for elinzanetant is supported by data from 3 pivotal phase 3 clinical trials—OASIS-1, OASIS-2, and OASIS-3—which evaluated the efficacy and safety of elinzanetant versus placebo in women experiencing moderate to severe VMS.1

• OASIS-1 and OASIS-2 demonstrated statistically significant reductions in VMS frequency and severity compared with placebo, with results published in JAMA in August 2024.2
• OASIS-3 provided confirmatory long-term safety and efficacy data and was presented at The Menopause Society annual meeting in September 2024.

Elinzanetant was recently approved in the United Kingdom and Canada under the brand name Lynkuet™.3 Regulatory submissions are also under review in the European Union and other international markets.1

If approved by the FDA, elinzanetant would be the first dual-action nonhormonal therapy in its class available in the US for the treatment of menopausal VMS, a condition affecting up to 80% of women during the menopausal transition.1

We will have more on this developing story as more information is released.

References:

1. Bayer provides regulatory update on elinzanetant in the U.S. News release. Bayer. July 25, 2025. Accessed July 25, 2025. https://www.bayer.com/media/en-us/bayer-provides-regulatory-update-on-elinzanetant-in-the-us/
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. Published online August 22, 2024. doi:10.1001/jama.2024.14618
3. Jennings S. Elinzanetant Gets UK Nod for Moderate to Severe Vasomotor Symptoms in Menopause: Is the US Far Behind? Patient Care Online. July 11, 2025. https://www.patientcareonline.com/view/elinzanetant-gets-ema-nod-for-moderate-to-severe-vasomotor-symptoms-in-menopause-is-the-us-far-behind-