FDA extends review period for Bayer’s elinzanetant for vasomotor symptoms

FDA extends review period for Bayer’s elinzanetant for vasomotor symptoms | Image credit: Contemporary OB/GYN

Menopause patients may have to wait a little longer for another treatment for vasomotor symptoms due in part to the FDA’s recent decision to extend the review period for Bayer’s elinzanetant, the first neurokinin 1 and neurokinin 3 receptor antagonist for the treatment of vasomotor symptoms in menopause.

The July 25, 2025, announcement from Bayer stated the FDA needed additional time, up to 90 days, to review the full new drug application submission (NDA), which included data to support the submission. “The FDA did not raise any concern regarding the general approvability of elinzanetant in its correspondence,” according to a company press release.

The NDA submission was supported by positive data from 3 phase 3 studies, OASIS 1, 2, and 3, which investigated the safety and efficacy of elinzanetant vs placebo.

Read about the latest data here: Elinzanetant displays positive phase 3 safety and efficacy data against VMS

“With the consistent positive results from our clinical phase 3 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”, said Christian Rommel, PhD, member of the Executive Committee of Bayer’s Pharmaceuticals Division and Global Head of Research and Development. “As we continue to work with the FDA during the ongoing review, we are fully committed to making elinzanetant available to women in the U.S. as soon as we receive FDA approval.”

Elinzanetant was recently approved for the treatment of mild to moderate vasomotor symptoms associated with menopause in the United Kingdom and Canada under the brand name Lynkuet.

Reference:

Bayer. Bayer provides regulatory update on elinzanetant in the U.S. Bayer provides regulatory update on elinzanetant in the U.S. Bayer. July 25, 2025. Accessed July 25, 2025.