FDA Accepts NDA for Menopause Drug, Elinzanetant

hot flash woman © MarLei - stock.adobe.com

Bayer announced today that the FDA has accepted their new drug application (NDA) for menopause drug, elinzanetant, to treat moderate to severe menopausal vasomotor symptoms, according to details published in a news release. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late development for menopause relief. The Prescription Drug User Fee Act (PDUFA) date is July 26, 2025, according to a Bayer representative.

Elinzanetant is a once daily 120 mg pill formulated to treat vasomotor symptoms, also known as hot flashes. During menopause, decreased estrogen levels cause the body’s “thermostat,” or hypothalamus to become extra sensitive. When the hypothalamus thinks the body is too warm, it starts a chain reaction in the form of a hot flash to cool the body down. Elinzanetant decreases hot flashes by modulating estrogen sensitive neurons in the hypothalamus.

The NDA acceptance is based on positive data from three phase 3 OASIS studies, which demonstrated efficacy. Hot flash frequency and severity was measured using an electronic hot flash diary.

OASIS 1 and 2 studied the effects of elinzanetant in nearly 400 women ages 40 to 65 over 26 weeks across 15 countries. By week 4, 62.8% of participants in OASIS 1 and 62.2% of participants in OASIS 2 reported a decrease in hot flash severity. Full results were published in JAMA Network in August.

OASIS 3 extended the treatment window to 52 weeks. Details were presented at The Menopause Society Annual Meeting last month.

OASIS 4 is an expansion of the phase three program and will investigate the efficacy of elinzanetant for women experiencing hot flashes because of endocrine therapy or breast cancer prevention, not menopause.

“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency," Christine Roth, executive vice president of Global Product Strategy and Commercialization and member of the Pharmaceutical Leadership Team at Bayer, said in the news release.

In addition to the OASIS trials, Bayer is conducting NIRVANA, a phase 2, double blind study exploring the use of elinzanetant to treat sleep disturbances associated with menopause. Approximately 69% of women experience sleep disturbances during menopause. Difficulty falling or staying asleep can be attributed to hot flashes or changes in mood, specifically depression.

About 47 million women enter menopause every year. Up to 80% of menopausal women report having hot flashes which are one of the top medical concerns for women during this period. Severe symptoms can last up to 10 years after a woman’s last menstrual cycle.