Elinzanetant FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 14, 2024.
FDA Approved: No
Generic name: elinzanetant
Company: Bayer HealthCare Pharmaceuticals Inc.
Treatment for: Hot Flashes, Menopausal Disorders
Elinzanetant is a dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in development for the treatment of moderate-to-severe vasomotor symptoms associated with menopause.
- Vasomotor symptoms (VMS), or hot flashes, commonly occur in women experiencing menopause due to a decrease in estrogen levels.
- Elinzanetant is a dual NK-1 and 3 receptor antagonist that is thought to work in VMS associated with menopause by modulating a group of estrogen sensitive KNDy neurons in the hypothalamus region of the brain. When estrogen levels are decreased, the KNDy neurons become hypertrophic which leads to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms.
- The New Drug Application submission for elinzanetant is based on positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of elinzanetant versus placebo. Findings showed that elinzanetant (120 mg orally once daily) significantly reduced the frequency and severity of moderate-to-severe VMS and demonstrated a favorable safety profile.
Development timeline for elinzanetant
Further information
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