FDA
New nonhormonal therapy approved for menopausal hot flashes
Brand name: Lynkuet
Generic name: elinzanetant
Manufacturer: Bayer Healthcare Pharmaceuticals
Approval date: October 24, 2025
FDA approved Lynkuet (elinzanetant), a dual neurokinin 1 (NK1) and neurokinin 3 (NK3) inhibitor, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause.
Efficacy
Efficacy of Lynkuet was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 (NCT05042362) and OASIS 2 (NCT05099159), in 796 menopausal women. Co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes.
Compared with placebo, elinzanetant significantly reduced the frequency of moderate to severe vasomotor symptoms at week 4 (-3.29 and -3.04 in OASIS 1 and 2, respectively, both P<0.0001) and at week 12 (-3.22 and -3.24, both P<0.0001).
Safety
The safety of Lynkuet was evaluated in three randomized, double-blind, placebo-controlled, multicenter clinical trials (OASIS 1, OASIS 2 and OASIS 3 [NCT05030584]) in 1,420 women. In OASIS 3, a total of 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety.
The most frequently reported (≥5%) adverse reactions were headache, fatigue, dizziness, and somnolence.
Lynkuet may cause CNS depression, and patients should be advised to avoid activities requiring mental alertness until they know how the drug affects them. It can lead to elevated liver enzymes (ALT/AST), so hepatic function should be monitored before and during treatment, with discontinuation recommended for significant elevations. Use is contraindicated during pregnancy due to potential fetal harm, and caution is advised in patients with a history of seizure disorders due to a possible increased risk of seizures.
Recommended dose
The recommended dosage of Lynkuet is 120 mg (two 60-mg capsules) orally once daily at bedtime at about the same time each day.
Sources:
Lynkuet (elinzanetant) [package insert]. Food and Drug Administration. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/219469s000lbl.pdf Revised October 2025. Accessed October 27, 2025.
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. [News release]. 2025. https://www.bayer.com/en/us/news-stories/lynkuet