FDA approves elinzanetant (Lynkuet), a dual NK1/NK3 blocker for hot flashes
The FDA approved Bayer’s elinzanetant, a once-nightly non-hormonal capsule for moderate to severe hot flashes and night sweats caused by menopause.
EVIDENCE:
Phase 3 RCTs
WHY IT MATTERS
It gives women who cannot or prefer not to use hormones a second neurokinin-targeting option, and its trials also measured improvements in sleep disturbance, one of the most common complaints of midlife.
Approval was based on the OASIS 1, 2 and 3 trials. In OASIS 1 and 2, elinzanetant 120 mg reduced the frequency and severity of hot flashes versus placebo through 12 weeks and improved sleep disturbance scores. OASIS 3, a 52-week trial, showed the effect was sustained over a year.
The most common side effects were headache, fatigue, dizziness and sleepiness. Because it can depress the central nervous system, people are advised not to drive or operate machinery until they know how it affects them. It joins fezolinetant (Veozah), approved in 2023, as a non-hormonal option.
PRIMARY SOURCE
LYNKUET U.S. prescribing information, October 2025; Pinkerton JV et al., JAMA 2024 (OASIS 1 and 2)
OASIS 1 · OASIS 2 · OASIS 3
Educational summary reviewed by Farhan Tahir, MD. Not individual medical advice. Medicines named here require a prescription and medical supervision.
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FDA approves elinzanetant (Lynkuet), a dual NK1/NK3 blocker for hot flashes
The FDA approved Bayer’s elinzanetant, a once-nightly non-hormonal capsule for moderate to severe hot flashes and night sweats caused by menopause.
Phase 3 RCTs
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