Elinzanetant Under FDA Review: A Potential New Non-Hormonal Option for Menopausal Symptoms

What Happened

Bayer’s elinzanetant (brand name Lynkuet) is a new, non-hormonal therapy designed to reduce moderate to severe hot flashes in menopausal women. The drug works by targeting NK-1 and NK-3 receptors, which play a role in regulating body temperature and vasomotor symptoms.

Late-stage clinical trials have shown promising results, with participants reporting meaningful reductions in hot flash frequency and severity.

Currently, the FDA has extended its review of elinzanetant by up to 90 days. This administrative extension does not suggest safety concerns; it is part of the normal review process for new medications.

Why It Matters

For many women, hormone therapy (HT) is not an option due to health risks, personal preference, or contraindications. Elinzanetant represents another non-hormonal approach to managing hot flashes, adding to the growing range of treatment options.

This potential therapy is especially significant because non-hormonal alternatives have historically been limited and less effective, leaving many women without satisfactory relief.

What This Means for Women in Perimenopause & Menopause

If approved, elinzanetant could offer relief to women who:

Cannot take estrogen-based treatments due to medical contraindications.
Prefer a non-hormonal solution.
Struggle with disruptive hot flashes that interfere with sleep, work, or daily life.

While the drug is still under review, it’s important for women to stay informed about emerging options and discuss symptom management with their healthcare providers.

Access & Availability

U.S.: Under FDA review; approval decision pending.
International: No approvals yet; future regulatory filings may follow depending on FDA outcome.

Benefits & Risks

Potential Benefits

Reduction in frequency and severity of hot flashes.
Non-hormonal mechanism, suitable for women who cannot use hormone therapy.
May improve sleep quality and overall quality of life.

Potential Risks / Considerations

Long-term safety data is limited since it is a new medication.
Possible side effects will be clarified once FDA review is complete and labeling is finalized.

Next Steps / What to Watch For

FDA decision expected after the extended review period.
Monitoring of trial data and post-approval safety will guide real-world use.
If approved, doctors will begin integrating elinzanetant into non-hormonal menopause treatment strategies.

What This Means for Your Midlife Health

Elinzanetant represents a hopeful step forward for women seeking safe, effective, non-hormonal solutions for hot flashes. While still under review, staying informed allows women to make empowered choices about future treatment options.