Bayer's Lynkuet Gains FDA Approval, Expanding Options for Menopausal Hot Flash Treatment

The U.S. Food and Drug Administration (FDA) has approved Bayer's Lynkuet (elinzanetant) for the treatment of moderate to severe hot flashes in menopausal women, marking a significant advancement in non-hormonal therapies for vasomotor symptoms. This approval, announced on October 27, 2025, introduces a novel dual-action medication to the limited arsenal of treatments for one of the most common and disruptive symptoms of menopause.

A New Approach to Menopausal Symptom Management

Lynkuet represents a breakthrough in menopausal care as the first FDA-approved therapy that targets both neurokinin 1 (NK1) and neurokinin 3 (NK3) receptors. This dual-action mechanism is designed to regulate body temperature more effectively, addressing the root cause of hot flashes without the use of hormones.

The drug's approval is based on robust clinical data from Bayer's Phase III OASIS development program. In the OASIS 1 and OASIS 2 trials, Lynkuet demonstrated significant reductions in vasomotor symptoms (VMS) frequency and severity. Patients experienced a 55.9% reduction in VMS after 4 weeks and a 65.2% reduction at week 12 in OASIS 1, with similar results observed in OASIS 2.

Dr. JoAnn Pinkerton, a lead investigator and professor of obstetrics and gynecology at the University of Virginia Health System, highlighted the drug's rapid efficacy: "We saw a very rapid reduction in hot flashes and night sweats similar to [Veozah], and an improvement in the severity of the hot flashes, as well as an improvement in health-related quality of life and sleep."

Market Implications and Patient Access

Lynkuet's entry into the U.S. market, scheduled for November 2025, is poised to challenge Astellas Pharma's Veozah, which was approved in May 2023. Both drugs target neurokinin receptors, but Lynkuet's dual NK1 and NK3 targeting may offer potential advantages.

Bayer has set the wholesale acquisition cost for Lynkuet at $625 for a 30-day supply, with actual pricing varying based on insurance coverage. To enhance accessibility, Bayer has partnered with digital pharmacy BlinkRx to provide the drug at a lower cost to eligible patients.

Christine Roth, Bayer's executive vice president of global product strategy and commercialization, emphasized the drug's significance: "There is a need for more individualized approaches to menopause care, and Lynkuet addresses a significant gap in treatment options."

Safety Profile and Clinical Considerations

While Lynkuet's approval expands treatment options, healthcare providers and patients must consider its safety profile. Common side effects include headache, fatigue, dizziness, and drowsiness. The drug's label notes potential risks such as daytime impairments, increased liver blood test values, and possible pregnancy loss.

Notably, Lynkuet does not carry a black box warning for liver damage, unlike its competitor Veozah. This distinction may influence prescribing patterns and patient preferences in the growing market for non-hormonal menopause treatments.

As the global population of menopausal women is projected to reach 1.2 billion by 2030, with 47 million women entering menopause annually, Lynkuet's approval represents a timely addition to the treatment landscape. It offers a new option for the estimated 80% of women who experience hot flashes during the menopausal transition, potentially improving quality of life for millions.