MHRA approves Bayer’s Lynkuet as first non-hormonal treatment for menopause hot flushes

The United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the world’s first marketing authorisation for elinzanetant, a non-hormonal oral treatment developed by Bayer AG (ETR: BAYN), for moderate to severe vasomotor symptoms—commonly referred to as hot flushes—associated with menopause. Marketed as Lynkuet, the once-daily oral tablet is now the first approved drug in its class offering relief from menopause-related symptoms without involving hormone replacement therapy (HRT).

The approval is expected to reshape the therapeutic landscape for women unable or unwilling to use hormone-based options, with institutional sentiment viewing it as a long-awaited intervention in an underserved global market. Analysts suggest the decision not only validates Bayer’s neuroscience and women’s health pipeline but may also set a regulatory precedent for other health agencies worldwide.

The U.K. approval was granted under the Access Consortium’s New Active Substance Work-Sharing Initiative (NASWSI), a regulatory pathway designed to speed up multinational drug evaluations. Bayer has indicated plans to pursue global submissions, including a future filing with the U.S. Food and Drug Administration and Health Canada, where Lynkuet is under active consideration.

How does elinzanetant work to address the underlying neurobiology of menopausal hot flushes and night sweats?

Unlike hormone replacement therapies that restore estrogen systemically, elinzanetant targets neurokinin-1 and neurokinin-3 receptors in the brain—key regulators in the hypothalamus that become hyperactive as estrogen levels decline. This overactivity disrupts the body’s thermoregulation, triggering hot flushes, night sweats, and sleep disturbances.

By blocking these pathways, elinzanetant modulates the brain’s heat-regulating function, helping restore balance without altering hormonal profiles. This mechanism also addresses downstream effects like fragmented sleep—an area of increasing interest among researchers and payers aiming to quantify menopause’s impact on quality of life and work productivity.

Bayer’s formulation is a 120 mg daily oral tablet designed for chronic use over several months. The approval includes labelling guidance for general practitioners and gynecologists, who will be advised to assess symptom severity and patient contraindications before prescribing.

What clinical trial results from the OASIS program supported Lynkuet’s approval by the MHRA?

The MHRA decision was based on extensive data from the OASIS clinical trial programme, which enrolled over 1,400 women aged 40 to 65 across multiple geographies. The pivotal trials—OASIS 1, 2, and 3—evaluated the efficacy and safety of daily 120 mg elinzanetant versus placebo over treatment periods of up to 52 weeks.

Participants receiving elinzanetant showed a statistically significant reduction in the frequency and severity of hot flushes beginning as early as week four. By week 12, the average number of daily hot flushes was reduced by approximately 3.5 episodes from baseline, compared to 2.0 in the placebo group. Night sweats, measured via patient-reported outcome tools, also declined markedly, with meaningful improvements observed in sleep quality indices.

The longer-term extension study, OASIS 3, demonstrated sustained symptom reduction and a favorable safety profile over one year. Reported adverse events were generally mild to moderate, with headache, fatigue, and gastrointestinal discomfort being the most common. Importantly, no clinically relevant elevations in liver enzymes or adverse effects on endometrial thickness were reported, distinguishing elinzanetant from certain prior neurokinin-targeting compounds.

What does Bayer’s strategy around Lynkuet signal about its broader pipeline focus in women’s health?

The approval of elinzanetant represents a strategic milestone in Bayer’s broader repositioning as a leader in non-hormonal women’s health. Historically associated with contraceptives and fertility treatments, Bayer’s pipeline has expanded into areas such as menopause, uterine fibroids, and endometriosis through both internal development and licensing partnerships.

With Lynkuet, Bayer now enters a category with high clinical need and low market competition. The pharmaceutical developer has confirmed it will launch Lynkuet initially via private prescription in the United Kingdom, followed by formal submission to the National Institute for Health and Care Excellence (NICE) for potential inclusion in NHS formularies.

Beyond the U.K., Bayer’s development plan includes seeking additional approvals in Canada, Australia, Switzerland, and the United States. According to executive statements in previous earnings calls, the drugmaker sees the menopausal care segment as a long-term growth pillar, particularly as aging demographics and rising awareness expand the eligible patient base.

How has investor sentiment and financial market response evolved following the MHRA authorisation?

While Bayer AG shares (ETR: BAYN) did not post an immediate spike post-announcement, institutional investors have signaled cautious optimism regarding the long-term revenue potential of Lynkuet. Market watchers noted that non-hormonal menopause therapies represent a white space with significant upside—especially if reimbursement is secured in public healthcare systems and awareness campaigns reach underserved populations.

Analysts expect global peak sales potential for elinzanetant to exceed €500 million annually by 2030, contingent on FDA approval and successful commercialization in North America. Bayer’s broader women’s health unit has been under institutional scrutiny in recent quarters, and the MHRA’s endorsement is expected to improve visibility on future pipeline monetization.

What are the commercial access plans and future outlook for elinzanetant across global markets?

With the MHRA green light in hand, Bayer is now expected to roll out Lynkuet through private clinics and specialists in the U.K., while preparing health technology assessments for NICE review. According to internal sources familiar with the company’s roadmap, Bayer intends to prioritize high-income markets with mature healthcare systems for its initial wave of expansion.

Regulatory filings in the United States and Europe are expected within the next 12 to 18 months, with Health Canada already reviewing the compound under parallel procedures. Additionally, Bayer has initiated discussions with oncologists to explore elinzanetant’s potential in breast cancer survivors experiencing therapy-induced vasomotor symptoms—an indication likely to be pursued under separate trials and labelling.

In the long run, Bayer may also face competitive challenges as rival pharmaceutical developers enter the neurokinin receptor modulation space. However, with the first regulatory approval secured and safety data spanning one year, Lynkuet has secured a first-mover advantage that could translate into early market leadership.

What safety monitoring systems are in place and what can patients expect from real-world use?

Patients prescribed Lynkuet can expect symptom improvements—including reduced hot flushes and better sleep—within four to eight weeks, based on trial outcomes. The MHRA has issued guidance to healthcare providers on monitoring side effects, and the drug is now listed under the Yellow Card Scheme for ongoing pharmacovigilance.

Bayer has committed to transparent post-marketing surveillance and periodic safety updates, in line with MHRA obligations. Physicians will be advised to screen patients for underlying neurological or hepatic conditions and to discontinue treatment if any adverse events exceed acceptable thresholds.

As with all new medicines, the success of elinzanetant in real-world settings will depend on adherence, patient education, and effective adverse event reporting. Bayer is expected to support launch efforts with digital education tools, professional outreach, and potentially, direct-to-consumer campaigns once additional regulatory approvals are obtained.

How does MHRA’s decision shape the global regulatory and innovation outlook for menopause care?

The MHRA’s landmark decision positions the United Kingdom as a pioneer in menopausal care innovation, establishing a benchmark that other regulators may follow. The agency’s willingness to act on robust non-hormonal clinical data could accelerate similar submissions across the Access Consortium and beyond.

Experts suggest that the growing demand for menopause support—coupled with social and workplace conversations around women’s health equity—will drive broader market formation. Bayer’s success may prompt further investment in neurokinin-based and alternative therapies from both established drugmakers and emerging biotech firms.

For patients and clinicians, Lynkuet offers a new chapter in evidence-backed, non-hormonal symptom relief, anchored in neuroscience and long-term safety. Its impact on care standards, payer policy, and women’s health R&D will likely ripple across the industry well into the next decade.