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VMS and Menopause

Atopic Dermatitis Provider Toolkit

Adult Immunization Provider Toolkit

Dermatology Hot Topics

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Warfarin-Induced Skin Necrosis


These 2 patients presented with a swollen hand and rapidly proximally progressive edema secondary to a bite.

These 2 patients presented with a swollen hand and rapidly proximally progressive edema secondary to a bite. What creature did the biting?

Swollen Hands-What’s Biting?

A 66-year-old woman had a mildly pruritic rash on the buttocks, lower back, abdomen, and upper posterior thighs. The eruption had been present for approximately 18 months.

A 66-year-old woman had a mildly pruritic rash on the buttocks, lower back, abdomen, and upper posterior thighs. The eruption had been present for approximately 18 months. Your diagnosis?

Clinical Topics

“Swimsuit Area” Rash: Your Dx?

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma.

A 67-year-old woman noted the appearance of several non-tender, rock-hard, purple-colored nodules on her legs. Her medical history was significant for distant non-Hodgkin lymphoma. The violaceous color and configuration of the skin lesions suggests which of the following? 

Hard Purple Nodules: Your Dx?

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted the first global marketing authorization for elinzanetant, a dual neurokinin-1 and neurokinin-3 receptor antagonist, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with 

The drug will be marketed under the brand name Lynkuet™ in the UK. The US FDA set a Prescription Drug User Fee Act date for July 26, 2026, after accepting Bayer's New Drug Application in October 2024.

Elinzanetant is the first dual-action, nonhormonal therapy in its class to receive regulatory approval for menopausal VMS, which affects up to 80% of women during the menopausal transition. Despite the high prevalence, nearly two-thirds of symptomatic women remain untreated, according to Bayer.

The UK approval is based on results from Bayer’s Phase III OASIS clinical development program, comprising 3 pivotal studies (OASIS-1, -2, and -3). Across all 3 trials, elinzanetant met primary efficacy endpoints and showed a favorable safety profile.

Elinzanetant significantly reduced the mean frequency and severity of moderate to severe VMS at weeks 4 and 12 compared with placebo.

At week 26, more than 80% of participants in the elinzanetant arm achieved at least a

, including those who switched from placebo after week 12.

The treatment also led to statistically significant improvements in sleep disturbance and menopause-related quality of life.

Secondary endpoints were met, including a reduction in VMS frequency as early as week 1.

Elinzanetant demonstrated a statistically significant reduction in moderate to severe VMS frequency by week 12, sustained over 52 weeks.

The most commonly reported adverse events were headache, fatigue, and somnolence.

“I welcome expanded therapeutic options that address the diverse needs and preferences of women going through menopause," Paula Briggs, MBChB, a consultant gynecologist in sexual and reproductive health in Liverpool Women’s NHS Foundation Trust and immediate past chair of the British Menopause Society, said in a press release. "Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans, helping women manage their symptoms and potentially enhance their overall quality of life during this important transition.”

Bayer reported that regulatory submissions for elinzanetant are underway in the US, European Union, and additional markets.

Bayer receives first approval worldwide for Lynkuet™ (elinzanetant) in the UK as treatment of moderate to severe vasomotor symptoms associated with menopause. News release. Bayer. July 10, 2025. Accessed July 11, 2025. 

https://www.bayer.com/media/en-us/bayer-receives-first-approval-worldwide-for-lynkuet-elinzanetant-in-the-uk-as-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/

Halsey G. Elinzanetant Update: FDA Accepts Bayer NDA, Sets July 2025 PDUFA Date. 

https://www.patientcareonline.com/view/elinzanetant-update-fda-accepts-bayer-nda-sets-july-2025-pdufa-date

Halsey G. Elinzanetant meets safety, efficacy endpoints in phase 3 studies of menopausal VMS. 

https://www.patientcareonline.com/view/elinzanetant-meets-safety-efficacy-endpoints-in-phase-3-studies-of-menopausal-vms

Jennings S. Topline phase 3 data released for elinzanetant efficacy for moderate-to-severe VMS. 

https://www.patientcareonline.com/view/topline-phase-3-data-released-for-elinzanetant-efficacy-for-moderate-to-severe-vms

Bayer's elinzanetant gains UK approval as the first dual-action, nonhormonal treatment for menopausal symptoms.

Elinzanetant Gets UK Nod for Moderate to Severe Vasomotor Symptoms in Menopause: Is the US Far Behind?

 above are of the anterior and posterior trunk of 16-year-old male who visits his primary care physician for an annual physical. His trunk is scattered with numerous asymmetric papular lesions with indistinct borders and variegated color; many are >6mm in diameter. Close-ups of several areas shown in 

The teen presents for an annual physical. You note asymmetric papular lesions that cover his trunk. What is your  diagnosis? 

Multiple Nevi on a Young Man 

Five days after a 41-year-old man started taking a new medication, this superficial but painful lesion appeared on his neck. It slowly resolved after the drug was stopped and a topical corticosteroid was applied twice daily.

Five days after starting a new medication, this lesion appeared on a man’s neck. It slowly resolved after the drug was stopped. Which of these drugs do you suspect might have caused the lesion?

Round Red Patch on a Man's Neck

Tate De Leon, MD

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