The FDA granted approval to elinzanetant, a nonhormonal agent shown in multi‑national trials to reduce vasomotor symptoms of menopause, including hot flashes and night sweats. Regulatory documents and trial publications cited significant symptom reduction versus placebo across the pivotal studies, and the approval follows detailed safety reviews from the agency. Clinical investigators and trial sponsors emphasized the drug’s nonhormonal mechanism as an alternative for patients who cannot or choose not to take estrogen. The company plans to roll out the product into women’s-health channels and said physician education will focus on positioning versus hormonal therapies.
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