Overview
- Lynkuet (elinzanetant) won FDA clearance for moderate-to-severe vasomotor symptoms, with U.S. availability expected in November 2025.
- Trial data in more than 2,000 participants showed rapid symptom relief within weeks and about a 55% reduction in hot-flash frequency at 12 weeks, with improved sleep and severity scores.
- The drug blocks neurokinin receptors NK1 and NK3 involved in thermoregulation, differing from Veozah (fezolinetant), which targets only NK3.
- Safety findings include fatigue, headache and drowsiness, plus transient liver-enzyme elevations that prompted FDA guidance for baseline and three‑month blood tests and continued post‑market surveillance; no serious liver injuries were reported in studies up to one year.
- A study in women with hormone receptor–positive breast cancer on endocrine therapy found fewer hot flashes and better sleep versus placebo, offering a nonhormonal option as longer-term safety is evaluated.
- Lynkuet’s wholesale list price is about $625 for a 30‑day supply, with Bayer offering savings programs and a BlinkRx partnership to reduce out‑of‑pocket costs for eligible patients.