What Lynkuet is
Lynkuet (elinzanetant) is a non-hormonal prescription capsule for moderate to severe hot flashes and night sweats caused by menopause. The FDA approved it on October 24, 2025. It is made by Bayer and taken once daily at bedtime, with or without food.
It is the first and only drug that blocks both the neurokinin 1 and the neurokinin 3 receptor. That dual action is what distinguishes it from fezolinetant (Veozah), which blocks NK3 alone.
How it works
As estrogen falls, a cluster of neurons in the hypothalamus that helps regulate body temperature becomes overactive. These neurons signal partly through neurokinin B acting on the NK3 receptor. Blocking that receptor calms the misfiring thermostat, which is how this class reduces hot flashes without using hormones at all.
The NK1 receptor is involved in sleep regulation and mood pathways. Blocking it as well is the rationale for why elinzanetant was studied with sleep and not only flush count as an outcome.
How well it works
Approval rests on three phase 3 trials, OASIS 1, 2 and 3. In OASIS-3, elinzanetant reduced the frequency of moderate to severe vasomotor symptoms by more than 73% at 12 weeks, compared with 47% on placebo.
Read that placebo number rather than skipping it. Hot flashes respond substantially to placebo in almost every trial, which is why "it worked for my friend" is weak evidence in this particular symptom and why the controlled comparison matters.
Who it is for
The clearest candidates are women who cannot take estrogen or have decided not to:
- A history of breast cancer or another hormone-sensitive cancer
- A history of blood clots or stroke
- Active liver disease
- A personal preference against hormone therapy after an informed discussion
It treats vasomotor symptoms. It is not a substitute for estrogen's other effects — it does not protect bone density, and it does not treat genitourinary symptoms such as vaginal dryness or recurrent urinary tract infections. Women who need those addressed still need a separate conversation about local vaginal estrogen or another option.
Lynkuet compared with Veozah
| Lynkuet (elinzanetant) | Veozah (fezolinetant) | |
|---|---|---|
| Target | NK1 and NK3 receptors | NK3 receptor only |
| FDA approval | October 2025 | May 2023 |
| Dosing | Once daily at bedtime | Once daily |
| Liver monitoring | Required per label | Required; label updated after reports of serious liver injury |
Both carry liver-related monitoring requirements, and neither should be started without baseline liver testing and follow-up on the schedule the label specifies. This is the single most important practical difference between this drug class and an over-the-counter supplement, and it is the part most likely to be skipped.
What is not yet known
The trials ran to 52 weeks. Long-term safety beyond that, and use in women with a history of breast cancer specifically, are areas where the evidence base is still thin — the trials were not designed to answer those questions. Cost and insurance coverage in the first year after launch are also unsettled, and a new branded drug with no generic is rarely inexpensive.
The liver monitoring, concretely
Both drugs in this class require liver testing, and this is the part most likely to be skipped once a prescription is running smoothly. Expect baseline liver blood tests before starting and repeat testing on the schedule set out in the label during the early months of treatment.
Symptoms that should prompt a call rather than waiting for the next scheduled test: unusual tiredness with nausea, loss of appetite, pain in the upper right abdomen, dark urine, pale stools, or yellowing of the skin or eyes.
Side effects reported in the trials
The commonly reported effects in the OASIS programme were mild and included headache, tiredness and sleepiness — the last unsurprising for a drug taken at bedtime that also acts on sleep pathways. Liver enzyme elevations were the effect that drove the monitoring requirement.
Where it sits among the options
| Option | Hot flashes | Bone | Vaginal symptoms |
|---|---|---|---|
| Estrogen therapy | Yes | Yes | Yes (systemic or local) |
| Lynkuet / Veozah | Yes | No | No |
| SSRIs/SNRIs off-label | Partial | No | No |
| Local vaginal estrogen | No | No | Yes |
The table is the argument for why "non-hormonal option now exists" is not the same as "hormone therapy is no longer needed." A woman with hot flashes, thinning bone and vaginal dryness has three problems, and this drug addresses one of them.
Cost and access
It is a new branded drug with no generic. Expect prior authorisation requirements from most insurers in the first year, and expect the plan to ask what else has been tried. Manufacturer copay programmes usually exist for new launches and are worth asking about directly, as is the specific wording your prescriber uses in the authorisation request.
If it does not work
Give it the interval your prescriber specifies rather than a fortnight. If flushes remain unchanged after an adequate trial, the options are to reconsider hormone therapy if it was ruled out for reasons that can be revisited, to try the other drug in the class, or to look again at contributors that no drug fixes — alcohol, poor sleep, an untreated thyroid problem, or an anxiety disorder that is amplifying the experience of each flush.
