Treatment class · Labels read August 15, 2026

Non-hormonal menopause treatment: the two approved drugs, compared label to label

Name: Non-hormonal menopause treatment: Veozah and Lynkuet compared, label to label
Creator: Iacob Pastina

Hormone therapy is still the most effective treatment for hot flashes. The Menopause Society's 2023 nonhormone therapy position statement says so in its own words: Hormone therapy remains the most effective treatment for vasomotor symptoms and should be considered in menopausal women within 10 years of their final menstrual periods. These drugs exist for the women who cannot take estrogen, or who have decided not to. There are two of them with an FDA indication: Veozah (fezolinetant), one 45 mg tablet daily, a boxed warning for liver injury, $566 a month list, and 5 follow-up liver draws inside nine months. And Lynkuet (elinzanetant), 120 mg at bedtime, no boxed warning, 1 follow-up draw, a seizure warning the 08/2026 label revision widened to cover every patient, and no published US price. No trial has compared the two.

By Iacob Pastina. Every figure here is read from a primary source: the two FDA labels on DailyMed, the approval records on Drugs@FDA, the published trials on PubMed, and the Menopause Society statement itself.

This is general information, not medical advice. Both drugs on this page are prescription medicines with required bloodwork. Which one suits you, and whether either does, is a decision for you and a licensed clinician.

Veozah and Lynkuet, side by side

Every cell below comes from one of the two FDA labels or from the approval record behind it. Where a manufacturer publishes no figure, the cell says so instead of borrowing one from an aggregator.

Veozah and Lynkuet compared on their FDA labels
On the label	Veozah (fezolinetant)	Lynkuet (elinzanetant)
Maker	Astellas	Bayer
FDA approval	May 12, 2023Type 1 New Molecular Entity, priority review. Application 216578.	October 24, 2025Type 1 New Molecular Entity, standard review. Application 219469.
Class	Neurokinin 3 (NK3) receptor antagonist	Neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist
Dose	One 45 mg tablet	120 mg, taken as two 60 mg capsules, swallowed whole
Timing	Once daily, with or without food	Once daily at bedtime
Boxed warning	Yes. Hepatotoxicity, added December 16, 2024.	None. 4 Warnings and Precautions instead, one of which the 08/2026 revision widened.
Follow-up liver draws	5 after the baseline panelMonth 1, Month 2, Month 3, Month 6, Month 9	1 after the baseline panelMonth 3
Key contraindications	Known cirrhosis. Severe renal impairment or end-stage renal disease. Concomitant use of a CYP1A2 inhibitor.	Pregnancy. The label states that exposure to LYNKUET may cause pregnancy loss or stillbirth..
Week 12 against placebo	Trial 1: -2.6 a day95% CI -3.4 to -1.7, p<0.001 Trial 2: -2.5 a day95% CI -3.6 to -1.5, p<0.001	OASIS 1: -3.22 a day95% CI -4.81 to -1.63, p<0.0001 OASIS 2: -3.24 a day95% CI -4.6 to -1.88, p<0.0001
Published US list price	$566.00 per 30-day supplyPublished by Astellas, with average out of pocket by coverage type on the same page.	None reachable.Bayer publishes no US list price reachable from the open web.

Week-12 figures are least-squares mean differences against placebo in moderate to severe vasomotor symptoms per 24 hours, from each label's Clinical Studies section. Baselines differ between the two programmes, which is the reason these columns cannot be read against each other. See the next section.

No trial has compared these two drugs

No randomised trial has compared fezolinetant against elinzanetant. Every head-to-head claim about this class is indirect. That is the first thing any comparison of this class has to say, and almost none of them do.

The reason it matters is visible in the table above. The placebo arms in the Veozah trials started at 10.5 and 11.6 hot flashes a day. The placebo arms in the Lynkuet trials started at 14.26 and 16.16. Those are different populations recruited under different protocols, and the placebo arms themselves improved by 37% to 43% depending on which trial you pick. Lining the two drug columns up against each other compares the trials as much as it compares the drugs.

The one formal comparison, and who paid for it

Matching-adjusted indirect comparison, published in Maturitas 2026 Feb;205:108782 (PMID 41418588). What it found:

Comparable efficacy on vasomotor symptom frequency and severity.
Sleep disturbance improved more with elinzanetant.
That sleep difference did not translate into a significant MENQOL difference.

The disclosure that belongs beside it: Five of the eleven authors are Astellas employees and the analysis vendor was contracted by Astellas. Astellas makes fezolinetant. That does not make the analysis wrong, and it does mean the only formal comparison of these two drugs was paid for by one of them.

One more piece of housekeeping, because it explains an absence. A 2025 paper in Obstetrics and Gynecology that circulates in this comparison is under an active Expression of Concern published by the journal in March 2026. We are not citing it while the journal is telling readers not to rely on it.

The monitoring burden is the difference you will live with

Both labels open the same way: a hepatic panel before the first dose, and the same starting gate of ALT or AST at or above 2 times the upper limit of normal, or total bilirubin at or above 2 times ULN. What happens after that diverges hard.

Veozah

follow-up draws

follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment.

Lynkuet

follow-up draws

3 months after initiation of therapy.

Counting the baseline panel, that is 6 lab appointments in nine months against 2. Each of the 4 extra visits is a copay or a cash lab fee and a result somebody has to chase down. It is the most concrete difference between these two drugs, and it is the one that decides whether a woman is still on treatment in month six.

It also sets a floor on what a telehealth intake can honestly do here. Neither drug can be prescribed off a questionnaire alone, because somebody has to order and read a liver panel before the first dose. If a platform offers you either one without labs, that is the question to ask.

What the guideline recommends, and what it recommends against

The Menopause Society 2023 nonhormone therapy position statement, Menopause 30(6):573-590. The full lists are below with the evidence level attached to each item, because the level is what separates a considered no from an absence of data.

Recommended

Cognitive behavioral therapyLevel I
Clinical hypnosisLevel I
SSRIs and SNRIsLevel I
GabapentinLevel I
FezolinetantLevel I
OxybutyninLevels I-II
Weight lossLevels II-III
Stellate ganglion blockLevels II-III

Not recommended

Paced respirationLevel I
Supplements and herbal remediesLevels I-II
Cooling techniquesLevel II
Avoiding triggersLevel II
ExerciseLevel II
YogaLevel II
MindfulnessLevel II
RelaxationLevel II
SuvorexantLevel II
Soy foodsLevel II
Soy extractsLevel II
EquolLevel II
CannabinoidsLevel II
AcupunctureLevel II
Calibration of neural oscillationsLevel II
ChiropracticLevels I-III
ClonidineLevels I-III
Dietary modificationLevel III
PregabalinLevel III

Read the date before you read the lists

Accepted March 21, 2023, before Veozah was approved and more than two years before Lynkuet was. It recommends fezolinetant at Level I. Elinzanetant is named in its text as a drug then in development, and it carries no recommendation and no evidence level in the recommendations table, so nothing in it endorses Lynkuet. Anyone telling you the Menopause Society backs Lynkuet is turning a mention of a drug then in development into a recommendation the statement never made.

The statement itself, as published, accepted March 21, 2023.

The not-recommended column is the part worth reading twice. Exercise, yoga, mindfulness, cooling techniques and avoiding triggers all sit at Level II against vasomotor symptoms specifically, which is the same evidence tier the statement uses elsewhere to say yes. Those things are good for other reasons. The statement is saying they do not fix hot flashes.

Brisdelle carries a boxed warning of its own

Brisdelle (paroxetine 7.5 mg) was approved June 28, 2013 under application 204516, dosed at 7.5 mg once daily at bedtime. The only SSRI carrying an FDA indication for vasomotor symptoms, and it carries a boxed warning of its own. Its boxed warning is headed: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS.

It gets recommended as the gentler route around Veozah's liver warning, usually by pages that do not print the sentence above. Both drugs carry a boxed warning. They warn about entirely different things, and the choice between them is a clinical conversation rather than a search for the option without a black box.

Brisdelle prescribing information, DailyMed and the Drugs@FDA application record.

Who each of these is actually for

You have no contraindication to estrogen

Hormone therapy is the more effective route by the guideline's own words, it has no required liver panel, and it is cheaper on our verified numbers. The cheapest all-in monthly price on the 13women's-wing platforms we verify is Alloy at $40/mo, Transparency Grade A, medication included. Start at the scored rankings, the price-sorted table, or estradiol by delivery form.

A clinician has ruled estrogen out, your liver is healthy, and you can make the lab appointments

Veozah is the one you can price in advance, which matters more than it sounds when a drug lists at $566 a month. Astellas publishes average out of pocket by coverage type and runs a savings program for commercially insured patients that excludes Medicare and Medicaid. The cost of entry is the monitoring: 6 lab visits in nine months, and a boxed warning that exists because liver injury appeared after approval.

Estrogen is out and the lab schedule is the thing that will break you

Lynkuet asks for one follow-up draw instead of 5 and has no boxed warning. Three things to weigh against that. It is dosed at bedtime because of a daytime-impairment warning, with a driving-simulator finding behind it. Its seizure warning was widened in the 08/2026 label revision, from women with a seizure history to everyone on the drug. And Bayer publishes no US price you can check before you fill it.

You want to try something without a prescription first

The guideline recommends cognitive behavioral therapy and clinical hypnosis at Level I, and both are non-drug. It recommends against supplements and herbal remedies at Levels I to II. That is a considered no with evidence behind it, and it is the opposite of what the supplement aisle implies. The full list, with the evidence level attached to every entry, is in the two columns above.

Two more pages sit next to this one. Veozah alternatives covers what is in the development pipeline and what the trade coverage got wrong about it. If you are weighing hormone therapy and want the side-effect rates with the placebo column beside them, the estradiol patch label rates and the progesterone rates are transcribed from the labels.

FAQ

Non-hormonal treatment, answered

What are the non-hormonal options for menopause hot flashes?

Two prescription drugs carry an FDA indication for moderate to severe vasomotor symptoms due to menopause: Veozah (fezolinetant), a neurokinin 3 receptor antagonist from Astellas, and Lynkuet (elinzanetant), a neurokinin 1 and 3 receptor antagonist from Bayer. Brisdelle (paroxetine 7.5 mg) is the only SSRI with an FDA indication for the same symptoms. Beyond the approved drugs, the Menopause Society's 2023 nonhormone therapy position statement recommends cognitive behavioral therapy, clinical hypnosis, SSRIs and SNRIs, gabapentin and fezolinetant at Level I, and oxybutynin at Levels I to II. It recommends against supplements and herbal remedies at Levels I to II.

Is Lynkuet better than Veozah?

No randomised trial has compared them, so no evidence answers that question directly. The only formal comparison is a matching-adjusted indirect comparison published in Maturitas 2026 Feb;205:108782, which found comparable efficacy on vasomotor symptom frequency and severity, greater improvement in sleep disturbance with elinzanetant, and no significant MENQOL difference. Five of its eleven authors are Astellas employees and the analysis vendor was contracted by Astellas, and Astellas makes fezolinetant. What the two labels let you compare directly is burden: Lynkuet has no boxed warning and 1 follow-up liver draw, Veozah has a boxed warning for hepatotoxicity and 5 follow-up draws inside nine months. Lynkuet carries a longer warning list, including a seizure warning that the 08/2026 label revision widened from patients with a seizure history to patients generally.

Is Veozah better than HRT?

The 2023 Menopause Society nonhormone therapy position statement says hormone therapy remains the most effective treatment for vasomotor symptoms and should be considered in menopausal women within 10 years of their final menstrual periods. The same statement recommends fezolinetant at Level I, so Veozah is a recommended option, positioned for women who cannot or will not take estrogen. On cost, Veozah lists at $566 a month while the cheapest all-in hormone therapy subscription we verify is $40/mo with the medication included. On monitoring, Veozah requires a baseline hepatic panel plus 5 follow-up draws in the first nine months and hormone therapy labels carry no equivalent requirement.

Do supplements work for hot flashes?

The Menopause Society's 2023 position statement recommends against supplements and herbal remedies for vasomotor symptoms at Levels I to II, and against soy foods, soy extracts, equol and cannabinoids at Level II. Those are the same evidence levels it uses to recommend cognitive behavioral therapy and gabapentin in the other direction, so this is a considered negative rather than an absence of data. Nothing sold over the counter for hot flashes carries an FDA indication for them.

Does Brisdelle have a boxed warning?

Yes. Brisdelle (paroxetine 7.5 mg), approved June 28, 2013 under application 204516, carries a boxed warning headed "WARNING: SUICIDAL THOUGHTS AND BEHAVIORS". It is the only SSRI with an FDA indication for vasomotor symptoms, dosed at 7.5 mg once daily at bedtime. It is frequently offered as the milder alternative to Veozah's boxed warning for liver injury, and the pages that frame it that way tend not to mention that it has a boxed warning of its own.

Sources

Percentages quoted anywhere on this page: Calculated from the label's own baseline count and least-squares mean change. Neither the label nor the published trial reports a percentage. The FDA announcements behind the two approvals and the Veozah boxed warning are the source of record for those dates. They are named rather than linked, because www.fda.gov returns a 404 to automated clients. Both approvals and the labeling supplement are visible on the Drugs@FDA application records linked above.

This is general information, not medical advice. Both drugs on this page are prescription medicines with required baseline bloodwork, and hormone therapy is a prescription decision too. Talk to a licensed clinician before starting, stopping or changing any treatment. Reviewed by Iacob Pastina.