Veozah (Fezolinetant): The New Non-Hormonal Hot Flash Medication
Dr. Karla Loken is a board-certified OB/GYN with over two decades of clinical experience and a distinguished career driving innovation in women's health across the pharmaceutical, diagnostics, and medical device industries. Through her consultancy, Loken & Associates, Dr. Loken provides medical affairs expertise and fractional Chief Medical Officer (CMO) services, helping early-stage companies bridge the gap between scientific innovation and industry application. She serves as Chief Medical Officer to MenoHealth. · 15 min read · Sep 2026
Medically reviewed by Karla F. Loken, DO, FACOOG on September 20, 2026
Veozah (fezolinetant) is a new non-hormonal hot flash medication. How it works, what SKYLIGHT trial data shows, who it fits, and the FDA liver warning.
The WHI unnecessarily frightened women and left them suffering with very real symptoms, possibly preventing them from taking a life-changing, even life-prolonging treatment. HRT can have beneficial impacts on bones, brains, and heart — and many common fears around hormone therapy are not supported by the latest scientific evidence.
Veozah (fezolinetant) is the first medication of its kind: a non-hormonal prescription drug that targets the brain pathway that actually generates hot flushes, rather than working around the symptom. It was approved by the FDA in May 2023 for moderate-to-severe vasomotor symptoms (hot flushes and night sweats) associated with menopause. For many women who can’t or won’t take hormone therapy, it’s the most significant treatment option to emerge in two decades.
This guide walks through how Veozah works, what the clinical trial data actually shows, who it’s for and who it isn’t, and what to expect from the conversation with a clinician about it.
Key takeaways
Veozah (fezolinetant) is a non-hormonal NK3-receptor antagonist FDA-approved in May 2023 for moderate-to-severe hot flushes and night sweats.
In the SKYLIGHT phase 3 trials, fezolinetant reduced vasomotor symptom frequency by about 60% at 12 weeks compared to ~45% with placebo, with symptom severity also significantly reduced.
It’s a meaningful option for women who can’t take hormone therapy (including many breast cancer survivors), or who choose not to.
Liver enzyme monitoring is required at baseline, 1, 2, 3, 6, and 9 months because of a small risk of hepatotoxicity flagged by the FDA in 2024.
It’s not first-line for everyone — hormone therapy remains the most effective treatment for VMS in women without contraindications.
What Veozah actually is
Veozah is the brand name for fezolinetant, an oral medication developed by Astellas Pharma. It’s the first member of a new drug class — neurokinin 3 (NK3) receptor antagonists — approved for menopausal vasomotor symptoms. The dose approved by the FDA is 45 mg once daily.
What makes Veozah different from previous non-hormonal options for hot flushes is the mechanism. SSRIs, SNRIs, gabapentin, and clonidine all work indirectly on hot flushes — they were developed for other conditions and discovered to help vasomotor symptoms as a secondary effect. Fezolinetant was designed specifically to interrupt the brain pathway that generates hot flushes in the first place.
The drug is not a hormone. It contains no estrogen, no progestogen, no testosterone, and has none of the systemic hormonal effects of hormone therapy. That distinction matters clinically: it changes who can use it.
How Veozah works
To understand how Veozah works, it helps to understand what causes a hot flush in the first place. Hot flushes originate in the hypothalamus, the brain’s thermoregulation center. A specific population of neurons there — known as KNDy neurons (named for the three neurotransmitters they produce: kisspeptin, neurokinin B, and dynorphin) — appears to be the central trigger.
In premenopausal women, estrogen suppresses KNDy neuron activity. When estrogen levels drop during the menopause transition, KNDy neurons become hyperactive, enlarge, and start producing excess neurokinin B. The neurokinin B binds to NK3 receptors on temperature-sensing neurons, and the resulting signal drops the brain’s perceived “set point” for body temperature. The body interprets normal core temperature as too hot, triggers a heat-dissipation response — vasodilation, sweating, flushing — and you experience a hot flush.
Fezolinetant blocks the NK3 receptor. Neurokinin B can still be produced, but it can’t bind to the receptor, the misfiring temperature signal doesn’t get sent, and the hot flush is reduced. The mechanism is targeted in a way no prior treatment for hot flushes has been.
For a deeper walk-through of the underlying neuroscience and where it sits in the broader treatment landscape, our pillars on how to stop hot flushes and what causes hot flushes cover the science in more detail.
What the clinical trial data shows
HRT is a treatment that is safe, very similar to your body's hormones, and doctor-recommended. There shouldn't be so much stigma around hormone therapy because the benefits outweigh the risks.
Fezolinetant was studied in three phase 3 clinical trials known as SKYLIGHT 1, 2, and 4. The two efficacy trials (SKYLIGHT 1 and 2) enrolled approximately 500 women each with moderate-to-severe vasomotor symptoms, randomized them to fezolinetant 30 mg, fezolinetant 45 mg, or placebo, and measured changes in VMS frequency and severity over 12 weeks. SKYLIGHT 4 was a 52-week safety study.
The headline results from SKYLIGHT 1 (Lederman 2023, Lancet) and SKYLIGHT 2 (Johnson 2023, Journal of Clinical Endocrinology & Metabolism):
At week 12, women on fezolinetant 45 mg experienced approximately 60% reduction in moderate-to-severe VMS frequency from baseline, compared to roughly 45% reduction with placebo.
The drug reduced VMS severity, not just frequency.
Improvements began within the first one to two weeks of treatment, and continued through the 12-week endpoint.
Effects were sustained through the 52-week safety extension reported in Neal-Perry 2023, Obstetrics & Gynecology.
A few important caveats. The placebo response was large — typical for vasomotor symptom trials — so the drug-placebo difference, while real and statistically significant, is smaller than the raw “60%” reduction suggests in isolation. The trials were 12 weeks for primary efficacy with 52-week safety follow-up, so very long-term data are still accumulating. And as with all clinical trial populations, the women enrolled were selected for moderate-to-severe symptoms and may not represent women with milder VMS.
That said, the SKYLIGHT data are the strongest evidence we have for any non-hormonal prescription option for hot flushes, and the magnitude of effect compares favorably to other non-hormonal options in head-to-head context.
Who Veozah is for
Veozah is FDA-approved for moderate-to-severe vasomotor symptoms associated with menopause. In practice, it’s most often considered for women who:
Have moderate-to-severe hot flushes and night sweats interfering with daily life or sleep
Cannot use hormone therapy because of contraindications such as a history of estrogen-sensitive cancer (including many breast cancer survivors), prior thromboembolic disease, or active liver disease (though Veozah itself requires liver monitoring — see below)
Choose not to use hormone therapy for personal reasons, even when not contraindicated
Have tried other non-hormonal options (SSRIs, SNRIs, gabapentin) and found them ineffective or intolerable
Per the Menopause Society’s 2023 Nonhormone Therapy Position Statement, fezolinetant is now recommended as a non-hormonal option for VMS, alongside established alternatives like certain SSRIs and SNRIs, gabapentin, and oxybutynin. For women with breast cancer who are on tamoxifen or aromatase inhibitors and experiencing severe vasomotor symptoms, Veozah is one of the most clinically significant options to emerge — our guide on tamoxifen side effects covers the broader picture.
Who Veozah is not for
Several groups should not take Veozah, or should think carefully before doing so:
Women with known cirrhosis or severe liver impairment — Veozah is contraindicated.
Women with end-stage renal disease or severe renal impairment — not recommended.
Women taking moderate or strong CYP1A2 inhibitors (cimetidine, fluvoxamine, mexiletine, ciprofloxacin, and others) — co-administration is contraindicated or not recommended because these medications can raise fezolinetant blood levels substantially.
Women already managing well on hormone therapy with no contraindications — switching to a less-effective option without a clinical reason doesn’t make sense.
Women whose primary symptoms are not vasomotor — Veozah does not treat mood, vaginal symptoms, or other menopausal complaints. It’s specifically a VMS treatment.
This isn’t an exhaustive list, and any decision to start should involve a clinician review of your full medical history and current medications.
The liver enzyme issue
In September 2024, the FDA added a boxed warning to Veozah for the risk of rare but serious liver injury, following postmarketing reports of hepatotoxicity. The boxed warning is the FDA’s strongest safety designation.
The label now requires liver enzyme (ALT, AST, alkaline phosphatase, and bilirubin) monitoring at baseline, then at months 1, 2, 3, 6, and 9 of treatment. Women with baseline ALT or AST elevations or other signs of liver disease should not start the drug, and women on the drug should stop if certain liver enzyme thresholds are crossed.
What this means practically: Veozah is not a “fill the script and check back in a year” medication. It requires sustained engagement with a clinician for monitoring, particularly in the first nine months. That’s not a reason to avoid it, but it is a reason to make sure your prescribing clinician has a clear plan for follow-up. The drug is still considered a useful option for the right candidates; it’s just not a hands-off one.
Cases of liver injury reported so far have generally resolved after stopping the drug, but the risk is real and the monitoring requirement is non-negotiable.
What to expect from Veozah
If you start Veozah, the typical experience based on the SKYLIGHT trial data and clinical practice:
Onset of effect. Most women experience noticeable reduction in hot flush frequency and severity within the first one to two weeks. The full effect builds over the first 12 weeks.
Magnitude of effect. Most women will not experience complete elimination of hot flushes. The expected benefit is meaningful reduction — fewer, less severe, less disruptive — not zero symptoms.
Side effects. The most common adverse events in trials were headache, abdominal pain, diarrhea, insomnia, back pain, and hot flushes themselves (an interesting wrinkle — placebo responses in VMS trials run high). Most side effects were mild to moderate. The serious safety concern is liver enzyme elevation, which is why monitoring is required.
Duration. There’s no fixed duration of treatment. Some women take it for the duration of their bothersome vasomotor symptoms and stop when symptoms resolve naturally. Long-term safety data are still accumulating.
Cost and insurance. Veozah is a branded medication with no generic alternative. Cost varies by insurance, plan, and any manufacturer copay assistance programs. This is worth discussing with your prescriber and pharmacist before starting.
Veozah vs. hormone therapy
There's a lot of chatter around hormone replacement therapy. A lot of fear mongering, a lot of 'only I can do this for you the right way.' What I tell all my patients is that HRT is the replacing of the endocrine factors — the estrogen and progesterone — that have gone missing from a woman's body.
For most women without contraindications, hormone therapy remains the most effective treatment for vasomotor symptoms — typically reducing VMS frequency by 75-90% in clinical trials, compared to fezolinetant’s ~60% (with a substantial placebo response factored in). The Menopause Society’s 2022 Hormone Therapy Position Statement and NICE Guideline NG23 both endorse hormone therapy as first-line for moderate-to-severe VMS in appropriately selected women.
Veozah’s role is not to replace hormone therapy for women who can use it, but to provide an effective non-hormonal option for women who can’t or won’t. That’s a meaningful expansion of the available options — for breast cancer survivors, for women with prior thromboembolic disease, and for women who prefer non-hormonal management — but it’s not a wholesale shift in how vasomotor symptoms are treated.
For a broader comparison of non-hormonal options, including SSRIs, SNRIs, gabapentin, and behavioral approaches, our guides on medication for hot flushes and natural remedies for menopause cover the landscape.
What this means for you
If hot flushes and night sweats are interfering with your sleep, work, or quality of life, and either you can’t take hormone therapy or you’ve decided you’d rather not, Veozah is one of the most evidence-supported options now available. The data behind it is solid, the mechanism is well-defined, and the magnitude of benefit is clinically meaningful for many women.
It’s not a casual decision. The boxed warning for liver toxicity, the required monitoring schedule, and the cost mean that starting Veozah is a serious clinical conversation, not a quick prescription. But for the right candidate — someone with moderate-to-severe vasomotor symptoms who can’t or doesn’t want to use hormones — it’s worth knowing this option exists and what the evaluation looks like.
The conversation with a clinician should cover your full medical history, your current medications (to screen for CYP1A2 interactions), baseline liver function, your symptom profile, what you’ve already tried, and whether the monitoring schedule fits your life. A clinician who knows menopause and is familiar with fezolinetant specifically is the right person to have that conversation with.
When to talk to your doctor
Reasonable triggers for asking about Veozah include:
Moderate-to-severe hot flushes or night sweats that interfere with sleep or function
A medical history that makes hormone therapy inappropriate (estrogen-sensitive cancer history, prior thromboembolic disease, certain other conditions)
A personal preference to avoid hormonal treatment
Inadequate response to or intolerance of previous non-hormonal options (SSRIs, SNRIs, gabapentin)
A breast cancer history with bothersome vasomotor symptoms during tamoxifen or aromatase inhibitor treatment
If you’d like a structured way to prepare for that conversation, our guide on talking to your doctor about menopause covers what to bring and how to ask for what you need.
Frequently asked questions
What is Veozah used for?
Veozah (fezolinetant) is FDA-approved for the treatment of moderate-to-severe vasomotor symptoms — hot flushes and night sweats — associated with menopause. It’s a non-hormonal alternative to hormone therapy.
How does Veozah work?
Veozah is a neurokinin 3 (NK3) receptor antagonist. It blocks the NK3 receptors on temperature-sensing neurons in the hypothalamus, interrupting the brain pathway that generates hot flushes. The mechanism is targeted at the actual cause of hot flushes, unlike other non-hormonal options that work indirectly.
How effective is Veozah?
In the SKYLIGHT phase 3 trials, Veozah reduced moderate-to-severe vasomotor symptom frequency by approximately 60% at 12 weeks, compared to about 45% with placebo. Symptom severity also improved significantly. Effects began within the first 1-2 weeks of treatment.
Is Veozah safe?
The FDA added a boxed warning for risk of rare but serious liver injury in September 2024. Liver enzyme monitoring is required at baseline, 1, 2, 3, 6, and 9 months. Common side effects are mostly mild — headache, abdominal pain, insomnia. The drug should not be used in women with cirrhosis, severe renal impairment, or those taking moderate-to-strong CYP1A2 inhibitors.
Can breast cancer survivors take Veozah?
Yes. Because Veozah is non-hormonal, it does not have the contraindications that hormone therapy carries for women with a history of estrogen-sensitive cancer. It’s one of the most clinically relevant non-hormonal options for breast cancer survivors with bothersome vasomotor symptoms, including those on tamoxifen or aromatase inhibitors. Coordination with your oncology team is appropriate.
How long can you take Veozah?
There’s no fixed maximum duration. Long-term safety data continue to accumulate. Some women take it for the duration of their bothersome vasomotor symptoms; others stop when symptoms resolve naturally. The decision should be made with a clinician.
How does Veozah compare to HRT?
Hormone therapy remains the most effective treatment for vasomotor symptoms in women without contraindications, with typical reductions of 75-90% in trials. Veozah’s effect (~60% reduction at 12 weeks) is smaller than HRT but substantially larger than other non-hormonal options. Its role is providing an effective alternative for women who can’t or won’t take hormones.
Sources
Lederman S, Ottery FD, Cano A, et al. Fezolinetant for treatment of moderate-to-severe vasomotor symptoms associated with menopause (SKYLIGHT 1): a phase 3 randomised controlled study. The Lancet. 2023;401(10382):1091-1102.
Johnson KA, Martin N, Nappi RE, et al. Efficacy and safety of fezolinetant in moderate to severe vasomotor symptoms associated with menopause: a phase 3 RCT (SKYLIGHT 2). Journal of Clinical Endocrinology & Metabolism. 2023;108(8):1981-1997.
Neal-Perry G, Cano A, Lederman S, et al. Safety of fezolinetant for vasomotor symptoms associated with menopause: a randomized controlled trial (SKYLIGHT 4). Obstetrics & Gynecology. 2023;141(4):737-747.
The Menopause Society. The 2023 Nonhormone Therapy Position Statement of The North American Menopause Society. Menopause. 2023;30(6):573-590.
The Menopause Society. The 2022 Hormone Therapy Position Statement of The North American Menopause Society. Menopause. 2022;29(7):767-794.
National Institute for Health and Care Excellence. Menopause: identification and management (NG23). Updated November 2024.
Disclaimer
This article is for educational purposes and does not constitute medical advice. Always consult a qualified healthcare provider for guidance on your specific situation. Veozah (fezolinetant) is a prescription medication that requires evaluation by a clinician, baseline liver function testing, and an ongoing monitoring schedule per the FDA-required boxed warning. Specific dosing and decisions about starting, continuing, or stopping the medication should be made with your prescribing clinician based on your individual medical history, current medications, and lab results.
