Elinzanetant: The Second Nonhormonal Pill for Hot Flashes

Table of Contents

1. What Elinzanetant Is
2. The Brain Thermostat Behind a Hot Flash
3. Two Receptors Instead of One
4. From Dose-Finding Trial to Approval
5. OASIS 1 and 2: The 26-Week Trials
6. OASIS 3: A Full Year of Treatment
7. OASIS 4: Hot Flashes From Breast Cancer Treatment
8. Sleep Results
9. Side Effects Reported in the Trials
10. Liver Tests: What the Label and the Trial Data Say
11. Other Warnings and Who the Label Raises Concerns For
12. Drug Interactions on the Label
13. How It Compares With Fezolinetant and Hormone Therapy
14. What Is Not Known
15. Key Research Papers
16. Connections
17. Featured Videos

What Elinzanetant Is

The United States label describes elinzanetant as a neurokinin-1 (NK1) and neurokinin-3 (NK3) receptor antagonist. An antagonist is a molecule that sits on a receptor and stops the body's own signal from switching it on. The label's only approved use is "the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause". Vasomotor symptoms is the medical term for hot flashes and night sweats.

The drug comes as a 60 mg soft capsule. The label states a dose of 120 mg (two capsules) once a day at bedtime, with or without food, swallowed whole. The bedtime timing matters because sleepiness is one of its common side effects.

Some basic facts from the label's pharmacology section, in plain terms:

• The blood level peaks about one hour after a dose.
• About 52% of a swallowed dose reaches the bloodstream.
• The half-life (the time for the blood level to fall by half) is about 45 hours in women with hot flashes, so a steady level builds up over 5 to 14 days of daily use.
• The liver breaks the drug down, mainly through an enzyme called cytochrome P450 3A4. The breakdown products also block the two receptors. A 2025 study in six healthy volunteers found that about 90% of a radioactively labelled dose left the body in the stool and less than 1% in the urine.

The Brain Thermostat Behind a Hot Flash

A hot flash is a sudden wave of heat, flushing and sweating, sometimes followed by chills. The body is behaving as if it has overheated even though it has not. The Menopause page explains how falling estrogen narrows the range of body temperatures the brain will accept.

The cells at the centre of this story sit in a small area at the base of the brain called the hypothalamus. Researchers named them KNDy neurons, after the three messengers they make: kisspeptin, neurokinin B and dynorphin. A 2013 review by Rance and colleagues put forward the idea that these neurons help cause hot flashes. The review noted marked changes in these neurons in postmenopausal women. In rats, the same neurons send fibres to the brain's temperature-control area, which carries neurokinin-3 receptors, the main receptor for neurokinin B. Destroying the KNDy neurons in rats reduced widening of the skin's blood vessels, which is the flushing part of a hot flash. The authors presented this as a hypothesis built largely on animal work.

Human evidence followed. In a 2017 crossover trial in 37 postmenopausal women, an experimental neurokinin-3 blocker (coded MLE4901) given for four weeks cut the weekly number of hot flashes by 45 percentage points compared with placebo. Three women in that small trial had a rise in the liver enzyme alanine aminotransferase to 4.5 to 5.9 times the upper limit of normal, which returned to normal within 90 days. Both findings, a strong effect on hot flashes and a possible liver signal, carried over into later questions about this whole drug family.

Two Receptors Instead of One

Fezolinetant, approved in the United States in May 2023, is labelled as a neurokinin-3 receptor antagonist. It blocks only the receptor for neurokinin B. Elinzanetant blocks that receptor and also the neurokinin-1 receptor, whose natural messenger is a molecule called substance P. The elinzanetant label states that blocking substance P and neurokinin B signalling "on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in thermoregulation associated with hot flashes". Laboratory tests in the label show the drug binds the neurokinin-1 and neurokinin-3 receptors far more strongly than the related neurokinin-2 receptor.

Why add the second receptor? The 2023 dose-finding trial report states that both neurokinin-1 and neurokinin-3 receptors "have been implicated" in hot flashes and in the sleep problems that come with menopause. Whether the neurokinin-1 action adds a real benefit for patients has not been tested directly. No trial has compared elinzanetant with a drug that blocks neurokinin-3 alone in the same women. The comparisons that exist are indirect, and they are described further down this page.

The same pathway also controls reproductive hormones. In a 2021 study of 33 healthy women who still had menstrual cycles, elinzanetant lowered luteinizing hormone, estradiol and progesterone in a dose-related way. The 120 mg dose made the menstrual cycle about seven days longer, and fewer women had progesterone levels consistent with ovulation. The authors raised the drug as a possible future treatment for hormone-driven conditions such as endometriosis and uterine fibroids. That use is not approved.

From Dose-Finding Trial to Approval

Elinzanetant was first developed under the code name NT-814. The phase 2b SWITCH-1 trial, published in 2023, tested daily doses of 40, 80, 120 and 160 mg against placebo in postmenopausal women aged 40 to 65 who had seven or more moderate to severe hot flashes a day. The 120 mg dose reduced hot flash frequency more than placebo at both main time points: by 3.93 more per day at week 4 and by 2.95 more per day at week 12. The 160 mg dose reached a clear difference only at week 4. The 120 mg dose was then carried into the phase 3 program, called OASIS.

The key dates, as the sources report them:

• July 2025: first approval anywhere, in the United Kingdom, according to the journal Drugs' "First Approval" profile.
• 24 October 2025: United States approval, recorded on Drugs@FDA as application NDA 219469, a new molecular entity on standard review. The approval letter covers "moderate to severe vasomotor symptoms due to menopause".
• August 2026: the current United States label lists a new warning section on the risk of seizure, dated 08/2026.

The approval letter also asked the manufacturer for "enhanced pharmacovigilance": every serious and non-serious report of a liver adverse event, from anywhere in the world, is to be sent to the agency within 15 days, through the third year after approval.

All four OASIS trials, the dose-finding trial and the pooled safety analyses on this page were funded by the manufacturer, and several authors are its employees, as the papers disclose.

OASIS 1 and 2: The 26-Week Trials

OASIS 1 and OASIS 2 were twin trials published together in JAMA in 2024. They enrolled postmenopausal women aged 40 to 65 at sites in the United States, Canada, Europe and Israel. The label states that women needed at least 50 moderate to severe hot flashes a week, including night-time ones, to take part. The average age was 54.6 years.

• 396 women in OASIS 1 and 400 in OASIS 2 were randomly assigned to 120 mg of elinzanetant or placebo for 12 weeks.
• After 12 weeks, the placebo group switched to elinzanetant, and everyone took it for another 14 weeks, 26 weeks in all.
• At the start, women had about 13 to 16 moderate to severe hot flashes per 24 hours.

The results, as the trial reports them, compared with placebo:

• At week 4: 3.3 fewer hot flashes a day in OASIS 1 and 3.0 fewer in OASIS 2.
• At week 12: 3.2 fewer a day in both trials.
• Hot flash severity also fell more than with placebo at both time points.
• Sleep disturbance and menopause-related quality of life improved by week 12.

The label's tables show something the headline figures hide: placebo worked well too. In OASIS 1, women on elinzanetant had 7.60 fewer hot flashes a day by week 4, but women on placebo also had 4.31 fewer. By week 12 the figures were 8.66 and 5.44. The "3 fewer per day" result is the gap between the two groups. A 2026 modelling study found that the placebo responses in neurokinin-blocker trials were higher than in trials of other nonhormonal treatments, about as high as in hormone therapy trials. The authors said this may partly explain the size of the effects seen.

About 78% of women completed OASIS 1 and 81% completed OASIS 2.

OASIS 3: A Full Year of Treatment

OASIS 3, published in JAMA Internal Medicine in 2025, was designed mainly to look at safety over 52 weeks. It enrolled 628 postmenopausal women aged 40 to 65 at 83 sites in North America and Europe. Unlike OASIS 1 and 2, it set no minimum number of hot flashes a week. Women only had to be seeking treatment for moderate to severe symptoms. That makes it closer to the mix of women seen in ordinary clinics.

• At week 12, hot flashes fell by 5.4 a day on elinzanetant and 3.5 a day on placebo, a difference of 1.6 a day. This smaller gap partly reflects the milder starting symptoms.
• Over 50 to 52 weeks, the trial found numerical advantages for elinzanetant on hot flash frequency and severity, sleep and quality of life. These later results were not formally tested for statistical significance, and the trial was not designed to test them.
• The trial reports that elinzanetant "was not associated with" liver toxicity, overgrowth of the womb lining (endometrial hyperplasia) or meaningful changes in bone density.
• Side effects judged to be related to treatment occurred in 30.4% of women on elinzanetant and 14.6% on placebo. The most frequent were sleepiness, fatigue and headache.

OASIS 4: Hot Flashes From Breast Cancer Treatment

Many women with hormone receptor-positive breast cancer take endocrine therapy for years. This includes drugs such as tamoxifen and the aromatase inhibitors. Hot flashes are a common side effect, and hormone therapy is not used for them in this group. A 2026 review in the journal Breast describes menopause hormone therapy as "contraindicated in this setting". This is one of the groups where a nonhormonal option matters most.

OASIS 4, published in the New England Journal of Medicine in 2025, enrolled women aged 18 to 70 with moderate to severe hot flashes linked to endocrine therapy for hormone receptor-positive breast cancer, or for its prevention in women at high risk.

• 316 women were assigned to 120 mg of elinzanetant for 52 weeks, and 158 to placebo for 12 weeks followed by elinzanetant for 40 weeks.
• At the start, women had about 11.4 moderate to severe hot flashes a day.
• At week 4, hot flashes fell by 6.5 a day on elinzanetant and 3.0 a day on placebo, a difference of 3.5.
• At week 12, they fell by 7.8 and 4.2 a day, a difference of 3.4.
• In the first 12 weeks, 69.8% of women on elinzanetant and 62.0% on placebo reported at least one adverse event. The most common were headache, fatigue and sleepiness.
• Serious adverse events in those 12 weeks occurred in 8 women (2.5%) on elinzanetant and 1 woman (0.6%) on placebo.

The United States label, as of its August 2026 version, lists menopause as the only approved use and does not include hot flashes caused by endocrine therapy. A 2026 pooled safety analysis describes the drug as approved for hot flashes "associated with menopause, or those caused by adjuvant endocrine therapy for breast cancer treatment". That wording reflects approvals outside the United States. The label does report one breast cancer drug check: taking elinzanetant with tamoxifen caused no clinically significant change in tamoxifen levels. The 2026 Breast review lists use alongside a class of breast cancer drugs called CDK4/6 inhibitors as a safety issue still being worked through.

Sleep Results

A 2025 review notes that severe hot flashes after menopause go along with sleep disorders and low mood. The elinzanetant dose-finding report links the neurokinin-1 receptor to menopausal sleep problems, and the drug has had its own sleep-laboratory trial. The Insomnia page covers sleep problems more widely.

• OASIS 1 and 2: sleep disturbance, measured with a standard questionnaire, improved more than with placebo by week 12.
• NIRVANA (phase 2, 2026): 110 postmenopausal women with frequent hot flashes and broken sleep were studied in a sleep laboratory. At week 4, elinzanetant reduced time awake after first falling asleep by about 22.5 minutes more than placebo. At week 12, the difference had shrunk to less than one minute. When the researchers modelled all the laboratory nights together, after the trial had ended, the results favoured elinzanetant for total sleep time, sleep efficiency and number of awakenings. The issue of Sleep that carried the trial ran a commentary titled "Elinzanetant improves sleep in postmenopausal women. So does placebo."
• Meta-analysis (2026): a review of seven randomised trials with 3,184 women found that neurokinin-blocking drugs improved patient-reported sleep disturbance compared with placebo at 4, 12 and 24 weeks. The effect was larger for elinzanetant than for fezolinetant. The authors rated the certainty of the evidence as low because the results varied widely between trials.

Side Effects Reported in the Trials

The label's table for the year-long OASIS 3 trial lists the side effects that occurred in at least 2% of women and more often than with placebo:

• Headache: 9.6% versus 7.0% on placebo
• Fatigue: 7.3% versus 2.9%
• Dizziness: 6.1% versus 1.9%
• Sleepiness: 5.1% versus 1.3%
• Abdominal pain: 4.5% versus 2.5%
• Rash: 4.2% versus 1.6%
• Diarrhea: 3.8% versus 1.0%
• Muscle spasms: 3.2% versus 0.6%

In OASIS 1 and 2, the label also lists reflux and nausea among the common side effects. Sensitivity to sunlight (photosensitivity) occurred in 0.5% of women on elinzanetant and 0.1% on placebo across the OASIS trials.

A pooled analysis of four trials, published in 2026, covered 765 women on elinzanetant and 754 on placebo over 12 weeks. Side effects of any kind occurred in 50.8% and 43.2% respectively. Stopping treatment early was low but higher on elinzanetant (7.8%) than on placebo (3.6%). A 2026 meta-analysis of five trials with 1,699 women found that elinzanetant roughly doubled the risk of headache, nearly tripled the risk of sleepiness and more than tripled the risk of fatigue compared with placebo. It found no significant difference in serious adverse events.

Next-morning driving. Because the drug acts on the brain and is taken at bedtime, a 2025 study tested 64 healthy women aged 40 to 65 in a driving simulator the next morning. Average lane-keeping after 120 mg or 240 mg stayed within the limit set for the study, with small changes on the first day but not after five days. The label adds that "driving ability was impaired in some subjects" after the first dose, and in a smaller share after five days. Across the three OASIS trials, nervous system effects such as sleepiness, fatigue, dizziness and near-fainting occurred in 11.9% of women on elinzanetant and 3.5% on placebo.

Liver Tests: What the Label and the Trial Data Say

Liver injury is the main safety issue for this drug family. The fezolinetant label carries a boxed warning for liver toxicity (see the Menopause page). The elinzanetant label has no boxed warning, but it does set out liver testing rules:

• Liver blood tests (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and total and direct bilirubin) before starting.
• The label states the drug is not started if either transaminase is at or above two times the upper limit of normal, or if total bilirubin is at or above two times the upper limit of normal.
• A follow-up transaminase test three months after starting.
• The label states the drug is stopped if transaminases go above five times the upper limit of normal, or above three times with bilirubin above two times.

The label lists these signs of possible liver injury: new tiredness, poor appetite, nausea, vomiting, itching, yellow skin or eyes (jaundice), pale stools, dark urine or belly pain. It tells patients to stop the drug at once and get liver tests if they appear.

The numbers behind the rules: in the first 12 weeks of the three OASIS trials, transaminase levels at or above three times normal occurred in 0.6% of women on elinzanetant and 0.4% on placebo (label). A 2026 review of liver safety across 24 phase 1, three phase 2 and four phase 3 studies found:

• Over 52 weeks, transaminase levels at or above three times normal in 1.2% of women on 120 mg and 1.0% on placebo.
• No case meeting Hy's law, the pattern doctors use to flag a drug that may cause serious liver injury, and no sign of blocked bile flow.
• An independent liver panel judged two cases on elinzanetant (out of 1,697 women) and one on placebo (out of 1,028) as probably related to the study drug. Both elinzanetant cases were mild and reversed, with peak levels 7.4 and 3.5 times normal.

That panel concluded that liver test monitoring was "unnecessary in clinical practice". The United States label nonetheless requires the tests before starting and at three months, and the approval letter requires fast reporting of liver events for three years. The two positions sit side by side in the record.

Other Warnings and Who the Label Raises Concerns For

• Pregnancy. Pregnancy is the label's one contraindication. In rat studies, the drug caused pregnancy loss and stillbirth at exposures in the range of the human dose, though not birth defects. The label calls for pregnancy to be ruled out before starting, and for effective contraception during treatment and for two weeks after, in women who could become pregnant.
• Sleepiness and daytime impairment. The label tells patients who feel these effects not to drive or do hazardous work until the effects have gone.
• Seizure. Added in August 2026. One woman with a history of seizures had a seizure in the clinical trials, and seizures have since been reported after approval. Rats given the drug had convulsions at exposures four times or more above the human dose. The label calls for caution in people with a history of seizures or conditions that lower the seizure threshold.
• Liver and kidney disease. The label does not recommend the drug for people with moderate or severe liver impairment, because moderate impairment more than doubled blood levels, or for people with end-stage kidney disease, where it has not been studied.
• Breastfeeding. There are no human data. The drug passes into milk in rats.
• Age. Not enough women over 65 were studied to know whether they respond differently.
• Animal tumour findings. In a two-year rat study, doses giving about 29 times the human exposure increased cancers of the womb lining and lymphomas. These effects were not seen at 7 times the human exposure. The label states that "the clinical significance of these findings is unknown". In the trials, end-of-treatment womb-lining biopsies in 477 women on elinzanetant found no cancers and four abnormalities (0.8%), which the label describes as in line with the expected background rate.

Drug Interactions on the Label

Because the liver enzyme cytochrome P450 3A4 clears most of the drug, medicines that slow or speed up that enzyme change elinzanetant levels a great deal. The label states:

• Strong blockers of the enzyme, and grapefruit juice: the label advises against using them together with elinzanetant. The antifungal itraconazole raised total elinzanetant exposure 6.3-fold.
• Moderate blockers (the label's example is the antibiotic erythromycin, predicted to triple exposure): the label dose drops to one 60 mg capsule a day, then returns to 120 mg once the other drug has cleared.
• Strong and moderate inducers (speeders-up) of the enzyme: the label advises against combining them, because they lower elinzanetant levels and may make it work less well. The seizure medicine carbamazepine cut exposure by 64%.
• Elinzanetant's effect on other drugs: it is itself a weak blocker of the same enzyme. It raised levels of midazolam, a sedative used as a test drug, 1.8-fold. The label advises against combining it with medicines cleared by that enzyme where small changes in level can cause serious harm, unless those medicines' own labels say otherwise.
• No clinically significant change was seen with esomeprazole (an acid blocker), tamoxifen or rosuvastatin (a cholesterol drug).

The label also notes that its effect on the heart's QT interval, when combined with strong enzyme blockers, "has not been sufficiently characterized".

How It Compares With Fezolinetant and Hormone Therapy

No trial has put elinzanetant and fezolinetant, or elinzanetant and hormone therapy, head to head. The comparisons below are indirect. They combine results from separate placebo-controlled trials using statistical methods, which is weaker evidence than a direct trial.

• Matching-adjusted indirect comparison (2026): individual data from the fezolinetant trials were adjusted to resemble the OASIS 1 and 2 populations. The two drugs had "comparable efficacy" on hot flash frequency and severity. Sleep disturbance improved with both, but more with elinzanetant, and this did not lead to a significant difference in overall quality of life. Several authors of this analysis worked for the maker of fezolinetant.
• Network meta-analysis (2026): across 17 trials, elinzanetant reduced daily hot flashes more than low-dose paroxetine, desvenlafaxine and gabapentin, and was comparable to fezolinetant on the share of women whose hot flashes halved. It improved the sleep disturbance score more than fezolinetant. Quality of life scores did not differ. Two authors of this analysis worked for the maker of elinzanetant.
• Model-based meta-analysis (2026): after removing the placebo effect, fezolinetant 45 mg reduced hot flash frequency by 20.6% and elinzanetant 120 mg by 19.6%. Compared with earlier published estimates, these effects were greater than paroxetine's (14.8%) and corresponded to about 52% and 49% of the effect seen with estradiol at 12 weeks.

Where the 2026 American College of Physicians guideline places it. The guideline, published in October 2026, recommends estrogen (with a progestogen for women with a uterus) as first-line treatment for menopausal hot flashes, a strong recommendation on high-certainty evidence. It suggests the antidepressants desvenlafaxine or venlafaxine as second-line options. As third-line options, for women who cannot take or do not tolerate the first two, it lists the antidepressants escitalopram or paroxetine, gabapentin, or "neurokinin receptor antagonists, either elinzanetant or fezolinetant", the last on moderate-certainty evidence. The guideline also calls for informed decision-making that weighs cost and access. The Non-Hormonal Options page covers those other medicines.

What Is Not Known

• Safety beyond one year. The longest placebo-controlled data are 52 weeks (OASIS 3 and OASIS 4). The 2026 pooled safety analysis states that real-world data after approval are needed "to better characterize the long-term safety profile". SWAN, the long-running United States study of midlife women, found that hot flashes last a median of 7.4 years (see the Menopause page), so many women may take the drug for far longer than it has been studied.
• Head-to-head comparisons. There is no direct trial against fezolinetant, hormone therapy or the antidepressants used for hot flashes.
• Whether the neurokinin-1 action adds anything. The sleep advantage over fezolinetant comes only from indirect comparisons, and the laboratory sleep benefit in NIRVANA faded by week 12.
• Liver risk in everyday use. The trial data found few liver problems, but trials of a few thousand women cannot rule out rare liver injury. The three-year fast-reporting requirement in the approval letter is aimed at such cases.
• Seizures. The warning added in August 2026 rests on one trial case and reports after approval. How often seizures occur, and in whom, is not yet known.
• Long-term heart and bone effects. A 2025 review suggested that easing hot flashes and broken sleep might in theory lower heart and bone risks, but stated that dedicated studies are needed to test this. OASIS 3 found no meaningful change in bone density over a year.
• Older women, and women with liver or kidney disease. Few women over 65 were studied, and people with moderate or severe liver impairment or end-stage kidney disease are outside the label.

Decisions about menopause medicines belong with a clinician who knows a woman's full history and other medicines.

Key Research Papers

1. Pinkerton JV, Simon JA, Joffe H, Maki PM, Nappi RE, Panay N, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024;332(16):1343-54. PubMed PMID: 39172446
2. Panay N, Joffe H, Maki PM, Nappi RE, Pinkerton JV, Simon JA, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Internal Medicine. 2025;185(11):1319-1327. PubMed PMID: 40920404
3. Cardoso F, Parke S, Brennan DJ, Briggs P, Donders G, Panay N, et al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. The New England Journal of Medicine. 2025;393(8):753-763. PubMed PMID: 40454634
4. Lewis JH, Andrade RJ, Larrey D, Horsmans Y, Anderson RA, Trajanovic M, et al. Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant. Drug Safety. 2026;49(8):985-1002. PubMed PMID: 41849128
5. Pinkerton JV, Francuski M, Nappi RE, Simon JA, Lu C, Djordjevic S, et al. Safety and tolerability of elinzanetant: a pooled analysis from four randomized clinical trials. EClinicalMedicine. 2026;101:104250. PubMed PMID: 42923369
6. Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, et al. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023;30(3):239-246. PubMed PMID: 36720081
7. Baker FC, Joffe H, Soares CN, Maki PM, Bajbouj M, Nappi RE, et al. Elinzanetant in postmenopausal women with sleep disturbance: results from the randomized, phase II NIRVANA study. Sleep. 2026;49(10):zsag208. PubMed PMID: 42520241
8. Lappin JM, Perrault AA, Gordon CJ. Elinzanetant improves sleep in postmenopausal women. So does placebo. Sleep. 2026;49(10):zsag210. PubMed PMID: 42520219
9. Lemos MJ, Lopes de Mattos IL, Kaunitz AM. Effects of neurokinin receptor antagonists on sleep disturbance in menopausal women: a systematic review and meta-analysis of randomized controlled trials. Menopause. 2026 Oct 6 (online ahead of print). PubMed PMID: 42837121
10. Francke K, Klein S, Burke J, Schultze-Mosgau MH, Kay G. The Effects of Elinzanetant on Simulated Driving Performance in Healthy Women: A Randomized Phase I Study. Clinical and Translational Science. 2025;18(7):e70282. PubMed PMID: 40569207
11. Schulz SI, Schultze-Mosgau MH, Engelen A, Singh N, Pawsey S, Francke K, et al. Mass Balance Recovery, Absorption, Metabolism, and Excretion of Elinzanetant in Healthy Human Volunteers and in vitro Biotransformation. European Journal of Drug Metabolism and Pharmacokinetics. 2025;50(1):91-103. PubMed PMID: 39719488
12. Pawsey S, Mills EG, Ballantyne E, Donaldson K, Kerr M, Trower M, et al. Elinzanetant (NT-814), a Neurokinin 1,3 Receptor Antagonist, Reduces Estradiol and Progesterone in Healthy Women. The Journal of Clinical Endocrinology and Metabolism. 2021;106(8):e3221-e3234. PubMed PMID: 33624806
13. Rance NE, Dacks PA, Mittelman-Smith MA, Romanovsky AA, Krajewski-Hall SJ. Modulation of body temperature and LH secretion by hypothalamic KNDy (kisspeptin, neurokinin B and dynorphin) neurons: a novel hypothesis on the mechanism of hot flushes. Frontiers in Neuroendocrinology. 2013;34(3):211-27. PubMed PMID: 23872331
14. Prague JK, Roberts RE, Comninos AN, Clarke S, Jayasena CN, Nash Z, et al. Neurokinin 3 receptor antagonism as a novel treatment for menopausal hot flushes: a phase 2, randomised, double-blind, placebo-controlled trial. Lancet. 2017;389(10081):1809-1820. PubMed PMID: 28385352
15. Lee A. Elinzanetant: First Approval. Drugs. 2026;86(1):121-125. PubMed PMID: 41222830
16. Stute P, Shapiro C M M, Morga A, Tai TA, Ajmera M, Muresan B, et al. Fezolinetant compared with elinzanetant for the treatment of vasomotor symptoms associated with menopause: A matching-adjusted indirect comparison. Maturitas. 2026;205:108782. PubMed PMID: 41418588
17. Wojciechowski P, Kolonko K, Giannopoulou A, Smela B, Olewinska E, Bolling KR, et al. Comparative Efficacy of Elinzanetant Versus Other Non-Hormonal Pharmaceutical Therapies for the Treatment of Moderate-to-Severe Vasomotor Symptoms Associated With Menopause: A Network Meta-Analysis. BJOG. 2026 Mar 15 (online ahead of print). PubMed PMID: 41834312
18. Wang S, Lv Y, Chen J, Yang J, Xu L, Huang J, et al. Quantitative assessment of neurokinin receptor antagonists in menopausal hot flashes: a model-based meta-analysis. Menopause. 2026 Oct 13 (online ahead of print). PubMed PMID: 42868052
19. Afifi E, Abdelaziz Ismail R, Ashraf Aldbash A, Ibrahim A, Osama A, Azzam R, et al. Elinzanetant: Efficacy and safety in the management of vasomotor symptoms in postmenopausal women, a systematic review and meta-analysis with grading of recommendations assessment, development, and evaluation assessment. International Journal of Gynaecology and Obstetrics. 2026;174(2):579-598. PubMed PMID: 41732998
20. Qaseem A, Mackey K, Yost J, Shekelle PG, Shamliyan TA, Cross JT Jr. Pharmacologic Treatments for Females With Menopausal Vasomotor Symptoms: A Clinical Guideline From the American College of Physicians. Annals of Internal Medicine. 2026 Oct 6 (online ahead of print). PubMed PMID: 42832802
21. Pogoda K, Arecco L, Lambertini M. Neurokinin pathway antagonists for vasomotor symptoms in women with breast cancer: focus on elinzanetant and fezolinetant. Breast. 2026;88:104812. PubMed PMID: 42160911
22. Cagnacci A, Xholli A, Fiamberti M, Londero AP. Neurokinin Antagonists to Treat Vasomotor Symptoms-Possible Implications for Long-Term Health and Disease. Journal of Clinical Medicine. 2025;14(19):6852. PubMed PMID: 41095931
23. Pinkerton JV, Simon JA, Panay N, Nappi RE, Brennan DJ, Donders G, et al. Consistency of efficacy and safety of elinzanetant for vasomotor symptoms and sleep disturbance associated with menopause across different populations: a review of the OASIS clinical trial program. Maturitas. 2026;212:109075. PubMed PMID: 42537360

PubMed Topic Searches

1. PubMed: elinzanetant
2. PubMed: neurokinin receptor antagonists for vasomotor symptoms
3. PubMed: KNDy neurons and hot flushes
4. PubMed: elinzanetant and breast cancer endocrine therapy

Other Sources

1. DailyMed: elinzanetant capsules, prescribing label (United States National Library of Medicine), version of August 2026
2. FDA approval letter, elinzanetant capsules for moderate to severe vasomotor symptoms due to menopause, 24 October 2025 (NDA 219469)
3. DailyMed: fezolinetant tablets, prescribing label with boxed warning for liver toxicity (United States National Library of Medicine)

Connections

• Drugs — every drug page on the site
• Menopause — the condition, hormone therapy and every treatment option
• Hot Flashes and Night Sweats — the vasomotor symptoms of menopause
• Non-Hormonal Options — antidepressants, gabapentin and fezolinetant
• Hormone Replacement Therapy Risks — breast cancer, clots and stroke
• Breast Cancer — where endocrine therapy and its hot flashes come from
• Night Sweats — causes beyond menopause
• Insomnia — sleep problems and their treatments
• Menopause: Why the Hormones Fall and What Changes — interactive animation

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