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Research · Medication

Fezolinetant and elinzanetant

Pooled trials found fezolinetant and elinzanetant cut moderate to severe hot flashes by about 2 to 3 more a day than placebo, while placebo alone cut 3.5 to 6.5. Fezolinetant carries an FDA boxed warning for liver injury. Sleepiness, fatigue or dizziness occurred in 11.9% on elinzanetant against 3.5% on placebo. Neither changed bone density over a year.

Add to Bio HackChecked 2026-11-13
Status
Prescription drugs in the US, both FDA-approved for moderate to severe vasomotor symptoms (hot flashes and night sweats) due to menopause. Fezolinetant (Veozah) was approved in 2023 and has carried a boxed warning for liver injury since December 2024 [1][2]. Elinzanetant (Lynkuet) was approved in 2025 and is contraindicated in pregnancy [3].
Also called
fezolinetant, Veozah, Veoza, elinzanetant, Lynkuet, NT-814, BAY 3427080, neurokinin 3 receptor antagonist, NK3 receptor antagonist, neurokinin 1 and 3 receptor antagonist, NK1/NK3 antagonist, non-hormonal hot flash pill
Taken for
hot flashes, night sweats, menopause symptoms, sleep during menopause, hot flashes when hormone therapy is not an option, hot flashes from breast cancer treatment, menopause quality of life

Strong several reviews agree · Moderate one review or consistent trials · Limited one or a few small studies · Untested no study in people, listed with what it rests on

Shown to help7

Reported risks9

What people take it for, and what was found

Shown to help7

StrongStudied in womenVery common

Hot flashes: fezolinetant compared with placebo

Shown to cut moderate to severe hot flashes by about 2 to 2.6 more a day than placebo in menopausal women, though placebo alone cut 4 to 5 a day.

Compared with placebo [1][4][5][6][7][8]

The numbers and sources
How common
Very common: more than 1 in 10 people.
Effect
In the two pivotal 12-week trials, women started with 10.4 to 11.8 moderate to severe hot flashes a day. At week 12 the 45 mg dose cut them by 6.4 and 7.5 a day, against 3.9 and 5.0 on placebo, differences of 2.6 (95% CI 1.7 to 3.4) and 2.5 (95% CI 1.5 to 3.6). Severity scores fell 0.2 to 0.3 points more than on placebo from a baseline of 2.4 [1]. In one trial, 60.5% on 45 mg and 42.5% on placebo had at least a 50% drop in hot flashes by week 12 [8]. Pooling 5 trials, fezolinetant lowered daily hot flashes by 2.62 more than placebo (95% CI 1.84 to 3.41), a 22.5% greater improvement (95% CI 15.4 to 29.7) [4]. A review of 6 trials found fewer hot flashes than placebo at 4 weeks (Cohen's d -0.56, 95% CI -0.79 to -0.34) and 12 weeks (d -0.34) [6], and a review of 10 trials of both drugs found the same direction [5].
Population
1,022 women aged 40 to 65 with at least 7 moderate to severe hot flashes a day in the two pivotal trials, mean age 54 [1][7][8]. 2,168 women in 5 trials [4]. 3,657 women in 6 trials [6]. 4,663 women in 10 trials of fezolinetant or elinzanetant [5].
Sources
[1], [4], [5], [6], [7], [8]
Caveats
Placebo alone cut hot flashes by 3.9 to 5.0 a day, a third to two fifths of the starting count [1]. Placebo control lasted 12 weeks, and the 40-week extensions had no placebo arm [1]. The pivotal trials were funded by Astellas, the maker [7].
StrongStudied in women

Hot flashes: elinzanetant compared with placebo

Shown to cut moderate to severe hot flashes by 1.6 to 3.2 more a day than placebo in menopausal women, while placebo alone cut 3.5 to 6.5 a day.

Compared with placebo [3][5][9][10][11]

The numbers and sources
Effect
In OASIS 1 and 2, women started with 13.4 to 16.2 moderate to severe hot flashes a day. At week 12, 120 mg at bedtime cut them by 8.7 and 9.7 a day, against 5.4 and 6.5 on placebo, a difference of 3.2 in each trial [3][10]. Severity fell 0.3 to 0.4 points more than on placebo [10]. In OASIS 3, which set no minimum hot flash count, the week 12 drop was 5.4 a day against 3.5 on placebo, a difference of 1.6 (95% CI 1.1 to 2.0) [11]. Pooling 5 trials, elinzanetant lowered daily hot flashes by 2.30 more than placebo at week 12 (95% CI 1.59 to 3.00) and severity by 0.35 points more (95% CI 0.28 to 0.43) [9]. A review of 10 trials of both drugs found the same direction [5].
Population
796 women aged 40 to 65 with at least 50 moderate to severe hot flashes a week in OASIS 1 and 2, mean age 54.6 [3][10]. 628 women aged 40 to 65 in OASIS 3, followed 52 weeks [11]. 1,699 women in 5 trials [9]. 4,663 women in 10 trials [5].
Sources
[3], [5], [9], [10], [11]
Caveats
Placebo alone cut hot flashes by 3.5 to 6.5 a day [3][11]. OASIS 1 and 2 were placebo-controlled for 12 weeks only, then everyone took elinzanetant [10]. OASIS 3 reported its 52-week results descriptively, without statistical tests [11].
LimitedStudied in womenVery common

Hot flashes when hormone therapy is not an option

One trial found fezolinetant cut hot flashes by 1.93 more a day than placebo over 24 weeks in women unsuited to or avoiding hormone therapy.

Compared with placebo [12][13]

The numbers and sources
How common
Very common: more than 1 in 10 people.
Effect
At week 24, fezolinetant 45 mg lowered daily moderate to severe hot flashes by 1.93 more than placebo (95% CI 1.22 to 2.64) and severity by 0.39 points more (95% CI 0.21 to 0.57) [12]. At week 24, 60.6% on fezolinetant and 46.0% on placebo had at least a 50% drop (OR 1.82, 95% CI 1.25 to 2.65). At week 1 the shares were 42.0% and 14.6% [13].
Population
453 women aged 40 to 65 in 16 countries, 96.7% white, judged unsuitable for hormone therapy because it was contraindicated, needed caution, had been stopped before, or was declined by choice [12][13].
Sources
[12], [13]
Caveats
46.0% on placebo also had at least a 50% drop [13]. Most women were in the "averse" (37.2%) or "caution" (36.5%) groups, not the contraindicated group [12]. One trial.
LimitedStudied in women

Hot flashes from breast cancer endocrine therapy

One trial found elinzanetant cut hot flashes by 3.4 more a day than placebo over 12 weeks in women on endocrine therapy for breast cancer or its prevention.

Compared with placebo [14]

The numbers and sources
Effect
Women started with 11.4 to 11.5 moderate to severe hot flashes a day. At week 12 they fell by 7.8 a day on elinzanetant 120 mg and 4.2 on placebo, a difference of 3.4 (95% CI 2.5 to 4.2). At week 4 the drops were 6.5 and 3.0 [14].
Population
474 women aged 18 to 70 taking endocrine therapy for hormone receptor-positive breast cancer or to prevent it, randomized 2:1 [14].
Sources
[14]
Caveats
Funded by Bayer, the maker [14]. Placebo alone cut 4.2 a day [14]. The US label covers hot flashes due to menopause, not those caused by endocrine therapy [3]. Fezolinetant had no published trial in this group.
ModerateStudied in women

Sleep disturbance

Shown to ease self-reported sleep disturbance slightly against placebo in women with hot flashes. In a sleep-lab trial, elinzanetant's effect on night waking had faded by week 12.

Compared with placebo [4][8][10][12][15]; fezolinetant compared with elinzanetant, indirectly across trials [16]

The numbers and sources
Effect
On the PROMIS sleep disturbance scale, fezolinetant 45 mg lowered scores 2.0 points more than placebo at week 12 (95% CI 0.6 to 3.5), while the 30 mg dose did not differ (0.7 points, 95% CI -0.8 to 2.1) [8]. In women unsuited to hormone therapy the difference was 2.5 points at week 24 (95% CI 1.1 to 3.9) [12]. A meta-analysis found better sleep quality than placebo [4]. Elinzanetant improved sleep disturbance against placebo at week 12 in OASIS 1 and 2 [10]. In a 12-week sleep laboratory trial, elinzanetant lowered wake time after sleep onset by 22.5 minutes more than placebo at week 4 (90% CI 9.5 to 35.5) and by 0.9 minutes at week 12 (90% CI -12.1 to 14.0) [15]. An indirect comparison found sleep disturbance improved more with elinzanetant than fezolinetant [16].
Population
500 women in a fezolinetant trial [8]. 453 women unsuited to hormone therapy [12]. 5 trials [4]. 796 women in OASIS 1 and 2 [10]. 110 postmenopausal women with hot flashes and at least 30 minutes awake after sleep onset [15].
Sources
[4], [8], [10], [12], [15], [16]
Caveats
The OASIS 1 and 2 abstract gives no effect size for sleep [10]. The sleep laboratory trial was a phase 2 study reporting 90% intervals [15]. The indirect comparison shares authors with an Astellas-sponsored analysis [17][16].
ModerateStudied in women

Menopause quality of life

Shown to improve menopause quality of life scores by about 0.6 points more than placebo in pooled fezolinetant trials. Elinzanetant also improved them in trials.

Compared with placebo [4][8][10]

The numbers and sources
Effect
Pooling 5 trials, fezolinetant improved the Menopause-Specific Quality of Life (MENQOL) total score by 0.60 points more than placebo (95% CI 0.28 to 0.92) [4]. In one trial, from a baseline of about 4.4, the score fell 0.59 points more than placebo on 45 mg and 0.42 more on 30 mg at week 4 [8]. Elinzanetant improved menopause-related quality of life against placebo at week 12 [10]. An indirect comparison found no difference in MENQOL between the two drugs [16].
Population
2,168 women in 5 trials [4]. 500 women [8]. 796 women [10].
Sources
[4], [8], [10], [16]
Caveats
The elinzanetant abstract gives no effect size [10]. Quality of life was a secondary outcome in each trial.
LimitedStudied in women

Compared with hormone therapy and other non-hormonal drugs

Limited evidence: an indirect comparison funded by the maker found fezolinetant cut hot flashes about as much as hormone therapy and more than paroxetine, desvenlafaxine or gabapentin.

Compared with 27 hormone therapy regimens, low-dose paroxetine, desvenlafaxine, extended-release gabapentin and placebo, compared indirectly across trials [17]

The numbers and sources
Effect
In a Bayesian network meta-analysis, the change in hot flash frequency did not differ between fezolinetant 45 mg and any of 27 hormone therapy regimens. Fezolinetant lowered daily moderate to severe hot flashes more than paroxetine 7.5 mg (by 1.66, 95% credible interval 0.63 to 2.71), desvenlafaxine 50 to 200 mg (by 1.12 to 2.16) and extended-release gabapentin 1,800 mg (by 1.63, 0.48 to 2.81). Tibolone 2.5 mg lowered severity more than fezolinetant, and tibolone and conjugated estrogens with bazedoxifene had more women with a 75% drop [17].
Population
The pooled fezolinetant pivotal trials and 23 comparator publications of phase 3 or 4 randomized trials in postmenopausal women with at least 7 moderate to severe hot flashes a day or 50 a week, published through June 2021 [17].
Sources
[17]
Caveats
No trial compared fezolinetant with hormone therapy directly. Sponsored by Astellas, with Astellas employees among the authors, and the protocol was not registered [17]. Tibolone is not sold in the US [17].

Doses studied

The fezolinetant pivotal and safety trials used 30 mg or 45 mg once daily for 12 to 52 weeks, and the label dose is 45 mg once daily [1][7][8][18]. The elinzanetant trials used 120 mg once daily at bedtime for 12 to 52 weeks [10][11][14]. The elinzanetant label gives 120 mg at bedtime, and 60 mg when a moderate CYP3A4 inhibitor is taken [3].

Risks

Reported risks8

ModerateStudied in womenVery common

Sleepiness, fatigue and dizziness on elinzanetant

The label warns of sleepiness and daytime impairment. Nervous system effects such as sleepiness, fatigue and dizziness occurred in 11.9% on elinzanetant against 3.5% on placebo.

The numbers and sources
How common
Very common: more than 1 in 10 people.
Effect
Across the three OASIS trials, sleepiness, fatigue, vertigo, dizziness or near-fainting occurred in 11.9% on elinzanetant and 3.5% on placebo. Over 52 weeks in OASIS 3, fatigue occurred in 7.3% against 2.9%, dizziness 6.1% against 1.9%, and sleepiness 5.1% against 1.3% [3]. Pooled trials found sleepiness (RR 2.96, 95% CI 1.42 to 6.17) and fatigue (RR 3.39, 95% CI 1.77 to 6.49) raised against placebo [9]. In a driving simulator study of 64 healthy women 9 hours after a bedtime dose, mean lane weaving did not reach the impairment threshold, but some women were impaired after the first dose [3].
Population
1,420 women in OASIS 1 to 3 [3]. 5 trials with 1,699 women [9]. 64 healthy women, mean age 52.1 [3].
Sources
[3], [9]
Caveats
The label advises against driving or hazardous work while these effects last [3].
ModerateStudied in womenCommon

FDA boxed warning: liver injury with fezolinetant

FDA added a boxed warning for liver injury in 2024. In trials, liver enzymes rose above 3 times normal in 2.3% on fezolinetant against 0.9% on placebo.

The numbers and sources
How common
Common: between 1 in 100 and 1 in 10 people.
Effect
Across three 52-week trials, ALT or AST above 3 times the upper limit of normal occurred in 2.3% of 1,100 women on 45 mg (2.7 per 100 person-years) and 0.9% of 952 on placebo (1.5 per 100 person-years), with no bilirubin rise above 2 times normal [1]. In the 52-week safety trial, rises above 3 times normal occurred in 12 of 589 women on 45 mg, 8 of 590 on 30 mg and 6 of 583 on placebo, with no Hy's law cases [18]. After approval, FDA reviewed a case of liver injury with jaundice, itching, pale stools and dark urine within about 40 days of starting [2]. The label reports postmarketing cases with transaminases up to 50 times normal and bilirubin up to 5 times normal, which resolved after stopping [1]. The label calls for liver blood tests before starting, monthly for 3 months, and at 6 and 9 months [1].
Population
1,100 women on fezolinetant 45 mg and 952 on placebo in three trials [1]. 1,830 women in the 52-week safety trial [18]. Postmarketing reports [1][2].
Sources
[1], [2], [18]
Caveats
Postmarketing reports have no denominator, so how often serious injury occurs is not known [1][2]. The label contraindicates fezolinetant in cirrhosis and severe kidney impairment [1].
ModerateStudied in womenCommon

Liver enzymes on elinzanetant

The label warns of liver enzyme rises and calls for liver tests. In trials, rises above 3 times normal occurred in 1.2% on elinzanetant against 1.0% on placebo.

The numbers and sources
How common
Common: between 1 in 100 and 1 in 10 people.
Effect
Up to 12 weeks, ALT or AST at or above 3 times normal occurred in 0.6% on elinzanetant and 0.4% on placebo [3]. Over weeks 1 to 52 in pooled trials, rises above 3 times normal occurred in 1.2% on 120 mg and 1.0% on placebo, with no Hy's law cases. A blinded liver board judged 2 of 1,697 cases on elinzanetant (0.12%) and 1 of 1,028 on placebo (0.10%) probably drug-related, with peak ALT of 7.4 and 3.5 times normal, both mild and reversible [19]. In the 52-week trial, 6 women on elinzanetant and 4 on placebo met close liver observation criteria [11].
Population
Women in OASIS 1 to 3 [3]. Pooled phase 1 to 3 studies, including OASIS 1 to 4 [19]. 628 women [11].
Sources
[3], [19], [11]
Caveats
The pooled analysis covers the maker's own trial program, and its liver board judged routine testing unnecessary, while the US label still calls for liver tests at baseline and 3 months [3][19].
ModerateStudied in womenCommon

Common side effects of fezolinetant

Shown to raise abdominal pain, diarrhea, insomnia, back pain and hot flushes slightly over placebo, each in under 5% of women in a year-long trial.

The numbers and sources
How common
Common: between 1 in 100 and 1 in 10 people.
Effect
In the 52-week placebo-controlled trial, rates on 45 mg against placebo were abdominal pain 4.3% and 2.1%, diarrhea 3.9% and 2.6%, insomnia 3.9% and 1.8%, back pain 3.0% and 2.1%, and hot flush 2.5% and 1.6% [1]. Any side effect occurred in 62.9% on 45 mg and 55.3% on placebo across three trials [20]. Stopping for side effects occurred in 4.6% on 45 mg and 4.3% on placebo [18]. Serious side effects did not differ from placebo in a pooled analysis (OR 1.57) [6].
Population
609 women on 45 mg and 610 on placebo [1][18]. 1,100 on 45 mg and 952 on placebo across three trials [20]. 6 trials [6].
Sources
[1], [20], [18], [6]
Caveats
The pooled safety analysis was written by the maker's investigators [20].
ModerateStudied in womenCommon

Common side effects of elinzanetant

Shown to raise headache, stomach pain, rash, diarrhea and muscle spasms over placebo, and twice as many women stopped for side effects as on placebo.

The numbers and sources
How common
Common: between 1 in 100 and 1 in 10 people.
Effect
Over 52 weeks, rates on elinzanetant against placebo were headache 9.6% and 7.0%, abdominal pain 4.5% and 2.5%, rash 4.2% and 1.6%, diarrhea 3.8% and 1.0%, and muscle spasms 3.2% and 0.6%. Mild to moderate sunlight sensitivity occurred in 0.5% and 0.1% [3]. Treatment-related side effects occurred in 30.4% and 14.6% [11]. In pooled trials, stopping for side effects was more likely (RR 2.18, 95% CI 1.45 to 3.28), and serious side effects did not differ significantly (RR 1.70, 95% CI 0.82 to 3.54) [9]. In the breast cancer trial, serious side effects in weeks 1 to 12 occurred in 2.5% on elinzanetant and 0.6% on placebo [14].
Population
313 women on elinzanetant and 314 on placebo in OASIS 3 [3][11]. 5 trials [9]. 474 women on breast cancer endocrine therapy [14].
Sources
[3], [11], [9], [14]
Caveats
Sunlight sensitivity rests on few events [3].
LimitedStudied in womenRare

Seizures on elinzanetant

Case reports: seizures were reported in trials and after approval, and rats given the drug had convulsions. The label warns of a seizure risk.

The numbers and sources
How common
Rare: fewer than 1 in 1,000 people.
Effect
One woman with a history of seizures (under 0.1%) had a seizure in the trials, and postmarketing cases have been reported. Rats developed convulsions at exposures 4 or more times the human dose [3].
Population
Women in the elinzanetant trials and after approval. Rats [3].
Sources
[3]
Caveats
Postmarketing reports have no denominator [3].
ModerateHow often is not known

Interaction: fezolinetant and CYP1A2 inhibitors

The label contraindicates use with CYP1A2 inhibitors, after fluvoxamine raised fezolinetant exposure by 840%, mexiletine by 360% and cimetidine by 100%.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Fezolinetant is broken down mainly by the liver enzyme CYP1A2. Taken with fluvoxamine, a strong inhibitor, its peak level rose 80% and total exposure (AUC) 840%. With mexiletine, a moderate inhibitor, AUC rose 360%, and with cimetidine, a weak inhibitor, 100%. The label contraindicates use with weak, moderate or strong CYP1A2 inhibitors. Smoking did not change exposure [1].
Population
Drug interaction studies reported in the label [1].
Sources
[1]
Caveats
The label names these three drugs as examples of the class.
ModerateHow often is not known

Interaction: elinzanetant and CYP3A4 drugs

The label says to avoid strong CYP3A4 inhibitors, grapefruit juice and CYP3A4 inducers. Itraconazole raised elinzanetant exposure 6.3-fold, and elinzanetant raised midazolam 1.8-fold.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Elinzanetant is broken down mainly by CYP3A4. Itraconazole raised its peak level 3.3-fold and AUC 6.3-fold, and carbamazepine lowered AUC by 64%. The label says to avoid strong CYP3A4 inhibitors, grapefruit juice and moderate or strong inducers, and gives 60 mg with moderate inhibitors. Elinzanetant itself raised midazolam AUC 1.8-fold, so the label advises against sensitive CYP3A4 drugs where small changes cause serious effects [3].
Population
Drug interaction studies reported in the label [3].
Sources
[3]
Caveats
Some figures for moderate and weak inhibitors were predicted by modeling, not measured [3].

Mixed results1

LimitedStudied in womenHow often is not known

Possible cancer signal with fezolinetant

Mixed results: a pooled safety analysis found no excess of neoplasms, while two 2026 reviews describe a dose-related imbalance in non-benign neoplasms in the trials.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
Controlled for exposure, the pooled analysis of three trials found no increased risk of benign or non-benign neoplasms against placebo [20]. A 2026 review counted non-benign neoplasms at 0.2, 0.7 and 1.2 per 100 subject-years on placebo, 30 mg and 45 mg, a relative risk at 45 mg of 6.6 (95% CI 0.9 to 51.3), not statistically significant. It reports that regulators set the imbalance aside as chance [21]. A second review reports that meta-analyses and pooled analyses showed a significant rise in non-benign neoplasms [22].
Population
3,155 women in three 52-week trials [20]. Reviews of trial and regulatory data [21][22].
Sources
[20], [21], [22]
Caveats
Neoplasm counts were small and follow-up was a year. The two reviews disagree on whether the rise was significant [21][22]. The pooled analysis was written by the maker's investigators [20].

Checked, no increase found2

ModerateStudied in women

Uterine lining

Not shown to raise endometrial hyperplasia or cancer beyond FDA limits in biopsy studies, with 2 cases among 350 women on fezolinetant and no cancers among 477 on elinzanetant.

The numbers and sources
How common
Uncommon: between 1 in 1,000 and 1 in 100 people.
Effect
After 12 months, endometrial biopsies found hyperplasia or cancer in 2 of 350 women on fezolinetant 45 mg (0.6%, one simple hyperplasia and one adenocarcinoma) and 0 of 186 on placebo. The upper confidence limit of 1.8% was inside the FDA limit of 4% [1]. In the 52-week safety trial, 1 of 203 women on 45 mg had hyperplasia and 1 of 210 on 30 mg had cancer [18]. Among 477 women biopsied after elinzanetant, 4 (0.8%) had abnormalities, 3 of them hyperplasia, and none had cancer [3]. The 52-week elinzanetant trial found no endometrial hyperplasia linked to the drug [11].
Population
350 women on fezolinetant and 186 on placebo with biopsies [1]. 599 women with biopsies in the safety trial [18]. 477 women on elinzanetant and 132 on placebo [3]. 628 women [11].
Sources
[1], [18], [3], [11]
Caveats
Biopsy studies lasted up to a year.
ModerateStudied in women

Bone density

Not shown to change bone density against placebo over a year in postmenopausal women, in the long-term safety trials of either drug.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
In the 52-week fezolinetant safety trial, changes in bone mineral density and trabecular bone score were similar across groups [18]. In the 52-week elinzanetant trial there were no meaningful changes in bone density or bone turnover markers [11].
Population
1,830 postmenopausal women [18]. 628 postmenopausal women [11].
Sources
[18], [11]
Caveats
Bone density was a secondary safety measure, and fractures were not studied.

Possible, not studied in people1

UntestedHow often is not known

Pregnancy

Not studied in people. In animal studies elinzanetant caused stillbirths and litter loss, and fezolinetant caused embryo deaths at high doses. Elinzanetant's label contraindicates pregnancy.

No study in people. This rests on animal studies.

The numbers and sources
How common
How often is not known: the sources give no rate.
Effect
In rats, elinzanetant from mid-pregnancy through nursing raised stillbirths and total litter loss at doses giving about the human exposure. Its label contraindicates use in pregnancy and calls for contraception during use and for 2 weeks after [3]. Fezolinetant caused embryo deaths in rats and rabbits at 128 and 174 times the human exposure, with no birth defects [1]. Neither label has data from pregnant women [1][3].
Population
Rats and rabbits [1][3].
Sources
[3], [1]
Caveats
Animal findings. Both drugs are approved for menopause [1][3].

Claims tested and not found

  1. That elinzanetant cuts measured night waking at 12 weeks. In a sleep laboratory trial, wake time after sleep onset differed from placebo by 0.9 minutes at week 12 [15].
  2. That fezolinetant 30 mg eases sleep disturbance. At week 12 the 30 mg dose did not differ from placebo on the PROMIS sleep scale [8].

Related

Menopausal hormone therapySSRIsSNRIsGabapentinoidsBlack cohoshRed clover

Sources

  1. Veozah (fezolinetant) tablets, prescribing information. DailyMed, US National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=cae9f798-24f9-4580-a4fc-e6c710cbda3c
  2. US Food and Drug Administration. FDA adds warning about rare occurrence of serious liver injury with use of Veozah (fezolinetant) for hot flashes due to menopause. Drug Safety Communication. 2024. https://www.fda.gov/drugs/drug-safety-communications/fda-adds-warning-about-rare-occurrence-serious-liver-injury-use-veozah-fezolinetant-hot-flashes-due
  3. Lynkuet (elinzanetant) capsules, prescribing information. DailyMed, US National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f42884ff-7dff-419c-8a0c-affe2ed73818
  4. Bonga KN, Mishra A, Maiti R, et al. Efficacy and Safety of Fezolinetant for the Treatment of Menopause-Associated Vasomotor Symptoms: A Meta-analysis. Obstetrics & Gynecology. 2024. https://doi.org/10.1097/aog.0000000000005508
  5. de Oliveira HM, Diaz CAV, Barbosa LM, et al. Efficacy and safety of fezolinetant and elinzanetant for vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis. Maturitas. 2025. https://doi.org/10.1016/j.maturitas.2025.108220
  6. AlBarakat MM, AlSamhori JF, Abdelaziz A, et al. Efficacy and safety of fezolinetant for vasomotor symptoms in postmenopausal women: a comprehensive systematic review and meta-analysis of randomized controlled trials. Baylor University Medical Center Proceedings. 2025. https://doi.org/10.1080/08998280.2025.2491894
  7. 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. https://doi.org/10.1016/s0140-6736(23)00085-5
  8. 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. Journal of Clinical Endocrinology & Metabolism. 2023. https://doi.org/10.1210/clinem/dgad058
  9. Afifi E, Abdelaziz Ismail R, Ashraf Aldbash A, 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 Gynecology & Obstetrics. 2026. https://doi.org/10.1002/ijgo.70878
  10. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: OASIS 1 and 2 Randomized Clinical Trials. JAMA. 2024. https://doi.org/10.1001/jama.2024.14618
  11. Panay N, Joffe H, Maki PM, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause: A Phase 3 Randomized Clinical Trial. JAMA Internal Medicine. 2025. https://doi.org/10.1001/jamainternmed.2025.4421
  12. Schaudig K, Wang X, Bouchard C, et al. Efficacy and safety of fezolinetant for moderate-severe vasomotor symptoms associated with menopause in individuals unsuitable for hormone therapy: phase 3b randomised controlled trial. BMJ. 2024. https://doi.org/10.1136/bmj-2024-079525
  13. Shapiro M, Schaudig K, Hirschberg AL, et al. Treating moderate to severe menopausal vasomotor symptoms with fezolinetant: responder analysis of the phase 3b DAYLIGHT study. Menopause. 2025. https://doi.org/10.1097/GME.0000000000002532
  14. Cardoso F, Parke S, Brennan DJ, et al. Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer. New England Journal of Medicine. 2025. https://doi.org/10.1056/nejmoa2415566
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