A Randomized, Placebo-controlled, Double-blind, Phase 3 Clinical Study to Investigate the Efficacy and Safety of Fezolinetant for Treatment of Moderate to Severe Vasomotor Symptoms (Hot Flashes) in Women With Stage 0 to 3 Hormone Receptor-positive Breast Cancer Who Are Receiving Adjuvant Endocrine Therapy

One of the standard treatments for women with breast cancer is hormone therapy, but this treatment can cause hot flashes. Hormone replacement therapy, or HRT, is most often prescribed for hot flashes for women in menopause but cannot be given to women on hormone therapy for breast cancer. Fezolinetant, an alternative to HRT, treats hot flashes for women in menopause. As hot flashes happen in the same way for women on hormone therapy for breast cancer, fezolinetant could help these women. In this study, women on hormone therapy for breast cancer who have moderate to severe hot flashes will take part. They will either take fezolinetant or a placebo to treat their hot flashes. The placebo looks like fezolinetant but doesn't have any medicine in it.
The main aim of this study is to confirm if women who take fezolinetant have fewer hot flashes that are less severe compared to women who take the placebo.
Women 18 years or older seeking treatment for hot flashes. They can take part in the study if they have an average of 7 or more moderate to severe hot flashes each day. They are having hormone therapy for breast cancer from stage 0 (cancer cells that have not spread to nearby tissue) up to stage 3+ (the cancer has spread from the breast to the lymph nodes near the breast or the chest wall).
The women will be assigned 1 of 2 study treatments (fezolinetant or placebo) by chance alone. Treatment will be double-blinded. That means that the women in the study and the study doctors will not know who takes which of the study treatments (fezolinetant or placebo). Women who take part in the study will take 1 tablet every day for 52 weeks (1 year). Each woman will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. In the last 10 days before their next clinic visit, the women will record information about their hot flashes. They will also use another device to answer questions about how hot flashes affect their daily life. During the study, the women will visit their study clinic about every 4 weeks for a health check. This will include some blood tests. Some visits will also include a bone scan (called a DXA scan) and a liver ultrasound. Women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo).

Start Date30 Jun 2024

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06206421 / RecruitingPhase 3

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Investigate the Long Term Safety of Fezolinetant in Japanese Women Suffering From Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can't be used by all women or for as long as may be needed.
Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia.
In this study fezolinetant will be used to treat hot flashes in Japanese women going through menopause. This study will confirm the safety of fezolinetant and how well the women tolerate the treatment.
Women will either take fezolinetant or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.
The women will take 1 tablet of the study medicine (fezolinetant or the placebo) once a day for up to 52 weeks.
During the study, the women will visit their study clinic for a check-up about every 4 weeks for up to 52 weeks (1 year). At each visit they will be asked if they had any medical problems. Other checks will include a medical examination and vital signs (temperature, blood pressure and pulse). At some visits, the women will have an ECG to check their heart rhythm and some blood and urine samples will be taken for laboratory tests. During a couple of visits, women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or the placebo).

Start Date22 Feb 2024

Sponsor / Collaborator

Astellas Pharma, Inc.

NCT06206408 / RecruitingPhase 3

A Phase 3, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant in Japanese Women Experiencing Vasomotor Symptoms (Hot Flashes) Associated With Menopause

Hot flashes are the most common reason women going through menopause seek medical attention. Hormone replacement therapy, or HRT, is most often prescribed to treat hot flashes. However, HRT can't be used by all women or for as long as may be needed.
Researchers want to find other ways to treat hot flashes. Fezolinetant is a medicine to treat hot flashes in women going through menopause. Fezolinetant is an approved medicine in the US. Further studies are needed before it is available in other regions such as Asia.
This study will confirm if fezolintant helps reduce the number of hot flashes in Japanese women going through menopause.
Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes. Some women may be able to use the app on their own smartphone. Before the women are assigned a treatment, they will record information about their hot flashes.
Women will either take a lower or higher dose of fezolinetant, or a placebo. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.
The women will take 2 tablets of the study medicine (lower or higher dose of fezolinetant, or the placebo) once a day for up to 12 weeks. They will either take 1 tablet of fezolinetant (higher or lower dose) and 1 placebo tablet, or they will take 2 placebo tablets. The women will continue to record information about their hot flashes on the electronic device or their smartphone.
During the study, the women will visit the study clinic a few times. At each visit they will be asked if they had any medical problems and will use an electronic device at the clinic to answer questions about how the hot flashes affect their daily life. Other checks will include a medical examination, vital signs (temperature, blood pressure and pulse). Some blood and urine samples will be taken for laboratory tests. At some visits, the women will also have an ECG to check their heart rhythm. Women who have a womb (uterus) will also have a test called a transvaginal ultrasound. A probe is gently placed inside the vagina. Sound waves will create a picture of the organs in the pelvis. This will allow the study doctor to look more closely at the uterus and surrounding organs.
The last clinic visit will be 3 weeks after the women take their final tablets of the study medicine (1 tablet of lower or higher dose of fezolinetant and 1 placebo tablet, or 2 placebo tablets).

Start Date16 Feb 2024

Sponsor / Collaborator

Astellas Pharma, Inc.

100 Clinical Results associated with Fezolinetant

100 Translational Medicine associated with Fezolinetant

100 Patents (Medical) associated with Fezolinetant

Literatures (Medical) associated with Fezolinetant

01 Jan 2024·Menopause (New York, N.Y.)

Systematic review and network meta-analysis comparing the efficacy of fezolinetant with hormone and nonhormone therapies for treatment of vasomotor symptoms due to menopause

Review

Author: Kagan, Risa ; Siddiqui, Emad ; Gao, Emily ; Ajmera, Mayank ; Zhao, Angela ; Morga, Antonia ; Patterson-Lomba, Oscar ; Mancuso, Shayna

Abstract:

Importance:

The neurokinin 3 receptor antagonist fezolinetant 45 mg/d significantly reduced frequency/severity of moderate to severe vasomotor symptoms (VMS) of menopause compared with placebo in two phase 3 randomized controlled trials. Its efficacy relative to available therapies is unknown.

Objective:

We conducted a systematic review and Bayesian network meta-analysis to compare efficacy with fezolinetant 45 mg and hormone therapy (HT) and non-HT for VMS in postmenopausal women.

Evidence Review:

Using OvidSP, we systematically searched multiple databases for phase 3 or 4 randomized controlled trials in postmenopausal women with ≥7 moderate to severe VMS per day or ≥50 VMS per week published/presented in English through June 25, 2021. Mean change in frequency and severity of moderate to severe VMS from baseline to week 12 and proportion of women with ≥75% reduction in VMS frequency at week 12 were assessed using fixed-effect models.

Findings:

The network meta-analysis included data from the pooled phase 3 fezolinetant trials plus 23 comparator publications across the outcomes analyzed (frequency, 19 [34 regimens]; severity, 6 [7 regimens]; ≥75% response, 9 [15 regimens]). Changes in VMS frequency did not differ significantly between fezolinetant 45 mg and any of the 27 HT regimens studied. Fezolinetant 45 mg reduced the frequency of moderate to severe VMS events per day significantly more than all non-HTs evaluated: paroxetine 7.5 mg (mean difference [95% credible interval {CrI}], 1.66 [0.63-2.71]), desvenlafaxine 50 to 200 mg (mean differences [95% CrI], 1.12 [0.10-2.13] to 2.16 [0.90-3.40]), and gabapentin ER 1800 mg (mean difference [95% CrI], 1.63 [0.48-2.81]), and significantly more than placebo (mean difference, 2.78 [95% CrI], 1.93-3.62]). Tibolone 2.5 mg (the only HT regimen evaluable for severity) significantly reduced VMS severity compared with fezolinetant 45 mg. Fezolinetant 45 mg significantly reduced VMS severity compared with desvenlafaxine 50 mg and placebo and did not differ significantly from higher desvenlafaxine doses or gabapentin ER 1800 mg. For ≥75% responder rates, fezolinetant 45 mg was less effective than tibolone 2.5 mg (not available in the United States) and conjugated estrogens 0.625 mg/bazedoxifene 20 mg (available only as 0.45 mg/20 mg in the United States), did not differ significantly from other non-HT regimens studied and was superior to desvenlafaxine 50 mg and placebo.

Conclusions:

The only HT regimens that showed significantly greater efficacy than fezolinetant 45 mg on any of the outcomes analyzed are not available in the United States. Fezolinetant 45 mg once daily was statistically significantly more effective than other non-HTs in reducing the frequency of moderate to severe VMS.

Relevance:

These findings may inform decision making with regard to the individualized management of bothersome VMS due to menopause.

15 Dec 2023·Medicine

Efficacy and safety of fezolinetant, a neurokinin-3 antagonist, in treating vasomotor symptoms in postmenopausal women: A systematic review and meta-analysis

Review

Author: Jaffar, Huda ; Bhattarai, Pratik ; Rahman, Ummi Aiman ; Hasanain, Muhammad ; Kashif, Talha Bin ; Rana, Maham ; Usman, Muhammad ; Cheema, Huzaifa Ahmad ; Anjum, Muhammad Umair

Background::

Menopause causes a variety of symptoms such as hot flashes and night sweats. While menopausal hormonal therapy has been used for managing postmenopausal vasomotor symptoms (VMS) for quite a while, it has a considerably poor safety profile.

Objective::

To review and analyze existing data to evaluate the efficacy of the neurokinin-3 antagonist, fezolinetant, in treating postmenopausal VMS and to assess its safety profile.

Methods::

A thorough literature search was performed on PubMed, Cochrane Library, and Google Scholar in compliance with Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020, to find publications on the efficacy of fezolinetant for postmenopausal VMS. Changes in the frequency and severity scores of moderate/severe VMS and changes in the Hot Flash-Related Daily Interference Scale (HFRDIS), Greene Climacteric Scale (GCS), and Menopause-Specific Quality of Life (MENQoL) were the efficacy outcomes. Adverse events, drug-related treatment-emergent adverse effects (TEAEs), drug-related dropouts, hepatotoxicity, endometrial hyperplasia or tumor, and uterine bleeding were all safety outcomes. We used Review Manager 5.4 for pooling risk ratios (RRs) and mean differences (MDs) for dichotomous and continuous outcomes, respectively. A P value of < .05 was considered significant.

Results::

There was a significant reduction in mean daily VMS frequency at weeks 4 and 12 (MD, −2.36; 95% confidence interval [CI], −2.85 to −1.87; P < .00001, for week 12) and also a significant decrease in VMS severity scores in the treatment group. Furthermore, improvements in MENQoL, HFRDIS, and GCS scores were observed. There was no significant difference in adverse events while drug-related TEAEs (RR, 1.21; 95% CI, 0.90–1.63; P = .21) showed a slight increase with fezolinetant. Drug-related dropouts were again similar across the 2 groups. Uterine bleeding had a lower incidence while endometrial events and hepatotoxicity showed a statistically insignificant, increasing trend in the fezolinetant group.

Discussion and implications::

Fezolinetant can be a treatment option for postmenopausal VMS but warns of a risk increase in endometrial hyperplasia or tumors. The heterogeneity in the data being analyzed, short follow-up period, and small sample size in most of the included randomized controlled trials were the greatest limitations, which must be considered in further research and safety profile exploration.

01 Dec 2023·The Journal of pharmacy technology : jPT : official publication of the Association of Pharmacy Technicians

Fezolinetant: A New Nonhormonal Treatment for Vasomotor Symptoms

Review

Author: Onge, Erin St. ; Phillips, Bradley ; Miller, Lisa

Objective: To review the safety, efficacy, and tolerability of fezolinetant for the treatment of vasomotor symptoms associated with menopause. Data Sources: A literature search was conducted through PubMed using the following search terms: fezolinetant, ES259564, SKYLIGHT, vasomotor symptoms, and menopause. Study Selection and Data Extraction: Selected articles included those which described clinical studies of the pharmacology, pharmacokinetics, efficacy, safety, or tolerability of fezolinetant. Data Synthesis: Fezolinetant works by inhibiting neurokinin B from binding to its receptor in the hypothalamus, thereby decreasing the occurrence of vasomotor symptoms. Clinical trials have demonstrated fezolinetant is superior to placebo in decreasing the frequency and severity of vasomotor symptoms. Common adverse effects associated with the use of fezolinetant include headache and gastrointestinal disturbances, as well as elevations in liver transaminase levels. Conclusions: Clinical practice guidelines for the treatment of vasomotor symptoms associated with menopause recommend hormone therapy as the most effective treatment option. Risks associated with hormone use may limit the use of this option in some patients. Neurokinin B inhibitors, like fezolinetant, target the physiologic cause of vasomotor symptoms. With the approval of fezolinetant, as well as elinzanetant which is currently in phase 3 clinical trials, providers and patients have additional nonhormonal treatment options for vasomotor symptoms associated with menopause.

News (Medical) associated with Fezolinetant

17 May 2024

·www.fiercebiotech.com

Bayer lifts lid on pivotal data ahead of filings to challenge Astellas for menopause market

Bayer's work to file for approval of elinzanetant is "running at full steam.” Bayer’s master plan for its OASIS program is coming together, with the German drugmaker posting phase 3 data that suggest it could challenge Astellas for a recently unlocked menopause market. The phase 3 data come from the OASIS 1 and 2 studies. Bayer reported the success of the trials in January, and followed up with news of a hit on a third study in March, but kept the data to itself. With Astellas’ Veozah authorized in the treatment of hot flashes associated with menopause, the details will matter if Bayer wins approval for elinzanetant and starts trying to claim a piece of the market. Bayer used the 2024 American College of Obstetricians and Gynecologists annual meeting to reveal the data behind the hits on the co-primary endpoints. Both studies looked at the effect of elinzanetant on the severity and frequency of hot flashes after four weeks and 12 weeks of oral daily doses. In OASIS 1, Bayer reported mean reductions versus placebo in the frequency of hot flashes of 3.29 at Week 4 and 3.22 at Week 12. The Week 4 and Week 12 reductions in frequency in OASIS 2 were 3.04 and 3.24, respectively. Astellas won approval on the strength of phase 3 trials that linked Veozah to placebo-adjusted reductions (PDF) in hot flash frequency of 2.1 and 2.6 at week 4 and 2.6 and 2.5 at week 12. Comparing data across different clinical trials can give misleading impressions but the available evidence suggests Bayer could be competitive. Across OASIS 1 and 2, Bayer reported mean reductions versus placebo for severity of 0.33 and 0.22 at Week 4 and 0.40 and 0.28 at Week 12. Astellas reported placebo-adjusted reductions in severity of 0.2 and 0.3 at both Week 4 and Week 12. Sleep is an area in which elinzanetant may have an edge over Astellas’ neurokinin-3 (NK-3) antagonist Veozah. Elinzanetant acts on both NK-3 and NK-1, a related receptor that research suggests may have effects on insomnia and mood unrelated to menopause. Bayer reported statistically significant improvements in sleep disturbances and menopause-related quality of life. Astellas has also posted positive sleep data. With three phase 3 successes under its belt, Bayer is preparing to file for approval of elinzanetant. Bayer CEO Bill Anderson said “preparations to obtain first market authorizations are running at full steam” on an earnings call this week. The molecule, which Bayer acquired in its KaNDy Therapeutics buyout, is part of a thin late-phase pipeline that needs to offset anticipated generic erosion of Eylea and Xarelto sales.

Phase 3Clinical ResultAcquisition

17 May 2024

·firstwordpharma.com

Bayer's elinzanetant data heats up rivalry with Astellas drug in menopause market

Bayer has unveiled detailed data from two pivotal trials of its investigational menopause drug elinzanetant, setting the stage for a heated commercial battle with Astellas' already approved Veozah (fezolinetant) in the long-neglected vasomotor symptoms (VMS) market.At the American College of Obstetricians and Gynecologists (ACOG) annual meeting, Bayer presented detailed results from the OASIS 1 and 2 studies, demonstrating that the dual neurokinin-1,3 (NK-1,3) receptor antagonist significantly reduced the frequency and severity of moderate-to-severe hot flashes associated with menopause. A total of about 800 post-menopausal women were enrolled across the two studies.Stacking up to VeozahIn OASIS 1, elinzanetant showed significant mean reductions versus placebo in hot flash frequency of 3.29 at week 4 and 3.22 at week 12. For severity, the reductions were 0.33 and 0.40 at those timepoints, respectively.OASIS 2 yielded similar results, with elinzanetant demonstrating significant mean reductions in frequency of 3.04 at week 4 and 3.24 at week 12, and in severity of 0.22 and 0.29, respectively.The data could position elinzanetant as a strong competitor to Veozah, an NK-3 receptor antagonist approved last year for the treatment of VMS. It is also cleared in Europe under the name Veoza. In the SKYLIGHT 1 and SKYLIGHT 2 trials, Astellas' drug reduced hot flash frequency by 2.07 and 2.55 at week 4 and by 2.53 and 2.55 at week 12. Hot flash severity reductions were about 0.20 and 0.29 across the two SKYLIGHT studies, respectively.While efficacy data suggest a closely matched rivalry, other factors could tilt the scales. Bayer said elinzanetant also met key secondary endpoints in OASIS 1 and 2, significantly improving sleep compared to placebo. Mean change from baseline to week 12 on the PROMIS sleep disturbance measure was 5.58 in OASIS 1 and 4.32 in OSAIS 2 in favour of elinzanetant over placebo.No liver injuryStudy drop-outs due to adverse events were higher in the elinzanetant arms than placebo in both studies (8.5% vs 6.7% in OASIS 1; 6.5% vs 2% in OASIS 2).Liver safety has also been a point of concern for Veozah, which requires liver function testing due to possible increases in hepatic serum transaminase levels. However, researchers said there were "no cases of drug-induced liver injury causally related to elinzanetant" or any incidences of endometrial hyperplasia or malignant neoplasm in either of the OASIS studies, according to the ACOG presentations.In a recent interview with FirstWord, Waljit Dhillo, professor of endocrinology and metabolism at Imperial College London, said "it would definitely be a big difference" if elinzanetant avoids such liver monitoring requirements. "If you can just give a tablet and then go away, that would be attractive."Hitting the NK1 receptor could theoretically provide elinzanetant with better liver safety and less sleep disturbance compared to Veozah, which only targets NK3. However, when asked how optimistic he was about whether elinzanetant could necessitate less liver monitoring, Dhillo noted that since there are no NK3 receptors in the liver, any differentiation in liver safety may come down to differences in the specific molecules rather than their receptor targets.FirstWord recently caught up with Astellas leadership to discuss Veozah, including the concerns regarding liver safety. For more on that interview, see – ViewPoints: Having broken ground in untapped menopause market, Astellas outlines strategy for Veozah as competition heats up.First-mover advantage?"The robust efficacy and favourable safety profile of elinzanetant reinforces its potential as a non-hormonal treatment for women experiencing menopause," said Bayer's R&D head Christian Rommel in a company release. Bayer plans to submit elinzanetant's data to regulatory authorities for marketing approval this year, setting up a commercial clash with Astellas' first-mover advantage. "Our preparations to obtain first-market authorisations are running at full steam," Bayer CEO Bill Anderson stated at the company's earning call this week.Bayer would not disclose elinzanetant's price until the FDA clears it, although some analysts suggest it could cost as much as or more than Veozah, which can cost at least $550 for a month's supply.Commenting on the OASIS readouts, Morgan Stanley analysts said that "although elinzanetant appears slightly more effective than Veozah in reducing symptom frequency over 12 weeks, we do not think this will make a big difference in terms of business. Bayer is due to launch the drug in 2025, giving Veozah a two-year advantage."

Clinical ResultDrug Approval

17 May 2024

·www.pharmamanufacturing.com

Bayer shares phase 3 trial wins for menopause symptom drug

Bayer's investigational compound, elinzanetant, significantly reduced frequency and severity of vasomotor symptoms (hot flashes) associated with menopause in a pair of phase 3 trials . Elinzanetant, which offers non-hormonal treatment, successfully met all four primary endpoints in the OASIS 1 and 2 studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms (VMS) from baseline to week 4 and 12 compared to placebo. In addition, elinzanetant met its key secondary endpoints showing a statistically significant reduction in the frequency of VMS from baseline to week 1 and improved sleep disturbances and menopause-related quality of life compared to placebo. Back in March , Bayer announced positive topline results for the third phase 3 study, OASIS 3, in the OASIS clinical development program. In this study, elinzanetant reduced the frequency of hot flashes from baseline to week 12 compared to placebo. Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist, administered orally once daily. The drug is designed to address VMS by modulating a group of estrogen-sensitive neurons in the hypothalamus region of the brain which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, which disrupts body heat control. Bayer plans to submit the data from the three OASIS studies to regulatory authorities for marketing approval. If approved, elinzanetant will join Astellas' Veozah in the menopause symptoms space. Astellas won approval for the once-daily pill, a neurokinin 3 (NK3) receptor antagonist, a year ago .Veozah was the first non-hormonal treatment for moderate to severe vasomotor symptoms associated with menopause.

Clinical ResultPhase 3Drug Approval

100 Deals associated with Fezolinetant

External Link

KEGG	Wiki	ATC	Drug Bank
D11976	-	-	DB15669

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hot Flashes	GB	Astellas Pharma, Inc.	18 Dec 2023
Vasomotor symptom	US	Astellas Pharma US, Inc.	12 May 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Menopausal syndrome	Phase 3	US	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	CA	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	CZ	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	LV	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	PL	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	ES	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	GB	Astellas Pharma Global Development, Inc.	10 Jul 2019
Liver Injury	Phase 1	US	Astellas Pharma Global Development, Inc.	02 Sep 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05033886 (DAYLIGHT, Corporate Publications) Manual	Phase 3	Vasomotor symptom	453	Fezolinetant	hvwifkdgwm(ohrdgerqjk) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo yzmbchblul (ohpasnjkcb ) Met View more	Positive	30 Nov 2023
				Placebo
NCT04003142 \| NCT04003155 (FDA) Manual	Phase 3	Vasomotor symptom	1,022	VEOZAH 45 mg (Trial 1)	dxcojmdoan(gtssbxpgzl) = ckmskxcmkh tikjurcebz (ijonhxihcz, 0.05) View more	Positive	12 May 2023
				Placebo (Trial 1)	dxcojmdoan(gtssbxpgzl) = mapfapaigg tikjurcebz (ijonhxihcz, 0.05) View more
NCT04003389 (SKYLIGHT 4, Pubmed)	Phase 3	Menopausal symptoms	1,831	Fezolinetant 30 mg	phpewzuowo(ngaqbmtmgs) = kxzagtmlfp cuxvxtrjym (lzkvilhwap )	-	09 Mar 2023
				Fezolinetant 45 mg	jjyfyjqmqz(ninhqnxjio) = oehdlopamv kudjppvtmt (kdzkgsfedj, 0 - 2.3)
NCT04003389 (SKYLIGHT 4, CTgov)	Phase 3	Vasomotor symptom \| Hot Flashes	1,831	placebo (Placebo)	zdbzlmzpaj(sadegwslsd) = meswljxwxj msyxtugslj (ciwtwkgfwj, pwetafgyyq - rqqqssndlv) View more	-	01 Feb 2023
				fezolinetant (Fezolinetant 30 mg)	zdbzlmzpaj(sadegwslsd) = snpkoemtpm msyxtugslj (ciwtwkgfwj, nfhljwbyof - vatmhvcqht) View more
NCT04451226 (MOONLIGHT 3, PRNewswire) Manual	Phase 3	Vasomotor symptom	150	Fezolinetant	fprffzhtyd(sbciqsxoio) = generally consistent with previous Phase 3 studies of fezolinetant oecbbppvmc (ykocunccak )	Positive	04 Sep 2022
NCT04003155 (CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	527	placebo (Double-blind Period: Placebo)	ohiciwuhda(wwijbiyaoy) = vxzbpwftym qgasnjydyk (fxhrpzjvxw, wxiaislsek - zrcihzinxx) View more	-	12 Aug 2022
				fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	xpmhngyueg(wflynzbkxt) = etbffzawmg oaotegwzbq (dqrsxfjddb, hajkmnzrav - xocixpruuu) View more
NCT04003142 (CTgov)	Phase 3	Menopausal syndrome \| Hot Flashes \| Vasomotor symptom	501	placebo (Double-blind Period: Placebo)	btzebcstdr(dhdtfrgjgx) = grwlhqopdd njsebrusjq (vowovvwnrr, danbaijzxk - dxmtbkheml) View more	-	15 Jun 2022
				Fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	bnmyywaspy(mtopfyorfk) = ztqszlnlfv zcorepmpzq (uwquocjzif, ansxrpgopq - rzzfaodvaz) View more
NCT03192176 (Pubmed \| Menopause) Manual	Phase 2	Vasomotor symptom	287	fezolinetant	ygodyhzkmz(wqdxkacyys) = -1.9 to -3.5/day lnmzmhskhc (uwazquimnw ) View more	Positive	01 Apr 2020
				Placebo

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