This phase II trial tests how well fezolinetant works in improving vasomotor symptoms (VMS) in breast cancer patients taking endocrine therapy (ET). Anti-hormone treatments are effective for lowering the risk of breast cancer but can cause bothersome VMS, such as hot flashes and night sweats. Fezolinetant inhibits the activity of the neurokinin type 3 receptor and has shown activity against VMS in postmenopausal women. Taking fezolinetant may work well at improving VMS in breast cancer patients taking ET.

Start Date31 Oct 2024

Sponsor / Collaborator

Rogel Cancer Center: University of Michigan

[+1]

NCT06440967 / RecruitingPhase 3

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 and urine tests. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo).

Start Date31 Jul 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.

100 Clinical Results associated with Fezolinetant

100 Translational Medicine associated with Fezolinetant

100 Patents (Medical) associated with Fezolinetant

Literatures (Medical) associated with Fezolinetant

01 Dec 2024·Archives of women's mental health

FDA approved fezolinetant (Veozah): a critical evaluation of its efficacy and safety for menopausal vasomotor symptoms, calling for prospective research

Article

Author: Rani, Payal ; Rani, Priya ; Mansoor, Malaika ; Zehra, Dua

Women going through menopause frequently experience vasomotor symptoms such as hot flashes, night sweats, and sleep disturbances, significantly influencing their quality of life. Hormonal therapy has been demonstrated to be beneficial in treating VMS. However, due to specific restrictions, it is not recommended for every woman. Fezolinetant, a neurokinin 3 antagonist and non-hormonal treatment for severe to moderate VMS, functions by inhibiting neuronal impulses originating from the hypothalamic thermoregulatory center. Current Skylight 2 and 4 trials statistically demonstrate the safety and acceptability of fezolinetant, with relatively few adverse effects reported. Fezolinetant has been shown great potential for treating menopausal-related VMS, supporting its further advancement. However, further investigation is required to thoroughly evaluate its safety, effectiveness, and its impact on sleep patterns.

01 Nov 2024·European Journal of Obstetrics & Gynecology and Reproductive Biology

Non-hormonal pharmacological interventions for managing vasomotor symptoms-how can we help: 2024 landscape

Review

Author: Pertynska-Marczewska, Magdalena ; Pertynski, Tomasz

BACKGROUND:

Vasomotor symptoms (VMS) affect 70% of menopausal women and are considered as hallmark symptoms of the menopausal transition experienced by over three quarters of women and severely by 25% of women. Estrogen withdrawal alone is not fully responsible for the onset of the menopausal vasomotor symptoms and the mechanism of altered thermoregulation appears to be centrally mediated with alterations in hypothalamic neurotransmitters playing a key part. The loss of thermoregulatory control coexists with the altered Kisspeptin- Neurokinin B-Dynorphin-expressing (KNDy) neurons of the arcuate nucleus signaling triggered by menopause.

OBJECTIVE:

Aim of the review was to explore evidence-based non-hormonal pharmacological interventions for treating vasomotor symptoms.

METHODS:

Comprehensive overview of relevant literature.

CONCLUSIONS:

In the population where, hormonal options are contraindicated or not preferred by the patient, it is essential to explore evidence-based non-hormonal pharmacological interventions for treating vasomotor symptoms. The 2024 landscape of available treatments has expanded yet again, arming the providers with an even wider range of possibilities to help their patients. Fezolinetant, is the first NK3R antagonist developed for the purpose of treating hot flashes in menopausal women. NK3R antagonists provide a safe and effective treatment option for managing menopausal women with VMS.

30 Sep 2024·Cureus Journal of Medical Science

Available Treatments and Adjunctive Therapies for Polycystic Ovarian Syndrome (PCOS) Patients of Reproductive Age: A Scoping Review

Review

Author: Garcia, Kristen ; Yagoda, Alexis ; Prol, Barbara ; Costin, Joshua M ; Dressel, Jordan ; Nadolny, Riley ; Shipp, Arianne ; Gandhi, Prachi ; Cochran, Lisa ; Kluglein, Kimberly A ; Peralta, Ria

Polycystic ovarian syndrome (PCOS) impacts the health of women worldwide. It is a condition consisting of dysfunctional cystic ovaries resulting in hormonal imbalance. Many women have symptoms such as infertility, increased production of androgens, and insulin resistance. Barriers to effective treatment of PCOS include issues such as delays in diagnosis and inconsistencies in treatment plans among physicians. Despite the current use of available medications to decrease symptomatology, women with PCOS continue to report a decreased quality of life. Using the electronic databases PubMed, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and ScienceDirect, a scoping review was conducted on the globally available treatments for PCOS. After applying pre-determined inclusion criteria, 41 studies were included in this scoping review. The literature on the available treatments for PCOS revealed a wide range of therapeutics with evidence of reduction of symptoms and/or improvement in fertility status and pathological processes such as insulin resistance, hormone imbalance, obesity, inflammation, and infertility. Dozens of treatment options for PCOS have been identified, including new medications and modifications to existing treatment regimens. The hormonal drug Fezolinetant demonstrated effective suppression of hyperandrogenism. Drugs used to treat diabetes, such as Liraglutide, were found effective for weight loss. Green cardamom, cinnamon, and other supplements proved effective in treating metabolic dysfunction. Alternative approaches, such as osteopathic manipulative therapy and acupuncture, decreased sympathetic tone and androgen levels. This review provides a succinct overview of PCOS therapies that can be used by those with PCOS and their physicians everywhere. With a better understanding of their options, women with PCOS can become more involved in the decision-making process to improve their health. More research is needed on novel therapies that aim to reduce the primary pathogenesis of PCOS.

News (Medical) associated with Fezolinetant

10 Oct 2024

·www.prnewswire.com

Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause

TOKYO, Oct. 10, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that VEOZA™ (fezolinetant)*, its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.1,2 Marci English, Vice President, Head of BioPharma Development, Astellas "Astellas is committed to advancing innovative science, and the data at the World Congress on Menopause further our understanding of how VMS impacts individuals and women's preferences for treatment. In addition, we are excited to share trial design for our recently initiated HIGHLIGHT study assessing fezolinetant for the treatment of moderate to severe VMS in patients with breast cancer taking adjuvant endocrine therapy." Emad Siddiqui, M.D., Vice President, Head of Specialty Therapeutic Area for Medical Affairs, Astellas "We are dedicated to continuing to expand the knowledge about fezolinetant beyond the pivotal trials. Our presentations at the World Congress on Menopause encompass a broad range of clinical and health-related quality of life analyses that further highlight the safety and efficacy of fezolinetant, as well as its positive impact on patient-reported outcomes including sleep and productivity at work." Fezolinetant data will be featured in four oral and two poster presentations: Two oral presentations from the SKYLIGHT 1 and 2 studies focus on patient-reported sleep outcomes and impact on work productivity with fezolinetant (Menopause New Treatments 1 and 2; Monday, Oct. 21, 3:50-5:20 p.m.; A. Cano and R. Nappi, respectively). Two oral presentations from the DAYLIGHT study highlight response and quality of life in women treated with fezolinetant who are unsuitable for hormone therapy (Menopause New Treatments 1; Monday, Oct. 21, 3:50-5:20 p.m.; A. Hirschberg and M. Shapiro, respectively). Poster highlights analyses of clinical and nonclinical data demonstrating no association between fezolinetant treatment and incidence of malignant neoplasm (P073; Sunday, Oct. 20, 7:40-9 p.m.; M. Shapiro). Poster reviews study design for the recently initiated HIGHLIGHT 1 phase 3 clinical study designed to evaluate the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer receiving adjuvant endocrine therapy (P055; Sunday, Oct. 20, 7:40-9 p.m.; P. Briggs). Two additional oral presentations highlight Australian women's preferences for treatment of VMS associated with menopause and results of a literature review designed to identify and characterize concepts relevant to individuals' experiences of VMS with a goal of informing the development of a culturally sensitive self-assessment tool for VMS. *VEOZA: Approved as "VEOZAH ™" in U.S. About the BRIGHT SKY™ Phase 3 Program The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 menopausal women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 menopausal women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe. About DAYLIGHT DAYLIGHT (NCT05033886) is a Phase 3b, randomized, double-blind, placebo-controlled, 24-week study to assess the efficacy and safety of fezolinetant in menopausal women aged 40-65 suffering from moderate to severe VMS and considered unsuitable for hormone therapy. A total of 453 women were enrolled at 69 sites in Canada, Europe and Turkey. About HIGHLIGHT 1™ HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind, Phase 3 clinical study to assess the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites in Europe and Canada. The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. Patients will be treated for 52 weeks with a final evaluation at 55 weeks. About VEOZA™ (fezolinetant) VEOZA (fezolinetant) is a nonhormonal neurokinin 3 (NK3) receptor antagonist indicated in Australia for the treatment of moderate to severe vasomotor symptoms (hot flashes and night sweats) associated with menopause. VEOZA works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron to modulate neuronal activity in the brain's temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats.3,4,5 Important Safety Information The full Australian Product Information and Australian Public Assessment Report (AusPAR) for fezolinetant is available from the Australian Government Therapeutic Goods Administration. About Astellas Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at . Cautionary Notes In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice. References 1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47. 2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed. Waltham, MA: Elsevier, 2014:120. 3 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905. 4 Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27:382-392. 5 Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225. SOURCE Astellas Pharma Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3Drug Approval

13 Sep 2024

·www.biospace.com

Astellas’ Hot Flash Drug Veozah Slapped With Another FDA Warning for Liver Injury

Astellas’ headquarters for the Americas iStock, JHVEPhoto One patient developed elevated liver blood tests after receiving Astellas Pharma’s non-hormonal small molecule blocker, leading the regulator to add a warning to the drug’s label. The FDA on Thursday added a warning to the label of Astellas Pharma ’s hot flash therapy Veozah (fezolinetant), alerting patients and prescribers to a newly documented risk of “rare but serious” liver injury. The new warning was prompted by a postmarketing review of a patient who was taking Veozah and subsequently saw spikes in liver blood test values. The patient also showed signs of liver injury after being treated for around 40 days, according to the regulator. Per Veozah’s updated label , prescribers should test their patients’ blood liver markers more frequently, including monthly screens for the first two months after initiating Veozah, followed by additional tests after three, six and nine months. Doctors and prescribers should also conduct hepatic testing before starting patients on Veozah. In case of signs that could indicate liver problems, patients should stop taking Veozah “immediately” and contact their healthcare professional, according to the FDA. Common symptoms of liver harm include fatigue, jaundice, nausea and vomiting, as well as unusual itching and light-colored stools. Despite being a hit to Veozah’s safety profile, Thursday’s label seems unlikely to substantially hurt Astellas. Jeffries analysts in a note to investors said that the new warning “strengthened Veozah’s label” and that while the additional testing requirements will put more burden on patients, they “may not have much impact on demand overall.” Administered orally, Veozah is a non-hormonal small molecule blocker of the NK3 receptor which plays a part in the signaling cascade that results in the release of specific hormones involved in the menstrual cycle. Veozah specifically acts on neurons in the brain’s thermoregulatory centers, allowing it to reduce the frequency and intensity of hot flashes and night sweats. The FDA approved Veozah in May 2023 for women in menopause. In December 2023, Astellas unveiled more Phase IIIb data for Veozah, touting statistically significant improvements in moderate to severe vasomotor symptoms in patients at 24 weeks compared with placebo. Veozah also reduced sleep disturbance in these patients. At the time, the pharma noted that these findings will help it with reimbursement negotiations in Europe. Bayer is also advancing a non-hormonal competitor to Veozah. Elinzanetant is a small molecule dual inhibitor of the NK1 and NK3 receptors, which the pharma is also positioning as a treatment for moderate to severe vasomotor symptoms in menopause. Bayer won rights to elinzanetant when it bought KaNDy Therapeutics in August 2020 for $425 million upfront . In May 2024, Bayer reported data from its pivotal Phase III OASIS 1 and OASIS 2 studies, demonstrating that elinzanetant significantly lowered the frequency of hot flashes, reduced sleep disturbances and improved menopause-related quality of life.

Clinical ResultDrug ApprovalAcquisitionPhase 3

12 Sep 2024

·www.drugs.com

Drug Safety Communication: FDA Adds Warning About Rare Occurrence of Serious Liver Injury with Use of Veozah (fezolinetant) for Hot Flashes Due to Menopause

Audience: Patient, Health Professional, OBGYN, Endocrinology September 12, 2024 -- The FDA is warning that Veozah ( fezolinetant ), a medicine used to treat hot flashes due to menopause, can cause rare but serious liver injury. If there are signs and symptoms suggesting liver injury, stopping the medicine could prevent worsening liver injury and potentially return liver function to normal. The FDA added a warning about the risk of liver injury to the existing warning about elevated liver function test values and required liver function testing in the prescribing information for Veozah. The FDA made this update after reviewing a post marketing report of a patient with elevated liver function test values and signs and symptoms of liver injury after taking the medicine for about 40 days. The FDA also added new recommendations for patients and health care professionals about increasing the frequency of liver function testing, adding monthly testing for the next 2 months after starting Veozah, and then at months 3, 6, and 9 of treatment as already recommended. The updated prescribing information also instructs patients to stop the medicine immediately and contact the health care professional who prescribed the medicine if signs and symptoms of liver injury occur. BACKGROUND: Veozah (fezolinetant) is a nonhormonal prescription medicine approved in May 2023 to reduce the frequency and severity of moderate to severe hot flashes caused by menopause. The medicine is in a drug class called neurokinin 3 (NK3) receptor antagonists. It works to restore the balance between estrogen hormones and a brain chemical called neurokinin B (NKB) by blocking the activities of the NK3 receptor, which plays a role in the brain’s control of body temperature. RECOMMENDATIONS: Patients and Caregivers Health Care Professionals Related Information Source: FDA Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Drug Approval

100 Deals associated with Fezolinetant

External Link

KEGG	Wiki	ATC	Drug Bank
D11976	Fezolinetant	-	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.

to view more data

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


NCT04451226 (MOONLIGHT 3, Pubmed)	Phase 3	Vasomotor symptom	150	Fezolinetant 30 mg	tgqqafhzht(budfjiarlt) = pytucgqilb mhuwrsdzfc (lapnfveucz ) View more	Positive	01 May 2024
NCT05033886 (DAYLIGHT, Corporate Publications) Manual	Phase 3	Vasomotor symptom	453	Fezolinetant	gfvxhowjje(kvmjcwmexo) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo thgemyprut (bjciomafhl ) Met View more	Positive	30 Nov 2023
				Placebo
NCT04003142 \| NCT04003155 (FDA) Manual	Phase 3	Vasomotor symptom	1,022	VEOZAH 45 mg (Trial 1)	(mxxhepmsag) = ufhxmyxkqt zmqugkqiaj (ybeoazsrta, 0.05) View more	Positive	12 May 2023
				Placebo (Trial 1)	(mxxhepmsag) = gohwpvvuva zmqugkqiaj (ybeoazsrta, 0.05) View more
NCT04003389 (SKYLIGHT 4, Pubmed)	Phase 3	Vasomotor symptom	1,831	Fezolinetant 30 mg	uwllrefzgj(ksqhfbdike) = carjfvtmho wzbulbsatj (ovrwrxkwzk )	-	09 Mar 2023
				Fezolinetant 45 mg	nfocdpthcc(vuywwnfalm) = zcrkobslxg meupnmuchh (qptrgbpbut, 0 - 2.3)
NCT04003389 (SKYLIGHT 4, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	1,831	placebo (Placebo)	upwsgmvevm(qvuedwtjiq) = shmlyohfbn nayckbymyj (zqvifvuohz, kxjayplnft - arqfvfizyw) View more	-	01 Feb 2023
				fezolinetant (Fezolinetant 30 mg)	upwsgmvevm(qvuedwtjiq) = awcsuzxvda nayckbymyj (zqvifvuohz, qazzzuvrqg - cnodilngkw) View more
NCT04451226 (MOONLIGHT 3, PRNewswire) Manual	Phase 3	Vasomotor symptom	150	Fezolinetant	nixwhynhjx(rszvgqdfvq) = generally consistent with previous Phase 3 studies of fezolinetant njnodkjegy (zzyoepttnv )	Positive	04 Sep 2022
NCT04003155 (Skylight 1, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	527	placebo (Double-blind Period: Placebo)	svddiuejrz(rmhfmwqbai) = vtptogprez jgsfemkjwq (qsxynnmbab, uzutvgkvya - drhuzclylq) View more	-	12 Aug 2022
				fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	izmztaiqlq(hmwdmhuocy) = nkmvzytzqf ypzeitywsz (moianyjazf, ltcuqdbqnj - hpvamcitbw) View more
NCT04003142 (Skylight 2, CTgov)	Phase 3	Menopausal syndrome \| Hot Flashes \| Vasomotor symptom	501	placebo (Double-blind Period: Placebo)	nusdqhupni(babtmxnihx) = jypgfzddtm uqmzuhwzfx (xjdxatkleh, ucejdqtnsz - hsykpzmxfv) View more	-	15 Jun 2022
				Fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	ptvcllzonh(wuwlqkldhk) = lxbudwxths wxchyooele (qbirtsoomy, clijwehcir - kuknaamxxg) View more
NCT03192176 (Pubmed \| Menopause) Manual	Phase 2	Vasomotor symptom	287	fezolinetant	ihncdbpqcv(gwlrxzgrpj) = -1.9 to -3.5/day qublgzxewd (dgosxbanqy ) View more	Positive	01 Apr 2020
				Placebo

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