A Phase 2, Randomized, Placebo-controlled, 12-week, Double-blind Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Chinese Women Suffering From Moderate to Severe 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.
Fezolinetant is approved in several countries to treat hot flashes in women going through menopause. Further studies are needed before it is available in other regions such as Asia.
The goal of this study is to confirm if fezolinetant helps reduce hot flashes in Chinese women going through menopause. This study will also confirm the safety of fezolinetant and how well the women cope with (tolerate) the treatment. The women will take 1 tablet of the study medicine either fezolinetant or placebo once a day for up to 12 weeks. This is decided by chance alone. The placebo looks like fezolinetant but will not have any medicine in it.
Women that want to take part in the study will be given an electronic handheld device with an app to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. During the study, the women will visit the study clinic several times. At each visit they will be asked if they had any medical problems. The women will have general safety checks. At some visits, a breast ultrasound (mammogram), cervical smear, and ultrasound of the womb (uterus) may be done.
The last clinic visit will be 3 weeks after the women take their final tablet of the study medicine (fezolinetant or placebo).

Start Date10 Mar 2025

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT06617455

/ RecruitingPhase 2IIT

Phase 2 Randomized, Cross-over Trial of Fezolinetant for Treatment of Vasomotor Symptoms in Patients Taking Endocrine Therapy (VEnT)

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 on a daily basis. Some women may be able to use the app on their own smartphone. 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. The last clinic visit will be 3 weeks after the women take their last tablet of study treatment (fezolinetant or placebo). After this visit the women will be called twice to check their health. The women will be in the study for about 2 years.

Start Date31 Jul 2024

Sponsor / Collaborator

Astellas Pharma Global Development, 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 Apr 2025·PHYSIOLOGICAL REVIEWS

Kisspeptin and neurokinin B: roles in reproductive health

Article

Author: Koysombat, Kanyada ; Tsoutsouki, Jovanna ; Abbara, Ali ; Dhillo, Waljit S. ; Patel, Aaran H. ; Comninos, Alexander N.

Kisspeptin and neurokinin B (NKB) play a key role in several physiological processes including in puberty, adult reproductive function including the menstrual cycle, as well as mediating the symptoms of menopause. Infundibular kisspeptin neurons, which coexpress NKB, regulate the activity of gonadotropin-releasing hormone (GnRH) neurons and thus the physiological pulsatile secretion of GnRH from the hypothalamus. Outside of their hypothalamic reproductive roles, these peptides are implicated in several physiological functions including sexual behavior and attraction, placental function, and bone health. Over the last two decades, research findings have considerably enhanced our understanding of the physiological regulation of the hypothalamic-pituitary-gonadal (HPG) axis and identified potential therapeutic applications. For example, recognition of the role of kisspeptin as the natural inductor of ovulation has led to research investigating its use as a safer, more physiological trigger of oocyte maturation in in vitro fertilization (IVF) treatment. Moreover, the key role of NKB in the pathophysiology of menopausal hot flashes has led to the development of pharmacological antagonism of this pathway. Indeed, fezolinetant, a neurokinin 3 receptor antagonist, has recently received Food and Drug Administration (FDA) approval for clinical use to treat menopausal vasomotor symptoms. Here, we discuss the roles of kisspeptin and NKB in human physiology, including in the regulation of puberty, menstrual cyclicity, reproductive behavior, pregnancy, menopause, and bone homeostasis. We describe how perturbations of these key physiological processes can result in disease states and consider how kisspeptin and NKB could be exploited diagnostically as well as therapeutically to treat reproductive disorders.

01 Apr 2025·BIOORGANIC CHEMISTRY

Carbene reactive metabolite explains the hepatotoxicity of the hot flashes drug fezolinetant: A DFT investigation

Article

Author: Dixit, Vaibhav A ; Mishra, Gauri ; Nuthi, Anila

Fezolinetant, the first-in-class hot flashes drug, was flagged in September 2024 by US-FDA for liver injury. It is alarming that an FDA-approved drug shows liver toxicity within a year. Fezolinetant's metabolic pathways and metabolites are not disclosed in the FDA label, clinical trial, or other literature reports. This creates a gap in understanding the mechanisms of metabolism and toxicity. In this manuscript, we have investigated novel metabolic pathways that generate reactive metabolites and rationalize hepatotoxicity. Quantum chemical calculations were performed to assess the reactivity of various sites using B3LYP/CC-PVTZ level of theory and H₂O₂ as the model oxidant. A combination of reaction free-energy (ΔG°) ≤ k_BT = 18.5 kcal/mol and docking-based site of metabolism (SOM) to Heme-Fe distance (D_AFe ≤ 6 ± 1.95 Å) criterion was used to assess metabolism feasibilities. Metabolic reactions and sites were considered potential only if both reactivity and accessibility criteria were met. A novel pathway involving Me oxidation at the thiadiazole ring to acid leading to reactive Fezo-carbene metabolite is most feasible (ΔG° and D_AFe: 11 kcal/mol and 6.84 Å). Other feasible pathways include radical formation at the triazolopiperazine ring forming the Fezo-pip-dehydro metabolite (12 kcal/mol and 7.96 Å). The epoxidation, N-oxidation, and S-oxidation of the fluorophenyl, triazolopiperazine, and thiadiazole ring cleavage have minor contributions. Global and local electrophilicity analysis also confirms the higher reactivity potential of Fezo-carbene (ω = 2.77 eV) metabolite. Differences in local electrophilicity (Δω_c⁺) further confirm the higher reactivity of the thiadiazole, fluorophenyl, and triazolopiperazine ring in Fezo-carbene, Fezo-epoxy, and Fezo-pip-dehydro metabolites respectively. Reactions with model nucleophiles (MeOH, H₂O, MeNH₂, and MeSH) show that Fezo-carbene is likely to form thiol adducts. In summary, these results give vital insights into the metabolic mechanisms of fezolinetant's hepatotoxicity and are likely to be useful for the design of less-toxic analogues.

01 Mar 2025·Drug and therapeutics bulletin

Safety update: EMA and FDA warn of liver problems with ▼fezolinetant

Article

116

News (Medical) associated with Fezolinetant

12 Feb 2025

·www.fiercepharma.com

Astellas shifts investment focus to later-stage opportunities amid reprioritization

Despite multiple ongoing programs in novel technologies such as cell and gene therapy, Astellas is trying to spend more energy on less risky modalities. In the last few years, Astellas has invested heavily in novel technologies that are not necessarily the most successful or popular in the industry. With multiple programs now nearing proof-of-concept readouts, yet still “not happy about the pace” of development, Astellas is shifting its focus more to later-stage opportunities, chief strategy officer Adam Pearson said.In 2019, Astellas made big investments in cell and gene therapies with its back-to-back acquisitions of Audentes Therapeutics and Xyphos Biosciences. And last year, the company tacked on collaborations with lentiviral vector delivery specialist Kelonia Therapeutics, allogeneic CAR-T biotech Poseida Therapeutics—which was just bought by Roche—and genomic medicine expert Sangamo Therapeutics.But after a few separate setbacks and an industrywide pullback among large pharmas, Astellas’ cell and gene programs remain in the early stages.“We’re not happy about the pace,” Pearson said on the sidelines of the J.P. Morgan Healthcare Conference in January. “We’d like to go faster, but we have to learn. These are modalities where the learning is part of [the process].”Astellas expects initial clinical readouts for a couple of candidates built on cell and gene technologies in the near future. AT845, an AAV gene replacement therapy designed for Pompe disease, could report data within a year, Pearson said. ASP7317, a regenerative cell therapy for moderate-to-severe geographic atrophy patients, is also “very close” to proof-of-concept results. In cancer cell therapy, Astellas is exploring different technologies, but Pearson said it’s too early to know which ones might work out. For cell therapy, Astellas is focusing on solid tumors and regeneration of the back of the eye. For gene therapy, the Japanese pharma remains hopeful that it can eventually build a presence in neuromuscular disorders because these are the most amenable indications to genetic medicines, he added.“When we enter that market ourselves, it will be difficult to get everything right,” Pearson said. “But one thing we are trying to do is really study what our competitors do and what’s made a success of some of these products and what’s not. What’s helpful for us is that these products are no longer science fiction to doctors.”Despite multiple ongoing programs in cell and gene therapy, Astellas is trying to spend more energy on less risky modalities, the exec said.“We will shift our investment into more somewhat established modalities like bispecifics or immuno-stimulatory ADCs and targeted protein degradation,” Pearson said. “So probably the balance of our investment will be heavier in those areas which are a bit more derisked and where we understand how to make progress.”The company hopes to one day understand how ASP2138, a CLDN18.2xCD3 bispecific, could be different from the company’s newly FDA-approved monoclonal antibody Vyloy. In addition, forthcoming phase 1 data from ASP3082, which targets KRAS G12D mutations, will help Astellas see if its big bet on protein degradation is worthwhile. Astellas will soon have an efficacy readout from a multicohort phase 2 trial for the Pfizer-partnered ADC Padcev to help guide future development of the star drug after its groundbreaking success in bladder cancer.Although antibody-drug conjugates (ADCs) have attracted industry-wide interest and Astellas is one of the few players with a major product in the hot field, Pearson said the modality is not at the moment the focus of the company’s internal pipeline beyond Padcev.Still, if “there was the right, in late-stage, in-licensing opportunity that fitted,” the company might pursue it, Pearson said.That “late-stage” comment reflects a high-level strategy shift at Astellas as it conducts a pipeline review, which led to the recent discontinuation of an early CAR-T prospect aimed at CD20 B-cell lymphomas.“We will continue to go through a prioritization exercise where we will generally shift our resources to focus on slightly later-stage opportunities, whether they be still phase 2 at the moment or life-cycle management, and maybe have room for an in-licensed product to add to that, whilst maintaining kind of a vital level of research in the core areas,” Pearson said.Astellas’ primary focus areas are genetic regulation mostly in neuromuscular diseases, immuno-oncology, blindness and regeneration, and targeted protein degradation. When it comes to acquisitions or licensing, Astellas generally follows those more confined boundaries, even though it doesn’t rule out other opportunities, according to Pearson. The company did branch out recently into women’s health with its hot flash drug Veozah. However, shortly after the drug’s launch, Astellas lowered its peak sales expectations by half to a range of 150 billion Japanese yen to 250 billion Japanese yen ($1 billion to $1.6 billion).“We partly thought about Veozah as a one-off, exciting opportunity to bring a new class to treat an untreated population,” Pearson explained.“We’ve learned a lot from this experience, and we’re really doubling down on the areas where we’ve got this pipeline and a deeper portfolio already,” he added.Veozah, Vyloy and Padcev, together with the geographic atrophy med Izervay and the FLT3 inhibitor Xospata, form the strategic brands in Astellas’ in-market portfolio.The company is undergoing a four-year cost-cutting initiative, which aims to eventually achieve between 120 billion Japanese yen and 150 billion Japanese yen ($800 million to $1 billion) in annual cost savings by the end of its fiscal year 2027 when Pfizer-partnered old prostate cancer drug Xtandi is expected to lose market exclusivity in the U.S.

Phase 1AcquisitionPhase 2ADCCell Therapy

23 Jan 2025

·medcitynews.com

Astellas Exec Talks Dealmaking and Pipeline Strategy in Cancer, Gene Therapy & More - MedCity News

Cancer is well represented in the Astellas Pharma portfolio and pipeline, but the drugmaker has made diversification a key part of its growth strategy. Newer products in its drug lineup include a vision-loss disorder drug and a first-in-class therapy for menopause symptoms. Cell and gene therapies are also a key part of Astellas’s growth strategy, building off of its 2020 acquisition of gene therapy developer Audentes Therapeutics. Within gene therapy, the Tokyo-based company is focused neuromuscular disorders, Chief Medical Officer Tadaaki Taniguci said in an interview last week during the annual J.P Morgan Healthcare Conference in San Francisco. “Our strategy in the past is more developing our capability,” Taniguci said. “We actually acquired Audentes, developing our capabilities toward gene therapy. But now we see that the more important thing for us is to really bring in clinical-phase assets to our pipeline.” Exclusive Improving the Healthcare Financial Experience to Help Care Flow Zelis CEO Amanda Eisel shares her perspective on how the company is solving the problems of a fragmented health financial system to benefit all. By Stephanie Baum The Astellas pipeline is split nearly 50/50 between internally developed drug candidates and assets from acquisitions or external collaborations. Audentes brought AT132, a gene therapy for the rare neuromuscular disease X-linked myotubular myopathy. This program has been beset by setbacks due to patient deaths in the trial. But Audentes also brought programs for two rare other rare disorders, Pompe disease, an inherited disorder that leads to muscle weakness, as well as Friedreich’s ataxia, which causes cardiomyopathy. Both programs are in early clinical development. Astellas is still expanding its gene therapy prospects through deals. Last October, the company paid AviadoBio $50 million for the option to license the biotech’s lead gene therapy, which is in early clinical development for frontotemporal dementia, a neurodegenerative disorder with no FDA-approved treatments. The deal structure is similar to a 2022 agreement that gave Astellas the option to license a Taysha Gene Therapies program for Rett syndrome, a disorder that leads to developmental problems. Phase 1/2 safety and efficacy data for this Rett therapy, TSHA-102, are expected in the first half of this year. Astellas remains willing to strike deals that give it new tools that expand its capabilities in gene therapy, Taniguci said. The company is already developing gene therapies delivered to their bodily destinations carried aboard adeno-associated viruses (AAV). These engineered viruses preferentially go to the liver. In 2021, Astellas began a research collaboration with Dyno Therapeutics focused on discovering novel capsids — the protein shells that envelop a genetic payload — for delivery to skeletal and cardiac muscle. Last month, Astellas began a partnership with Sangamo Therapeutics, securing the right to use one of that biotech’s proprietary capsids to penetrate the brain and reach neuronal targets, which Taniguci said fits with his company’s neuromuscular disease strategy. Penetrating the blood-brain barrier “is the one biggest challenge to overcome to target the [central nervous system],” he said. “So they help us to create much better access to the target organ. We see more platform development together with them to actually create the next generation of gene therapy.” Sponsored Post The Funding Model for Cancer Innovation is Broken — We Can Fix It Closing cancer health equity gaps require medical breakthroughs made possible by new funding approaches. By Eve McDavid - CEO of Mission-Driven Tech In oncology, the company’s top products are Xtandi, a small molecule drug for prostate cancer, and Padcev, an antibody drug conjugate for bladder cancer. A Phase 3 study is evaluating Padcev in combination with the Merck immunotherapy Keytruda as a treatment for muscle-invasive bladder cancer. Data are expected in Astellas’s next fiscal year, which starts on April 1. Additional clinical studies are testing Padcev in non-muscle-invasive bladder cancer and other solid tumors. Astellas is pursuing other approaches to cancer. Its in-house R&D has yielded ASP3082, the company’s lead targeted protein degrader drug for cancer. This drug candidate targets the cancer-driving protein KRAS G12D. At the European Society of Medical Oncology (ESMO) meeting last September, Astellas reported preliminary Phase 1 data showing anti-tumor activity in patients with pancreatic, colorectal, and non-small cell lung cancers. Taniguci noted the results indicate a dose-dependent degradation of the target protein. Astellas will need to show differentiation from other companies developing KRAS G12D-targeting drugs, such as Revolution Medicines and Bristol Myers Squibb, via the pharma giant’s acquisition of Mirati Therapeutics. But Astellas envisions potentially bringing its targeted protein degradation approach to multiple KRAS mutations. “This is a new technology that we started using for KRAS G12D, but we also have a pan-KRAS product coming to the clinic pretty soon,” Taniguci said. “We also started expanding more to other targets. We cannot disclose yet, but [there’s] a lot of excitement.” Astellas’s newest cancer drug is Vyloy, which in October became the first FDA-approved drug targeting claudin 18.2, a protein highly expressed in gastrointestinal cancers. This internally developed drug is a monoclonal antibody. The Astellas pipeline includes another program targeting claudin 18.2, but with a bispecific antibody. This program, ASP2138, is in Phase 1 testing. Women’s health is a newer piece of Astellas’s portfolio coming with the 2023 FDA approval of Veozah, a non-hormonal drug for treating vasomotor symptoms caused by menopause. The first-in-class therapy is a small molecule designed to block neurokinin 3, a receptor that plays a role in regulating body temperature. Last month, the FDA added a black box warning on the product’s label, flagging the risk of severe liver injury. Taniguci said liver toxicity is a known risk that was first observed in clinical trials. None of those cases were severe. In the market, the product has been used by about 100,000 patients. “Liver tox is relatively rare, but sometimes we see the severe cases,” Taniguci said. “That’s why I think it’s important to provide cautions for the patient and physician to use this important medicine. But of course we believe that the benefit/risk balance is really positive. So that’s why we still hear a lot of patients willing to use Veozah in treatment of [vasomotor symptoms].”

Phase 1AcquisitionDrug ApprovalClinical ResultPhase 3

16 Jan 2025

·www.fiercepharma.com

JPM25: Bayer gears up for 'must-win battles' as Xarelto's decline is in full swing, pharma chief says

Bayer is preparing for two potential blockbuster launches in 2025. Although Bayer’s top-selling drug Xarelto lost market exclusivity in most geographies in 2024, the company still predicts it will see strong growth from the pharma business unit beginning in 2027.The optimism is rooted in new launches, Stefan Oelrich, head of Bayer’s pharma division, said Tuesday at the J.P. Morgan Healthcare Conference.Besides label expansions for in-market products such as prostate cancer drug Nubeqa and kidney disease therapy Kerendia, the German pharma is prepping for the potential rollouts of two key drugs: BridgeBio-partnered transthyretin amyloid cardiomyopathy (ATTR-CM) therapy acoramidis and menopause candidate elinzanetant.These launches are what Oelrich called “must-win battles” at Bayer as the Xarelto loss of exclusivity reaches “full swing” in 2025. In the third quarter of 2024, Xarelto already saw its sales drop about 24% to 802 million euros in what Oelrich called “a harbinger” for what to expect of the blood thinner in the following quarters.Bayer in-licensed European rights to acoramidis in April 2024 and secured a positive opinion from the European Medicines Agency in December.In the U.S., following an FDA approval in November and an official launch Dec. 11, BridgeBio this week revealed that it has recorded 430 Attruby (acoramidis) prescriptions for patients with the rare disease.BridgeBio’s early launch progress, which analysts viewed as a strong start, gives Bayer confidence in its own efforts.“It’s certainly a fast-growing, billion-plus type of market opportunity that we will address right where the sweet spot for us is,” Oelrich said. Bayer will leverage its existing commercial infrastructure to support the drug’s launch, which is initially planned for Germany and Switzerland, he said.With elinzanetant, Bayer is handling the drug’s commercialization globally, including the U.S. If approved—the FDA has set a target decision date for July—the drug would go up against Astellas’ Veozah.But, just a few months after an FDA nod in 2023, Astellas slashed its Veozah peak sales projection in half to between 150 billion Japanese yen ($1 billion) and 250 billion yen ($1.6 billion). The Japanese pharma cited insurance coverage as a major challenge to uptake for now, plus a lower-than-expected treatment rate in the overall vasomotor symptoms market. These market-wide insights have led to questions around elinzanetant’s potential.“We see this as a blockbuster candidate,” Oelrich said of elinzanetant. “And, quite frankly, otherwise we shouldn't be launching.”“But I think I mentioned it last year already: This is not a walk in the park, because there is a clear understanding by physicians that [hormone replacement therapy] is an effective treatment,” Oelrich continued. “So we need to find the right place where this is acceptable, both to women, [who] I think are more open to nonhormonals, but also to physicians.” Oelrich argued elinzanetant’s mechanism of action could help it differentiate itself. While Veozah is a neurokinin 3 (NK3) receptor antagonist, elinzanetant is a NK-1 and -3 receptor blocker. Besides, while women’s health is a new area for Astellas, it’s not for Bayer, which has a contraceptive portfolio, including the Mirena device family.“I have personally been part of a launch of HRT,” Oelrich said. “Because we have been a leader in the segment for over 100 years and have been also a leader for many, many years in the women’s health care space in the United States, we’re looking at this, eyes wide open.”

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	United Kingdom	Astellas Pharma, Inc.	18 Dec 2023
Vasomotor symptom	United States	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	United States	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	Canada	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	Czechia	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	Latvia	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	Poland	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	Spain	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	United Kingdom	Astellas Pharma Global Development, Inc.	10 Jul 2019
Liver Injury	Phase 1	United States	Astellas Pharma Global Development, Inc.	02 Sep 2020

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04003142 \| NCT04003389 \| NCT04003155 (SKYLIGHT 1, 2, and 4, Pubmed \| Adv Ther)	Phase 3	Vasomotor symptom	-	Fezolinetant 30 mg	xxwfmbweid(zujfjgiqqb) = 2.9-3.2% ycgfgwskgq (ypgibolvpp ) View more	Positive	30 Dec 2024
				Fezolinetant 45 mg
NCT04451226 (MOONLIGHT 3, Pubmed)	Phase 3	Vasomotor symptom	150	Fezolinetant 30 mg	qeonwpddol(uwajahszxr) = wvupmfuhwa wmppyhaazi (ihkgxsjpqc ) View more	Positive	01 May 2024
NCT05033886 (DAYLIGHT, Corporate Publications) Manual	Phase 3	Vasomotor symptom	453	Fezolinetant	kitnypitbz(jkcddkqkwa) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo ktlvdxwcpd (qpuaqnuwwi ) Met View more	Positive	30 Nov 2023
				Placebo
NCT04003142 \| NCT04003155 (FDA) Manual	Phase 3	Vasomotor symptom	1,022	VEOZAH 45 mg (Trial 1)	usnwhsmyqr(jqzyqhnwaq) = otykkopovd lmuyynrkuw (nxvbzwuitv, 0.05) View more	Positive	12 May 2023
				Placebo (Trial 1)	usnwhsmyqr(jqzyqhnwaq) = zbpwovzyue lmuyynrkuw (nxvbzwuitv, 0.05) View more
NCT04003389 (SKYLIGHT 4, Pubmed)	Phase 3	Vasomotor symptom	1,831	Fezolinetant 30 mg	ikjehygntr(yrlrrqshtt) = hbouofyaiz qeuzhvngoo (nsisakcria )	-	09 Mar 2023
				Fezolinetant 45 mg	oupvbofaex(igrzwgxwos) = ohnpggrihb yxekgbepqd (nznyhufodl, 0 - 2.3)
NCT04003389 (SKYLIGHT 4, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	1,831	placebo (Placebo)	douceycyhk = wbrfjzeucc rxzwagelek (okwdvaddgq, qwvbqrcksd - jmphiwovxv) View more	-	01 Feb 2023
				fezolinetant (Fezolinetant 30 mg)	douceycyhk = zezmzadtfs rxzwagelek (okwdvaddgq, fkbfnroksp - leipdmxitp) View more
NCT04451226 (MOONLIGHT 3, PRNewswire) Manual	Phase 3	Vasomotor symptom	150	Fezolinetant	stbevjkhjs(cuqocklkuy) = generally consistent with previous Phase 3 studies of fezolinetant omajwjiflz (jcuylrvqej )	Positive	04 Sep 2022
NCT04003155 (Skylight 1, CTgov)	Phase 3	Hot Flashes \| Vasomotor symptom	527	placebo (Double-blind Period: Placebo)	itpzuurxne(opyrmuhozs) = tzqieirhct iiiyvxusaz (yhioleidhq, 0.29) View more	-	12 Aug 2022
				fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	vmqdvdklug = mktezypqtn rdvaaqlixg (wpouztychw, vnguspaxga - hsjzewzvey) View more
NCT04003142 (Skylight 2, CTgov)	Phase 3	Menopausal syndrome \| Hot Flashes \| Vasomotor symptom	501	placebo (Double-blind Period: Placebo)	rjswplutcc(ddfezvycwv) = fyxbygsiid nfjqkmabcj (bpjeevhmne, 0.33) View more	-	15 Jun 2022
				Fezolinetant (Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)	wsrtqoujhh(cgxcjuitpj) = vfjmoctchv arljisozsn (qqfooepjig, 4.21) View more
NCT03192176 (Pubmed \| Menopause) Manual	Phase 2	Vasomotor symptom	287	fezolinetant	wjufluoyel(qzleqfwiqp) = -1.9 to -3.5/day wufqokjbbg (bpppefokfj ) View more	Positive	01 Apr 2020
				Placebo

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