A Phase 3, Single-arm, 12-week Study to Assess the Efficacy and Safety of Fezolinetant 45 mg in Indian Women Suffering From Moderate to Severe Vasomotor Symptoms (Hot Flashes) Associated With Menopause

This study is for women in India who are going through menopause. They have symptoms including hot flashes and night sweats (also known as vasomotor symptoms or VMS). Fezolinetant is a medicine to treat hot flashes in women going through menopause. It is currently approved in more than 40 countries, including the US and countries in Europe. Further studies are needed before it is approved for use in India. The aim of this study is to confirm if fezolinetant can help reduce hot flashes in Indian women. Women who want to take part in the study will be given an electronic device or use the app on their own smartphone to track their hot flashes and night sweats. The women will record this information before, during and after taking the study treatment. All the women in the study will take 1 tablet of fezolinetant once a day for up to 12 weeks. During the study, the women will visit the study clinic several times. The researchers will collect information about the women's health and ask about their hot flashes and night sweats. At each visit, they will also be asked if they have any medical problems. The women will have a follow up visit 3 weeks after taking their last tablet of study treatment, to collect information about their health and symptoms. Each woman will be in this study for about 5 months.

Start Date31 Oct 2026

Sponsor / Collaborator

Astellas Pharma, Inc.

NCT07606664

/ Not yet recruitingPhase 3IIT

Fezolinetant and Vascular Health and Brain Health

The goal of this clinical trial is to learn whether a study drug called fezolinetant impacts cardiovascular and cognitive health in women who have moderate to severe menopausal hot flashes and night sweats.
Researchers will compare fezolinetant to a placebo. A placebo is a pill that looks like the study drug but does not contain any active medicine. This comparison helps researchers understand whether fezolinetant works better than no treatment.
Participants will:
Be randomly assigned to take either fezolinetant (45 mg) or a placebo once a day for 12 weeks.
Visit the research clinic for regular checkups and tests during the study. Complete tests that measure blood vessel function and cognition.
Participants and study staff will not know which treatment each participant receives during the study.

Start Date25 Sep 2026

Sponsor / Collaborator

University of Pittsburgh

[+1]

NCT07783282

/ Not yet recruitingPhase 1

A Phase 1 Open-label Study to Evaluate the Effect of Enzalutamide, Apalutamide and Bicalutamide on the Pharmacokinetics of Fezolinetant in Male Participants With Prostate Cancer

Hormone therapy, or androgen deprivation therapy (ADT) is a standard way to treat prostate cancer. It works by reducing the amount of testosterone in the body. One of the side effects of hormone therapy is hot flashes. There is an unmet medical need to treat hot flashes in men undergoing hormone therapy for prostate cancer. This study will help researchers understand if hormone therapy (enzalutamide, apalutamide or bicalutamide) affects the way fezolinetant is processed by the body in men with prostate cancer.
The main aim of this study is checking levels of fezolinetant in the blood over time to learn how long it takes to get into the blood, spread through the body and be cleared from the body.
Men with prostate cancer or healthy men can take part. The men with prostate cancer will have already been taking standard hormone therapy (enzalutamide, apalutamide or bicalutamide) for a few months. Men cannot take part if they have recently had major surgery, have had an infection, have a heart condition, or have gut problems. Men with prostate cancer cannot take part if they have other cancers, have recently had certain treatments for prostate cancer, have certain ongoing medical conditions or any chronic disease. This includes any liver problems.
There will be 4 groups in this study:
Group 1 - men with prostate cancer who are taking enzalutamide will be given fezolinetant.
Group 2 - men with prostate cancer who are taking apalutamide will be given fezolinetant.
Group 3 - men with prostate cancer who are taking bicalutamide will be given fezolinetant.
Group 4 - healthy men will only be given fezolinetant.
The men taking part in the study will stay in the clinic for a few days and nights. The men will have nothing to eat or drink for several hours before taking 1 tablet of fezolinetant. Blood samples will be taken and health checks done. During their stay, the men with prostate cancer will continue to be given the standard dose of their hormone therapy. All the men in the study will continue to have regular health checks and will be asked if they have any medical problems. After the men leave the clinic, they will return to the clinic about a week later for a final health check.

Start Date31 Aug 2026

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

132

Literatures (Medical) associated with Fezolinetant

01 Aug 2026·DRUG SAFETY

Liver Safety of the Dual Neurokinin-1/-3 Receptor Antagonist Elinzanetant

Review

Author: Andrade, Raúl J ; Larrey, Dominique ; Trajanovic, Mila ; Horsmans, Yves ; Anderson, Richard A ; Zuurman, Lineke ; Groettrup-Wolfers, Esther ; Lewis, James H

BACKGROUND:

Elinzanetant is a selective dual neurokinin (NK)-1/-3 receptor antagonist for the treatment of moderate-to-severe vasomotor symptoms associated with menopause or caused by endocrine therapy. Elinzanetant has been approved by health authorities in several countries. The occurrence of elevated liver enzymes has been observed in clinical use with NK-3 receptor antagonists, e.g., fezolinetant and pavinetant, with recommendations for liver monitoring in the fezolinetant labeling information. Therefore, a thorough evaluation of the liver safety data from clinical trials with elinzanetant was undertaken.

OBJECTIVE:

To summarize available hepatic safety data from the clinical development program of elinzanetant.

METHODS:

The potential risk of drug-induced liver injury (DILI) associated with elinzanetant was evaluated on the basis of the analysis of 24 phase 1 studies, three phase 2 studies (RELENT-1, SWITCH-1, NIRVANA), and four randomized, placebo-controlled phase 3 studies (OASIS 1‒4). Liver safety assessments were conducted throughout the studies as per protocol. In the phase 3 studies, a liver safety monitoring board (LSMB) performed an independent and blinded review of cases meeting close liver observation criteria, in alignment with US Food and Drug Administration DILI Guidance and the Council for International Organizations of Medical Sciences 2020 consensus on DILI. An independent data and safety monitoring board monitored the general safety of the participants.

RESULTS:

In the clinical program (phases 1‒3), there was no imbalance between the elinzanetant and placebo groups in alanine aminotransferase (ALT) elevations up to 5×, 10×, or 20× the upper limit of normal (ULN). In the pooled studies that included postmenopausal women, during weeks 1‒52 of treatment, ALT or aspartate transaminase (AST) elevations ≥ 3× ULN were observed in 1.2% of participants treated with elinzanetant 120 mg and in 1.0% of participants treated with placebo. In addition, there were no cases meeting Hy's law, and no indication of cholestatic injury. The LSMB assessed two cases on elinzanetant (2 out of 1697 participants, 0.12%) and one case on placebo (1 out of 1028, 0.10%) as probably related to study drug. For the cases on elinzanetant, one participant had a peak ALT level 7.4× ULN and the other had a peak ALT 3.5× ULN. Alkaline phosphatase and total bilirubin levels remained within reference range; both cases were mild and reversible. The peak ALT for the participant on placebo was 3.6× ULN. No case was classified as highly likely or definite.

CONCLUSIONS:

The aggregated phase 1‒3 clinical data, supported by preclinical toxicology and individual case adjudications of participants with elevated liver enzymes, suggest that there is a low risk of liver toxicity for elinzanetant. On the basis of these data, liver test monitoring was considered unnecessary in clinical practice by the LSMB (video abstract available online). Supplementary file2 (MP4 73923 KB).

01 Aug 2026·BREAST

Neurokinin pathway antagonists for vasomotor symptoms in women with breast cancer: focus on elinzanetant and fezolinetant

Review

Author: Arecco, Luca ; Lambertini, Matteo ; Pogoda, Katarzyna

Vasomotor symptoms (VMS) have a major impact on quality-of-life in women with hormone receptor-positive breast cancer receiving adjuvant endocrine therapy. As menopause hormone therapy is contraindicated in this setting, effective non-hormonal treatment options are urgently needed. We performed a focused narrative review of neurokinin (NK) receptor antagonists for VMS, including the OASIS-1-4 program for elinzanetant and the SKYLIGHT, MOONLIGHT, and DAYLIGHT programs for fezolinetant, with emphasis on breast cancer-specific data, safety, drug-drug interactions, and selected special populations relevant to oncology practice. Elinzanetant, a dual NK1/NK3 receptor antagonist approved by the European Medicines Agency and the U.S. Food and Drug Administration, provides the first phase III evidence in the specific cohort of patients with breast cancer receiving endocrine therapy. In the OASIS-4 trial, elinzanetant demonstrated rapid and clinically meaningful reductions in moderate-to-severe VMS, with sustained improvements in sleep and menopause-specific quality of life and a favorable tolerability profile without a signal for clinically significant hepatotoxicity. Fezolinetant, a selective NK3 receptor antagonist approved for menopausal VMS in the general population, has shown robust efficacy across multiple phase III trials; however, its use requires liver function monitoring due to hepatotoxicity, and its role in breast cancer survivors remains under investigation. Safety considerations of NK receptor antagonists include their use alongside CDK4/6 inhibitors. With breast cancer-specific data for elinzanetant and ongoing trials of fezolinetant, these agents will change clinical practice by improving symptom control and adherence to adjuvant endocrine therapy overall.

01 Jun 2026·COMPUTATIONAL BIOLOGY AND CHEMISTRY

Repurposing sulfonamide drugs as anticancer ligands and understanding its properties through density functional theory

Article

Author: Deepa, Palanisamy ; Sundarakannan, Balasubramanian ; Thirumeignanam, Duraisamy

Drug repurposing represents a promising approach towards drug discovery that has the potential to improve patient outcomes and address unmet medical needs. This study attempted to repurpose existing sulfonamide drugs in search of novel anticancer drugs because of their effectiveness in treating bacterial infections. A search was made in DrugBank for Sulfonamide, and 25 drugs with functional groups like SH, OSO, CS, and -S- were chosen for our study. The drug properties, such as dipole moment, volume, polarisability, highest occupied molecular orbital (HOMO), lowest unoccupied molecular orbital (LUMO), and electrostatic potential map, were analysed through a quantum mechanical approach at different functionals: M062X, M06HF, and B3LYP with basis sets (6-31 +G*, LANL2DZ). The electrostatic potential map was analyzed to determine the magnitude, size, and distribution of the electron cloud surrounding the sulfur atoms. Analysis of NBO (Natural Bond Orbital) and NCI (Non-Covalent Interaction) plots confirmed the presence of intramolecular hydrogen bonding in the sulfonamide drugs. Furthermore, the frontier molecular orbitals (HOMO and LUMO) and the band gap were thoroughly examined for all drugs to identify the best electron acceptors and donors. Docking analysis was performed to have a lock-and-key model of 25 sulfonamide drugs with the most promising cancer-targeted protein (1ZZ1): histone deacetylases (HDACs). The best drug orientation (optimal position) was discussed and compared with the control ligand SHH based on the analysis of binding affinity and root mean square deviation (RMSD). Binding affinity of control ligand SHH is -8.1 kcal/mol for the 2nd pose, which matches exactly with 1ZZ1 SHH ligand. The drugs Tolazamide, Fezolinetant, Ensulizole, Taurolidine, Acetohexamide, Isoxicam, Sulfamethizole, Sulfamethoxazole, Sulfapyridine, Sulfaphenazole, and Dodecyl sulphate were observed to exhibit high molecular volume, polarizability, dipole moment and significant HOMO, LUMO values, which are recommended for further quantum mechanical calculations. The findings of this study will be essential for evaluating the properties of sulfonamide drugs from a drugbank using a variety of analyses in order to repurpose them as novel anticancer drugs. Quantum mechanical calculations will be performed on the optimal docking poses in future work. Keywords: Sulfonamide drugs, Docking, Histone deacetylases, Lipinsk's rule, Binding affinity.

154

News (Medical) associated with Fezolinetant

10 Aug 2026

·www.fiercebiotech.com

AbCellera women’s health data top ‘most aggressive upside scenario,’ putting Astellas and Bayer on notice

AbCellera has reported phase 2 results “beyond even the most aggressive upside scenario” that its CEO dared to consider, boosting the biotech’s chances of challenging Astellas and Bayer for a women’s health market. The phase 2 clinical trial compared ABCL635, an antibody targeting NK3R, to placebo in patients with hot flashes caused by menopause. Investigators enrolled 92 postmenopausal women experiencing a mean of about 10 moderate or severe hot flashes per day. By Week 4, the number of moderate or severe hot flashes had fallen by a mean of 8.8 on ABCL635 and by 3.5 on placebo. That statistically significant, placebo-adjusted reduction of 5.3 hit the trial’s primary endpoint. The level of efficacy also cleared the bar set by existing drugs. While cross-trial comparisons can be misleading, AbCellera CEO Carl Hansen, Ph.D., had seen enough to start hyping the program. “We now view ABCL635 as a potential best-in-class non-hormonal therapy with strong differentiation against approved NK3R competitors across all important dimensions, including efficacy, safety, dosing and convenience,” Hansen said on a Monday morning conference call with investors to discuss the data. “We believe ABCL635 is now a highly de-risked program.” Last week, Hansen used AbCellera’s earnings call to set expectations for the readout, with the CEO defining success as a clean safety profile and efficacy comparable to that of the two approved small molecules. The data vaulted over that bar. Astellas linked (PDF) one of the small molecules, Veozah, to placebo-adjusted reductions in hot flash frequency of 2.1 and 2.6 at Week 4 of its two phase 3 trials. Bayer reported (PDF) placebo-adjusted reductions of 3.04 and 3.29 at Week 4 of pivotal studies for its small molecule, Lynkuet. At 5.3, the placebo-adjusted reduction in AbCellera’s trial comfortably cleared the standard set by the incumbents. Veozah and Lynkuet came to market based on evidence of their ability to reduce the frequency and severity of hot flashes. AbCellera’s phase 2 study covered both endpoints, with the Canadian biotech reporting a mean reduction in severity of 1.4 points at Week 4 on ABCL635, compared to 0.3 points for placebo. Again, the placebo-adjusted result compares favorably to data on Veozah and Lynkuet. Analysts shared Hansen’s enthusiasm for the data. The phase 2 results “firmly validate ABCL635 as a potentially best-in-class treatment,” BMO Capital Markets analysts said in a note to investors Monday. ABCL635’s apparent efficacy edge “is likely attributable to the higher dosing/target engagement the asset is able to reach vs. the oral agents due to its wider therapeutic index,” the analysts added. The analysts, who model $2.3 billion in unadjusted peak sales for ABCL635, flagged the safety profile as another positive of the phase 2 readout. While Veozah carries a boxed warning for liver damage, nobody on ABCL635 in the phase 2 trial had elevated liver enzymes or bilirubin values. If replicated in phase 3, the lack of a liver signal could allow approval without the monitoring requirements imposed on Veozah. Investors appeared equally enthused, sending AbCellera's stock up 32% to $9.21 in premarket trading Monday from a Friday closing price of $6.93. Next, AbCellera will collect the Week 12 data and discuss further development with its advisors. The results open up “a wide variety of possibilities of how we might take this forward into phase 3 studies to truly maximize the value of the asset and make sure that ABCL635 is able to demonstrate its differentiation potential,” Sarah Noonberg, M.D., Ph.D., AbCellera’s chief medical officer, told investors.

Phase 2Clinical Result

10 Aug 2026

·firstwordpharma.com

AbCellera's hot flash antibody shows promise for once-monthly dosing

Looking to challenge the daily-dosing standard for non-hormonal treatments of menopause-linked vasomotor symptoms (VMS), AbCellera on Monday shared positive mid-stage data backing its antibody entrant in the space, prompting its stock to jump close to 35% on the news.ABCL635, a long-acting neurokinin-3 receptor (NK-3R) antagonist dosed subcutaneously, met its primary endpoint in the Phase II portion of a Phase I/II trial involving patients with moderate-to-severe VMS, also known as hot flashes.The study enrolled 92 postmenopausal women who were experiencing a mean of 10 hot flashes per day, randomising them to receive either a single 600-mg dose of ABCL635 or placebo.Patients receiving AbCellera's experimental antibody achieved statistically significant reductions in both the frequency and severity of VMS at week 4. The treatment arm experienced, on average, 8.8 fewer moderate and severe events per day from baseline, equal to an 83% reduction in VMS frequency. Those in the placebo group only saw a 33% reduction in VMS frequency — or a 3.5-event reduction per day — for a mean placebo-adjusted treatment difference of 50% (p<0.001).ABCL635 helped tamp down the severity of VMS events as well, achieving a mean 58% reduction of 1.4 points from baseline, compared with a 0.3-point, 12% reduction for placebo. The mean placebo-adjusted treatment difference was 1.1 points, or a 46% reduction (p<0.001). Other secondary measures evaluated ABCL635's impact on sleep and patient-reported scores. According to AbCellera, "meaningful improvements" were seen on scores for both sleep and patient global impression of change (PGI-C).The antibody was well tolerated, with no serious or severe adverse events (AEs), nor any AEs that led to study discontinuation. The most common AEs reported in patients who received a single ABCL635 dose that occurred at a higher rate than the placebo group were headache, fatigue and injection site reaction.Calling the trial results a "significant milestone," Chief Medical Officer Sarah Noonberg said ABCL635 "demonstrated potential best-in-class vasomotor symptom relief over four weeks with a single subcutaneous dose.""These data indicate that ABCL635 could offer menopausal women a well-tolerated, long-acting treatment that has the potential to markedly improve their quality of life," she added.The VMS treatment landscape currently features two non-hormonal options: Bayer's Lynkuet (elinzanetant) and Astellas' Veozah (fezolinetant), both of which are oral drugs dosed once-daily; the former is an NK-1,3R antagonist and the latter blocks NK-3R (see – ViewPoints: Inside Bayer's bet on menopause momentum, and why the health stakes are high and ViewPoints: With incoming rival on horizon, Astellas charts Veozah's voyage to remain market leader).However, hormone therapy recently got a boost for VMS, when the FDA late last year removed boxed warnings for cardiovascular diseases, breast cancer and probable dementia.For more on how physicians are viewing non-hormonal and hormone treatment options for VMS, see Physician Views Results: Doctors likely to stick with hormone therapy habits after FDA's eased warnings, leaving non-hormonal niche intact and Spotlight On: As menopause market gets hormonal again, nonhormonal niche could narrow.

Clinical ResultPhase 2

07 Aug 2026

·newsroom.astellas.com

Submission of New Drug Application for Fezolinetant in Japan for the Treatment of Vasomotor Symptoms Associated with Menopause

TOKYO, August 7, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) confirms it has submitted a New Drug Application (NDA) to Japan's Ministry of Health, Labour and Welfare (MHLW) seeking approval of fezolinetant, a NK3 receptor antagonist, for the treatment of vasomotor symptoms (VMS, also known as hot flushes and sweating) associated with menopause.1,2 The submission is supported by data from clinical studies conducted in Japan including two Phase 3 STARLIGHT™ studies in Japanese women, as well as data from the global clinical development program providing supportive context. If approved, fezolinetant would be the first nonhormonal treatment option in Japan to target the NK3 receptor pathway for women experiencing VMS associated with menopause. Astellas has already reflected the impact from this acceptance in its financial forecast of the current fiscal year ending March 31, 2027. About fezolinetant Fezolinetant is an investigational oral, selective neurokinin 3 receptor (NK3R) antagonist in clinical development in Japan for the treatment of VMS, or hot flushes and night sweats, associated with menopause. It has also been approved in 48 countries for the treatment of moderate to severe VMS associated with menopause. Fezolinetant is designed to block neurokinin B (NKB) binding to NK3R on kisspeptin/neurokinin/dynorphin (KNDy) neurons, a pathway involved in thermoregulation.3,4,5 About STARLIGHT 2 STARLIGHT 2 (NCT06206408) is a 12-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to evaluate the superiority of fezolinetant versus placebo and assess the safety of fezolinetant in Japanese women experiencing VMS associated with menopause. 410 participants were enrolled in the study and randomized to the fezolinetant 30 mg or 45 mg or placebo treatment arms. The primary endpoint is mean change in the frequency of VMS from baseline to week 8, with total treatment duration of 12 weeks. About STARLIGHT 3 STARLIGHT 3 (NCT06206421) is a 52-week randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical study to assess the safety and tolerability of fezolinetant in Japanese women experiencing VMS associated with menopause. 277 participants were enrolled in the study and randomized to the fezolinetant or placebo treatment arms. The primary endpoint is frequency and severity of adverse events through 52 weeks. About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology, and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com. Cautionary Notes In this document, 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 media statement is not intended to constitute an advertisement or medical advice. Contacts for inquiries or additional information: Astellas Pharma Inc. Corporate Communications +81-3-3244-3201 Rachel Norager Lead, Global Brand Communications +6596159221 Rachel.Norager@astellas.com 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 Hill K. The demography of menopause. Maturitas. 1996 Mar;23(2):113-27. doi: 10.1016/0378-5122(95)00968-x. PMID: 8735350 4 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. 5 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.

Phase 2Phase 3NDADrug ApprovalClinical Result

100 Deals associated with Fezolinetant

External Link

KEGG	Wiki	ATC	Drug Bank
D11976	Fezolinetant	-	DB15669

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hot Flashes	United Kingdom	Astellas Pharma, Inc.	14 Dec 2023
Vasomotor symptom	United States	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	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	Ukraine	Astellas Pharma Global Development, Inc.	10 Jul 2019
Menopausal syndrome	Phase 3	United Kingdom	Astellas Pharma Global Development, Inc.	10 Jul 2019
Adenocarcinoma of prostate	Phase 2	United States	Astellas Pharma US, Inc.	14 Jan 2026
Advanced Prostate Carcinoma	Phase 2	United States	Astellas Pharma US, Inc.	14 Jan 2026

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ENDO2026	Not Applicable	Vasomotor symptom	1,778	Fezolinetant	ceevshbria(shwadntjqz) = jerhzljodm hidiwoadsz (yahbxneaxu ) View more	Positive	15 Jun 2026
				Non-hormonal therapies (paroxetine, citalopram, oxybutynin, gabapentin)	-
ENDO 12026 \| ENDO 22026	Phase 3	Vasomotor symptom	3,331	Elinzanetant	jwunyggpir(bfvbdovhvp): RR = 1.35 (95.0% CI, 0.3 - 2.63) View more	Positive	15 Jun 2026
				Fezolinetant
NCT06049797 (OPTION-VMS, ENDO2026)	Phase 4	Vasomotor symptom \| Depressive Disorder \| Anxiety Disorders	656	Fezolinetant	isupzggyxf(zkfgsjpsjz) = vciaievqfe qnmoikabco (xxfjiooccg, -3.48 to -2.10) View more	Positive	14 Jun 2026
				SSRIs/SNRIs	aezwjzgzpa(lctuzwyzmv) = yedcazbzri xymlvtmzue (ysvwwlgdvp ) View more
NCT06440967 (HIGHLIGHT 1, ASCO2026)	Phase 3	Vasomotor symptom \| Hormone receptor positive breast cancer hormone receptor-positive	540	Fezolinetant 45 mg	hftttztknc(kptixojhxf) = jgmoatzwcf etzbjihssn (cbheimgivy )	Positive	29 May 2026
				Placebo	hftttztknc(kptixojhxf) = hflbcyjmsw etzbjihssn (cbheimgivy )
NCT04003142 \| NCT04003155 (SKYLIGHT 1 and 2, Pubmed \| Curr Med Res Opin)	Phase 3	Menopausal symptoms \| Vasomotor symptom	-	Fezolinetant 30 mg	bbfkeytikf(fycidkwmrz) = 39.4% of participants receiving fezolinetant 45 mg vs. 41.3% receiving placebo rzsbzvxsxa (nnhdbprxfg )	Positive	01 Feb 2025
				Fezolinetant 45 mg
NCT04003142 \| NCT04003389 \| NCT04003155 (SKYLIGHT 1, 2, and 4, Pubmed \| Adv Ther)	Phase 3	Vasomotor symptom	-	Fezolinetant 30 mg	nopgqdtzwc(cseoafeffn) = 2.9-3.2% ravhtdwxmg (wbkcoyurfp ) View more	Positive	30 Dec 2024
				Fezolinetant 45 mg
NCT04451226 (MOONLIGHT 3, Pubmed)	Phase 3	Vasomotor symptom	150	Fezolinetant 30 mg	dwocdrknlb(srnnsktlma) = qptjjbrhyy jlbntezahk (dmfjskewof ) View more	Positive	01 May 2024
Skylight 1，Skylight 2 (Pubmed)	-	Hot Flashes	1,022	非唑奈坦	pbpuyuhzbm(cdkgpeevno) = ytzolepptv uqjhcjnvrb (xuavrpufqd ) View more	Positive	01 May 2024
				安慰剂	-
NCT04234204 (Moonlight 1, Pubmed)	-	Hot Flashes	301	非唑奈坦	rjlgpgfqzl(jnfahlroyf): difference = -0.65 (95% CI) View more	Negative	01 May 2024
				安慰剂
NCT05033886 (DAYLIGHT, Corporate Publications) Manual	Phase 3	Vasomotor symptom	453	Fezolinetant	bkevkjcbux(uygyrjcmyl) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo gtikkzoxqt (elglnbpirf ) Met View more	Positive	30 Nov 2023
				Placebo

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