CLINICAL TRIALS PROFILE FOR FEZOLINETANT

All Clinical Trials for Fezolinetant

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03192176 ↗	A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)	Completed	Astellas Pharma Global Development, Inc.	Phase 2	2017-07-19	This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
NCT03192176 ↗	A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes)	Completed	Ogeda S.A.	Phase 2	2017-07-19	This study determined the effects of different doses and dosing regimens of ESN364 on the frequency and severity of hot flashes. The treatment was administered for 12 weeks to postmenopausal women, aged 40 to 65, suffering at least 50 moderate to severe hot flashes per week.
NCT04003142 ↗	A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2	Completed	Astellas Pharma Global Development, Inc.	Phase 3	2019-07-10	This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes. Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants will take study treatment for 52 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take the same dose. Women who take placebo during the first 12 weeks will start taking fezolinetant. Their dose will be either low dose or high dose fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
NCT04003155 ↗	A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause	Completed	Astellas Pharma Global Development, Inc.	Phase 3	2019-07-10	This study is for women in menopause with moderate to severe hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) The study will compare fezolinetant and placebo after 4 and 12 weeks of dosing. The study will see if fezolinetant reduces the number of hot flashes. And the study will see if fezolinetant reduces the severity of the hot flashes. Women in the study will receive an electronic handheld device at the first study visit. (It is similar to a smart phone.) Each day of the study, study participants will use this to record their hot flashes. Their record for the 10 days before the start of study treatment will be checked. They can remain in the study if their record shows 7 or 8 moderate to severe hot flashes per day (50 or more per week). Next, they will be picked for 1 of the 2 study treatments (fezolinetant or placebo) by chance alone. It is like flipping a coin. The study participants will take study treatment for 52 weeks. The first 12 weeks of study treatment are "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo) during that time. The last 40 weeks of study treatment are "noncontrolled." That means that each study participant and the study doctors know which study treatment that study participant takes during that time. Women who take fezolinetant during the first 12 weeks will continue to take the same dose. Women who take placebo during the first 12 weeks will start taking fezolinetant. Their dose will be either low dose or high dose fezolinetant. At weeks 2, 4, 8, 12, 14, 16 and then once a month, the study participants will go to the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. Study participants will complete questionnaires that are about how hot flashes affect their daily life. Study participants who still have their uterus will have the following 2 tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. This test uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.
NCT04003389 ↗	A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause	Active, not recruiting	Astellas Pharma Global Development, Inc.	Phase 3	2019-07-10	This study is for women in menopause with hot flashes. Menopause, a normal part of aging, is the time of a woman's last period. Hot flashes can interrupt a woman's daily life. The purpose of this study is to find out how safe it is for these women to take fezolinetant long term (up to 52 weeks). To do that, the study will look at the number and severity of the "adverse events." Those are the side effects that study participants have while they are in the study. The study treatments are fezolinetant low dose (1 tablet of fezolinetant and 1 placebo tablet) once a day, fezolinetant high dose (2 tablets of fezolinetant) once a day or placebo (2 tablets) once a day. (Placebo is a dummy treatment that looks like medicine but does not have any medicine in it.) Women in this study will be picked for 1 of the 3 study treatments by chance alone. The study participants will take study treatment for 52 weeks. This study is "double-blinded." That means that the study participants and the study doctors do not know who takes which of the study treatments (fezolinetant low dose, fezolinetant high dose or placebo). At weeks 2 and 4 and then once a month, the study participants will go the hospital or clinic for a check-up. They will be asked about medications, side effects and how they feel. Other checks will include physical exam and vital signs (heart rate, temperature and blood pressure). Blood and urine will be collected for laboratory tests. At some study visits, study participants will complete questionnaires that are about their quality of life. At the first and last study visits, they will have a dual-energy x-ray absorptiometry (DXA for short) test done. To measure bone loss in the hips and spine, DXA creates pictures of the inside of these areas with low-dose x-rays. (The dose is approximately one-tenth of the amount of a normal chest x-ray.) Study participants who still have their uterus will have 2 more tests done at the first and last study visits. One of the 2 tests is endometrial biopsy. This test involves removing a small amount of tissue from the inside lining of the uterus. The tissue is then checked under a microscope. The other test is transvaginal ultrasound. It uses sound waves to create pictures of the organs in the pelvis. The sound waves are transmitted by a probe (transducer), which is placed inside the vagina. Study participants may have a screening mammogram done at the first and/or last study visit. A mammogram is an x-ray picture of the breasts used to screen for breast cancer. Study participants who did not have this test done in the last 12 months will have it done at the first study visit. They will have it done at the last study visit if they are due for their screening mammogram and their own doctor agrees. The last check-up at the hospital or clinic will be 3 weeks after the last dose of study treatment.

Clinical Trial Conditions for Fezolinetant

Condition Name

Condition Name for Fezolinetant
Intervention	Trials
Hot Flashes	8
Healthy Volunteers	4
Healthy Subjects	1
Hepatic Impairment	1

Condition MeSH

Condition MeSH for Fezolinetant
Intervention	Trials
Hot Flashes	9
Liver Diseases	1
Renal Insufficiency	1

Clinical Trial Locations for Fezolinetant

Trials by Country

Trials by Country for Fezolinetant
Location	Trials
United States	108
United Kingdom	10
Canada	9
Czechia	5
Poland	4

Trials by US State

Trials by US State for Fezolinetant
Location	Trials
Florida	6
Texas	5
Maryland	5
California	5
Utah	4

Clinical Trial Progress for Fezolinetant

Clinical Trial Phase

Clinical Trial Phase for Fezolinetant
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	3
Phase 1	5

Clinical Trial Status

Clinical Trial Status for Fezolinetant
Clinical Trial Phase	Trials
Completed	8
Active, not recruiting	3
Not yet recruiting	2

Clinical Trial Sponsors for Fezolinetant

Sponsor Name

Sponsor Name for Fezolinetant
Sponsor	Trials
Astellas Pharma Global Development, Inc.	9
Astellas Pharma China, Inc.	3
Ogeda S.A.	2

Sponsor Type

Sponsor Type for Fezolinetant
Sponsor	Trials
Industry	15

Fezolinetant: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction to Fezolinetant

Fezolinetant, marketed as VEOZAH™, is an investigational oral, nonhormonal compound developed by Astellas Pharma Inc. for the treatment of vasomotor symptoms (VMS) associated with menopause and other conditions. Here, we delve into the current status of clinical trials, market analysis, and future projections for this drug.

Mechanism of Action

Fezolinetant works by blocking neurokinin B (NKB) signaling, which normalizes the activity of KNDy (kisspeptin/NKB/dynorphin) neurons. This modulation affects the temperature control center in the brain, thereby reducing the frequency and severity of VMS, such as hot flashes[2].

Clinical Trials Update

Phase 3 Trials for Menopause-Related VMS

Several Phase 3 trials are underway to evaluate the efficacy and safety of fezolinetant for VMS associated with menopause.

• DAYLIGHT Study: This study generated positive topline results, evaluating the 24-week efficacy and safety of fezolinetant in women considered unsuitable for hormone therapy. The data from this study will primarily support health technology assessment (HTA) and reimbursement dossiers in Europe[3].
• STARLIGHT 2 and STARLIGHT 3: In Japan, these two Phase 3 clinical studies are evaluating fezolinetant. STARLIGHT 2 is a 12-week randomized, double-blind, placebo-controlled study assessing the superiority of fezolinetant versus placebo, while STARLIGHT 3 is a 52-week study evaluating the long-term safety and tolerability of fezolinetant[4].

Phase 3 Trial for Breast Cancer Patients

The HIGHLIGHT 1 trial (NCT06440967) has begun enrollment, investigating fezolinetant for the treatment of moderate to severe VMS in patients with breast cancer receiving adjuvant endocrine therapy. This trial is significant because currently, there are no approved treatments for VMS in these patients[1].

Market Analysis

Market Forecast

The market for fezolinetant is expected to grow significantly over the next decade. Comprehensive market forecasts from 2023 to 2032 indicate a substantial increase in the market size for vasomotor symptoms across the seven major markets (7MM), including the United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan[5].

• Market Size: The forecasted sales data suggest that the market for fezolinetant will expand due to extensive research and incremental healthcare spending. This growth will enable drug manufacturers to penetrate the market more effectively[5].

Competitive Landscape

Fezolinetant faces competition from other emerging therapies for VMS. The launch of late-stage emerging therapies in the near future is expected to significantly impact the market, presenting both challenges and opportunities for fezolinetant[5].

• SWOT Analysis: The market analysis includes a detailed SWOT analysis, highlighting the strengths, weaknesses, opportunities, and threats associated with fezolinetant. This analysis provides insights into the competitive landscape and the potential dominance of fezolinetant in the market[5].

Regulatory Milestones

Fezolinetant was approved by the U.S. Food and Drug Administration (FDA) in May 2023 for the treatment of moderate to severe VMS caused by menopause. Astellas is pursuing regulatory approval in several other countries and regions, including Europe[3].

Market Projections

Forecasted Sales

The forecasted sales data from 2023 to 2032 indicate a robust growth trajectory for fezolinetant. Here are some key projections:

• United States: The market size for fezolinetant in the United States is expected to increase significantly over the forecast period.
• EU4 and UK: Similar growth is anticipated in Germany, France, Italy, Spain, and the United Kingdom.
• Japan: The Japanese market is also projected to see substantial growth, driven by the ongoing Phase 3 trials and anticipated regulatory approvals[5].

Future Market Scenario

The future market scenario for fezolinetant looks promising due to several factors:

• Extensive Research: Ongoing and planned clinical trials will provide additional efficacy and safety data, supporting further regulatory approvals and market penetration.
• Incremental Healthcare Spending: Increased healthcare spending globally is expected to expand the market size for treatments of VMS.
• Novel Approaches: Fezolinetant’s unique mechanism of action, targeting NKB signaling, positions it as a novel approach in the treatment of VMS, potentially giving it a competitive edge[5].

Key Takeaways

• Clinical Trials: Fezolinetant is in various Phase 3 trials for VMS associated with menopause and breast cancer, with positive topline results from the DAYLIGHT study.
• Market Growth: The market for fezolinetant is projected to grow significantly from 2023 to 2032 across major markets.
• Regulatory Approvals: FDA approval in the U.S. and ongoing regulatory pursuits in other regions highlight the drug's potential for widespread use.
• Competitive Landscape: Fezolinetant faces competition but its unique mechanism and positive clinical data position it strongly in the market.

FAQs

What is the mechanism of action of fezolinetant?

Fezolinetant works by blocking neurokinin B (NKB) signaling, normalizing KNDy neuron activity, and modulating the temperature control center to reduce VMS[2].

What are the current clinical trials for fezolinetant?

Fezolinetant is in Phase 3 trials for VMS associated with menopause (DAYLIGHT, STARLIGHT 2, and STARLIGHT 3) and for patients with breast cancer receiving adjuvant endocrine therapy (HIGHLIGHT 1)[1][3][4].

Has fezolinetant received any regulatory approvals?

Yes, fezolinetant was approved by the FDA in May 2023 for the treatment of moderate to severe VMS caused by menopause. Regulatory approvals are being pursued in other regions[3].

What is the projected market size for fezolinetant?

The market size for fezolinetant is expected to grow significantly from 2023 to 2032 across the 7MM, driven by extensive research and incremental healthcare spending[5].

How does fezolinetant compare to other treatments for VMS?

Fezolinetant offers a novel, nonhormonal approach by targeting NKB signaling, which differentiates it from other treatments and positions it competitively in the market[2].

What are the potential challenges for fezolinetant in the market?

Fezolinetant faces competition from other emerging therapies for VMS, and the launch of late-stage emerging therapies may impact its market share[5].

Sources

1. Targeted Oncology: "Fezolinetant Trial for Hot Flashes in Patients With HR+ Breast Cancer Starts Enrollment"
2. Market Research: "Fezolinetant Emerging Drug Insight and Market Forecast – 2032"
3. Astellas Newsroom: "Phase 3b Trial of Fezolinetant Shows Positive Topline Results for Treatment of VMS Due to Menopause"
4. Astellas: "Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS in Japanese Women"
5. Research and Markets: "Fezolinetant Emerging Drug Insight and Market Forecast - 2032"