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.
NCT04234204 ↗	A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause	Active, not recruiting	Astellas Pharma China, Inc.	Phase 3	2020-03-17	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 (1 tablet) once a day or placebo (1 tablet) 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 24 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 or placebo) during that time. The last 12 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 fezolinetant. Women who take placebo during the first 12 weeks will start taking fezolinetant. At weeks 2, 4, 8, 12, 14, 16, 20 and 24, 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 if they meet the criteria. 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.

Clinical Trial Conditions for fezolinetant

Condition Name

Condition Name for fezolinetant
Intervention	Trials
Hot Flashes	13
Healthy Volunteers	4
Vasomotor Symptoms	2
Androgen Deprivation Therapy	2

Condition MeSH

Condition MeSH for fezolinetant
Intervention	Trials
Hot Flashes	16
Prostatic Neoplasms	2
Renal Insufficiency	1
Osteoporosis, Postmenopausal	1

Clinical Trial Locations for fezolinetant

Trials by Country

Trials by Country for fezolinetant
Location	Trials
United States	113
Japan	31
China	19
United Kingdom	13
Canada	12

Trials by US State

Trials by US State for fezolinetant
Location	Trials
Florida	6
California	5
Texas	5
Maryland	5
Connecticut	4

Clinical Trial Progress for fezolinetant

Clinical Trial Phase

Clinical Trial Phase for fezolinetant
Clinical Trial Phase	Trials
PHASE3	3
PHASE2	8
Phase 3	6

Clinical Trial Status

Clinical Trial Status for fezolinetant
Clinical Trial Phase	Trials
Completed	8
RECRUITING	5
NOT_YET_RECRUITING	5

Clinical Trial Sponsors for fezolinetant

Sponsor Name

Sponsor Name for fezolinetant
Sponsor	Trials
Astellas Pharma Global Development, Inc.	11
Astellas Pharma China, Inc.	3
Astellas Pharma Inc	3

Sponsor Type

Sponsor Type for fezolinetant
Sponsor	Trials
Industry	21
OTHER	7
UNKNOWN	1

Fezolinetant clinical trials update, market analysis, and exclusivity timeline: late-stage pipeline, FDA status, and revenue projection by scenario

Last updated: July 27, 2026

Fezolinetant (Veozah; oral neurokinin-3 [NK3] receptor antagonist) is in late-stage commercialization following FDA approval in 2023 for moderate to severe vasomotor symptoms (VMS) associated with menopause. Commercial trajectory is driven by uptake of NK3-targeted therapy versus legacy hormone therapy (HT) and nonhormonal options (notably fezolinetant’s current branded and generics-free competitive set), with longer-horizon sales exposure shaped by exclusivity, patent estate durability, and payer adoption of once-daily dosing.

What is fezolinetant’s FDA status and Orange Book exclusivity timeline?

Answer: Fezolinetant is FDA-approved (2023) for VMS associated with menopause; exclusivity and patent protection flow from Orange Book-listed patent terms and marketing exclusivities tied to the approved NDA. Launch and generic/biosimilar entry are constrained unless a Paragraph IV ANDA challenges formulation, method-of-use, or process patents listed for the listed drug.

What is the labeled indication and dosing for Veozah?

• Indication: moderate to severe VMS associated with menopause.
• Dose: oral, once daily (commercially marketed as Veozah).

What FDA exclusivities apply (NDA/market exclusivity vs patent term)?

Key drivers for exclusivity:

• Orange Book-listed patents: guide the earliest lawful generic entry date.
• NDA marketing exclusivity: can include three-year/other exclusivity depending on approval pathway and data package.
• Patent term adjustments (PTA) and pediatric exclusivity: can shift effective expiration dates.

Orange Book status: what typically appears and why it matters

For a branded, small-molecule prescription drug:

• At approval, the NDA holder lists patents covering:
  • compound
  • formulation
  • method of use (VMS/milieu tied to NK3 antagonism and clinical endpoints)
  • manufacturing/process
• Generic entry hinges on whether each listed patent is expired or successfully challenged via Paragraph IV.

No Orange Book listing set or expiration dates are provided in the prompt; a complete patent-by-patent exclusivity timeline cannot be stated from the available information.

What clinical trials define fezolinetant’s efficacy and safety profile?

Answer: Fezolinetant’s clinical program centers on menopause-associated VMS reduction and tolerability, with efficacy measured through validated hot flash frequency and severity endpoints and safety assessed across liver enzymes and other system-relevant adverse events consistent with neuroactive small-molecule class effects.

Late-stage pivotal program: what endpoints were used

Commercially relevant clinical endpoints commonly include:

• change from baseline in VMS frequency (hot flashes per day/week)
• proportion achieving clinically meaningful reduction
• symptom recurrence and durability across maintenance periods
• patient-reported outcomes (sleep and quality-of-life measures)

Safety program: what drives prescribing and payer adoption

Safety items that typically affect adoption and access:

• hepatic enzyme monitoring requirements and incidence profile
• class-related adverse events
• discontinuation rates and dose adherence at real-world dosing

Specific trial names, NCT numbers, and numerical results are not supplied in the prompt; a data-anchored update with efficacy figures and safety rates cannot be generated without that source material.

What is the fezolinetant clinical trials update timeline (phase, readouts, and next milestones)?

Answer: The most decision-relevant “update” for investors and competitors is whether new indications, dose refinements, or head-to-head studies are generating additional differentiation after initial approval.

A complete update requires:

• current recruitment status
• top-line readout dates
• conference presentations (e.g., IAS, ACOG, menopause congresses)
• FDA label changes driven by supplemental NDAs

The prompt provides no specific trial registry or press-release milestone set; producing a dated timeline with phase-by-phase readouts would risk inaccuracy.

How strong is the patent estate for fezolinetant, and what patents protect it?

Answer: Fezolinetant’s enforceability will be defined by the Orange Book-listed patents covering compound, formulations, and method of use for NK3 antagonism in menopausal VMS. The strongest risk barrier for generic entry typically comes from method-of-use and formulation patents with the latest expiration dates plus any PTA/extension.

What patent types usually control generic entry for NK3 antagonists

• Compound patents: earliest protection, often expire before formulation and method patents depending on filing/priority.
• Formulation patents: can extend practical exclusivity if solid-state, particle size, or stability constraints remain enforceable.
• Method-of-use patents: can delay generic substitution if they are specific to dosing regimens or clinical outcomes.
• Manufacturing/process patents: can complicate generic supply even if a generic formulation is designed around compound claims.

Patent litigation and regulatory challenge risk

Paragraph IV risk depends on:

• patent lifetime remaining
• claim scope breadth
• enforceability and claim construction outcomes
• whether settlements trigger “no-AG” provisions and shared launch dates

The prompt does not include the Orange Book patent list, expiration dates, or known litigation docket entries; a precise “how strong” assessment cannot be stated without those facts.

When does fezolinetant lose exclusivity, and what generic entry risks exist?

Answer: The earliest lawful generic entry date is the first date when all listed Orange Book patents covering the approved drug are expired or successfully cleared. Market timing is further influenced by potential Paragraph IV settlements that delay launch.

Scenario framework used for market projection

A practical model for projection uses three dates:

1. Earliest Orange Book “at-risk” date (all listed patents expired or cleared)
2. Potential Paragraph IV settlement launch date
3. Market adoption lag (time for payers to move from brand to generic/alternative)

No patent expiration/settlement dates are provided; exclusivity loss and generic entry timing cannot be computed.

What is the competitive landscape for fezolinetant in menopause VMS?

Answer: Fezolinetant competes in nonhormonal VMS therapy alongside other NK receptor-targeting strategies and nonhormonal agents, with the competitive choice shaped by efficacy, tolerability, monitoring burden, and payer formulary placement.

How does fezolinetant compare with alternative nonhormonal VMS therapies?

Decision variables:

• magnitude of hot flash reduction
• onset of effect and durability
• hepatic monitoring and contraindication profile
• patient preference versus HT (avoidance of estrogen-related risks)
• cost and formulary status

No comparative trial results, branded competitor prices, or formulary placement details are supplied in the prompt.

What formulations and dosing strategies are protected for fezolinetant?

Answer: Fezolinetant’s protected IP typically includes oral tablet formulations and potentially specific manufacturing attributes. This can deter “design-around” unless the generic uses a materially different composition or process that avoids patent claim scope.

Formulation patent hooks (what usually gets claimed)

• solid-state form (polymorphs)
• particle size distribution
• excipient selection and ratios
• stability and shelf-life improvements
• dissolution profile and bioavailability optimization

No specific formulation patent numbers or claim scopes are provided; listing what is protected cannot be completed.

What clinical development expansion could extend fezolinetant’s franchise (new indications or combinations)?

Answer: Post-approval franchise extension typically comes from:

• new patient subsets (age, comorbidities)
• longer-term safety studies
• additional menopause-related endpoints
• special populations (renal/hepatic impairment groups)
• combination regimens with other therapies

No post-approval studies or supplemental programs are provided in the prompt.

Fezolinetant market analysis: pricing, payer access, uptake drivers, and channel mix

Answer: Market performance is driven by:

• commercial price and rebates
• payer formulary positioning (preferred vs non-preferred)
• utilization management (prior authorization, step edits)
• persistence and discontinuation rates
• physician preference shift from HT to nonhormonal NK3-targeting

Demand drivers

• growing preference for nonhormonal options in patients who avoid HT
• increased menopause symptom awareness
• improved patient adherence if tolerability and monitoring are manageable

Supply and access constraints

• if safety monitoring increases provider workflow cost, it can slow early uptake
• channel inventory and contracting can affect realized net price

Market segmentation

• age bands (peri vs postmenopause)
• symptomatic severity
• comorbidity-driven selection (e.g., contraindications to HT)

No current realized sales, net price, payer coverage, or channel mix is included in the prompt; numerical market sizing cannot be produced without source inputs.

Fezolinetant revenue projection to 2030: base, upside, and downside scenarios

Answer: Revenue projections depend primarily on (i) sustained new starts, (ii) payer coverage expansion, and (iii) competitive intensity and substitution risk as exclusivity degrades.

A credible projection model requires:

• initial annual prescriptions and trend
• retention/persistence curve
• net price path (gross-to-net)
• generic entry timing and share capture assumptions
• competitive share drift as alternatives launch

The prompt does not provide baseline sales, prescription volumes, or competitor launch schedule; producing numeric revenue forecasts would be speculative.

Projection model structure (non-numeric)

• New starts trajectory: modeled as S-curve tied to formulary expansion.
• Share dynamics: brand retention adjusted for HT substitution and competitor uptake.
• Net price: declines with increased rebate pressure and potential indication expansions.
• Exclusivity: substitution only begins after Orange Book clearance or settlement-driven carveouts.

Key risks to the fezolinetant business case

Answer: Business downside is most sensitive to (1) payer reluctance tied to monitoring and real-world persistence, (2) tighter formulary restrictions, and (3) earlier-than-expected generic-at-risk events if patent challenges reduce effective exclusivity.

Risk categories:

• regulatory: label restrictions or new safety signals
• IP: faster than expected clearing of key Orange Book patents
• commercial: slower adoption due to competitive efficacy comparisons or rebate pressure
• clinical: reduced persistence from tolerability or monitoring burden

Key Takeaways

• Fezolinetant (Veozah) is the marketed NK3 antagonist for moderate to severe menopausal VMS, with commercial adoption governed by payer access, persistence, and monitoring-related workflow friction.
• The controlling timing for generic entry is the Orange Book patent stack plus any Paragraph IV litigation and settlements, not just initial FDA approval timing.
• A rigorous market projection requires baseline sales/prescriptions and the Orange Book patent expiration/settlement dates to model substitution risk; those inputs are not included in the prompt, so numerical forecasts and exact exclusivity dates cannot be stated without risking inaccuracies.

FAQs

1. What is the earliest possible generic launch date for fezolinetant under Orange Book rules?
2. How do Paragraph IV ANDA challenges typically affect fezolinetant’s market timeline?
3. What safety monitoring requirements matter most for fezolinetant persistence in real-world use?
4. Which menopause VMS therapies pose the closest competitive threat to fezolinetant on formulary?
5. What types of formulation patents usually make “design-around” difficult for small-molecule VMS drugs like fezolinetant?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (accessed via FDA Orange Book).
2. FDA. Drug approvals and labeling for Veozah (fezolinetant). (accessed via FDA Drugs@FDA).