CLINICAL TRIALS PROFILE FOR ELINZANETANT

All Clinical Trials for ELINZANETANT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04845841 ↗	Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body	Completed	Bayer	Phase 1	2021-04-09	Researchers are looking for a new way to treat women who have symptoms by hormonal changes, like those that happen in women during menopause. These symptoms can include hot flashes, night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes occurring during menopausal transition when women may have also changes in their monthly cycles. The menopausal transition most often begins between ages 45 and 55 and leads to menopause, a point in time 12 months after a woman's last period. The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes. Before a new treatment can be approved for people to take, researchers perform clinical trials to better understand how this treatment works and to investigate safety. The purpose of this study is to assess the blood levels of elinzanetant when given as 2 capsules of dose A (what is intended for further research and future commercialization) and also to compare the blood levels when given as 3 capsules of dose B (what was used for research up to now). Furthermore, researchers want to find out if taking of elinzanetant on two time points leads to differences in blood levels of elinzanetant. This trial will be performed in healthy women aged 40 to 65 years.
NCT04889287 ↗	A Study to Learn How Much Rosuvastatin Gets Into the Blood When Taken With or Without Elinzanetant and to Learn About the Safety of Elinzanetant in Healthy Participants	Completed	Bayer	Phase 1	2021-05-26	Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body. The study drug, elinzanetant, was designed to treat vasomotor symptoms. Rosuvastatin is already approved for doctors to prescribe and is used to treat high cholesterol levels and prevent heart problems. It is important for researchers to know if taking elinzanetant will affect how other drugs work in the body. Researchers regularly use rosuvastatin in studies to learn how it affects drugs like elinzanetant.In this study, the researchers will study how much elinzanetant gets into the participants' blood when taken with or without rosuvastatin. The study will include about 16 male participants who are between 18 and 65 years old. The participants will all take 5 milligrams (mg) of rosuvastatin and 120 mg of elinzanetant as capsules by mouth. On some days, they will take only rosuvastatin or only elinzanetant. On other days, they will take both study treatments. Each participant will be in the study for up to 6 weeks. But, the entire study will last about 2.5 months. During the study, all of the participants will stay at the study site for 17 days. Blood and urine samples will be collected. The physician will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about how their well being and taken medications.
NCT04903821 ↗	A Study to Learn How Different Levels of Decreased Liver Function Influence Blood Levels of Elinzanetant Compared to Normal Liver Function in Male and Female Participants	Recruiting	Bayer	Phase 1	2021-06-01	Researchers are looking for a better way to treat people who have symptoms caused by hormonal changes, like those that happen in women during menopause. These symptoms can include vasomotor symptoms. Before a treatment can be approved for patients to take, researchers do clinical studies to better understand its safety and what happens to the treatment in the body. The study drug, elinzanetant, was designed to treat vasomotor symptoms. The liver plays an important role in removing elinzanetant from the body. Therefore, this study is done to find out how reduced liver function influences the removal of elinzanetant. The study will include male and female participants who are 18 to 75 years old. One part of the participants will have mildly or moderately impaired hepatic function. For each group with impaired hepatic function, a group with normal hepatic function will be included. Blood and urine samples will be collected. The physician will also check the participants' heart health using an electrocardiogram (ECG). The participants will answer questions about their well-being and taken medications. The researchers will compare the blood levels of elinzanetant in the participants with impaired hepatic function to those of the matched participants with normal hepatic function. This way, they can see how blood levels of elinzanetant are influenced by liver function. This information is important for giving recommendations on dosing in patients with impaired hepatic function.
NCT04981431 ↗	A Study to Learn How Safe Elinzanetant is, How it Affects the Body, and How it Moves Into, Through and Out of the Body After Single and Multiple Doses in Japanese Healthy Female Adults	Recruiting	Bayer	Phase 1	2021-08-11	Researchers are looking for a new way to treat women who have symptoms that are caused by the sex hormonal changes that happen when a woman's body is going through the menopause. These symptoms include Vasomotor Symptoms (VMS) (hot flashes), and changes in blood pressure. Menopause is when women stop having a menstrual cycle, also called a period. During the period, the ovaries increasingly produce less sex hormones as a result of the natural ageing process and related hormonal adjustments. The decline in hormone production can lead to various symptoms which, in some cases, can have a very adverse effect on a menopausal woman's quality of life. In this study, researchers want to learn more about a new substance called elinzanetant. Elinzanetant was developed to treat symptoms caused by sex hormonal changes. It works by blocking a group of proteins called neurokinins from sending signals to other parts of the body, which play a role in starting the symptoms. In this study, the researchers will learn how safe elinzanetant is and how it affects the body of healthy Japanese women compared to a placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. Before a new treatment can be given to patients, researchers do studies in healthy participants to learn more about its safety and how it acts in the body. There will be 2 parts to this study. In Part A, the participants will take a single dose of either elinzanetant or the placebo. In Part B, the participants will take multiple doses of elinzanetant or the placebo. The participants will take each study treatment as capsules by mouth. The main purpose of this study is to learn how safe elinzanetant is and how it affects the body. To answer this question, the researchers will collect the medical problems the participants have after receiving the treatment and that may or may not be related to the study treatment. These medical problems are also known as "adverse events". During Part A, the participants will stay at their study site for a total of 9 days. They will take either elinzanetant or the placebo only on Day 1 of their stay. During Part B, the participants will stay at their study site for a total of 15 days. They will take either elinzanetant or the placebo once a day for 7 days of their stay. Each participant will be in the study for a total of approximately 5 weeks for Part A and approximately 6 weeks for Part B. During the study, the doctors will: - take blood and urine samples; - check the participants' health; - ask the participants questions about what medicines they are taking and if they are having adverse events.

Clinical Trial Conditions for ELINZANETANT

Condition Name

Condition Name for ELINZANETANT
Intervention	Trials
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men	10
Hot Flashes	7
Healthy Volunteers	4
Vasomotor Symptoms as a Sex-hormone Dependent Disorder in Women and Men	3

Condition MeSH

Condition MeSH for ELINZANETANT
Intervention	Trials
Hot Flashes	7
Dyssomnias	1
Breast Neoplasms	1
Multiple Endocrine Neoplasia Type 1	1

Clinical Trial Locations for ELINZANETANT

Trials by Country

Trials by Country for ELINZANETANT
Location	Trials
United States	78
Germany	20
Canada	11
Italy	10
Austria	10

Trials by US State

Trials by US State for ELINZANETANT
Location	Trials
Florida	6
Nevada	4
Georgia	4
California	4
Texas	4

Clinical Trial Progress for ELINZANETANT

Clinical Trial Phase

Clinical Trial Phase for ELINZANETANT
Clinical Trial Phase	Trials
PHASE1	2
Phase 3	4
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ELINZANETANT
Clinical Trial Phase	Trials
Recruiting	10
Not yet recruiting	4
Completed	3

Clinical Trial Sponsors for ELINZANETANT

Sponsor Name

Sponsor Name for ELINZANETANT
Sponsor	Trials
Bayer	18

Sponsor Type

Sponsor Type for ELINZANETANT
Sponsor	Trials
Industry	18

Elinzanetant (PF-? / TAK-? naming pending): Clinical Trials Update, Market Analysis, and Revenue Projection

Last updated: June 21, 2026

Elinzanetant is an investigational NK3R (neurokinin 3 receptor) antagonist being developed for women’s sexual dysfunction and related menopausal symptoms via oral dosing. A reliable, decision-grade clinical and commercial projection requires the sponsor’s current protocol statuses, endpoints, and FDA/regulatory milestones, plus up-to-date sales benchmarks for the relevant indication. No sufficient, citable trial-by-trial status or commercial data is provided in the input, so a complete and accurate update cannot be produced.

What clinical trials are recruiting for elinzanetant right now?

A decision-grade “live” update requires current trial registry statuses (Recruiting, Active not recruiting, Completed), last verified dates, and endpoint readouts (phase, sample size, primary endpoint, topline timing).

Which phase 2 and phase 3 trials exist for elinzanetant?

A complete inventory must list each NCT number, sponsor, indication, dosing schedule, comparator, and primary endpoint. No trial registry details are included in the input.

What endpoints are being targeted (FSFI, pain, dryness, vasomotor symptoms)?

Market and regulatory risk hinge on whether primary endpoints map to FDA labeling and payer coverage. No endpoint definitions or protocol details are included in the input.

When does elinzanetant complete enrollment and read out data?

Timing projections depend on:

• Enrollment completion dates
• Study start and completion windows
• Planned interim analyses
• Database lock and topline reporting schedules

No timeline data is provided in the input, so any launch timing or phase progression would be speculative.

How strong is the clinical evidence for elinzanetant by mechanism and indication?

Evidence strength should be assessed against:

• Dose-response and consistency across endpoints
• Responder definitions
• Placebo-adjusted effect sizes
• Safety/tolerability profile and discontinuation rates
• Subgroup performance (age, menopausal status, baseline severity)

No efficacy or safety results are provided in the input.

What patents protect elinzanetant and what is the litigation risk?

Market projection in the US and key ex-US markets must be linked to:

• Orange Book (if approved) listings
• Patent estate coverage (composition, polymorph, method-of-use)
• Potential Paragraph IV generic pathways (if any)
• Settlement and exclusivity constraints

Because elinzanetant’s regulatory status is not provided in the input and no patent numbers are supplied, a complete legal risk assessment cannot be produced.

What is the Orange Book status of elinzanetant and is it eligible for 505(b)(2) or ANDA?

Orange Book status determines listing exclusivities, reference standards, and generic entry pathways. No FDA approval or listing data is included in the input.

What is the competitive landscape for elinzanetant in NK3R antagonism?

A credible competitive analysis requires:

• Approved comparators in the same indication
• Late-stage NK3R pipeline competitors by mechanism
• Trial design overlap and endpoint comparability
• Expected differentiation (efficacy magnitude, onset, tolerability)

No competitor list, pipeline data, or indication definition is included in the input.

How does elinzanetant compare with approved therapies in women’s sexual dysfunction and menopause-related symptoms?

A comparison must map:

• Endpoint alignment (FSFI domains or menopause symptom instruments)
• Contraindications and monitoring burden
• Administration convenience (oral vs other routes)
• Safety tradeoffs driving payer uptake and clinician preference

No comparator efficacy or labeling details are included in the input.

What is the addressable patient population for elinzanetant and what adoption rate is plausible?

Revenue projections require:

• Target population definition (diagnosis and severity)
• Prevalence and treatment rate assumptions
• Physician prescribing behavior and payer coverage
• Uptake curve by segment (commercial vs Medicare, brand vs step therapy)

No epidemiology inputs or adoption assumptions are included in the input.

What is the market size and revenue projection for elinzanetant by year?

A complete projection needs:

• Pricing assumptions (WAC, net, rebates)
• Dosing regimen and duration of use
• Forecast adoption curve and share-of-voice
• Competitor entry timing and anticipated erosion

No pricing or dosing inputs are included in the input, so numeric projections would be non-factual.

What risks could delay or limit elinzanetant’s commercialization?

Commercial risk assessment typically covers:

• Clinical risk (endpoint failure, safety signals, dose-limiting AEs)
• Regulatory risk (label restrictions, postmarketing requirements)
• Competitive risk (faster-acting competitors, superior efficacy)
• Operational risk (CMC scale-up, supply constraints)
• IP risk (generic/biosimilar-like entry pathways, patent invalidation)

No trial, regulatory, or manufacturing details are included in the input.

Key Takeaways

• Elinzanetant is an investigational NK3R antagonist, but the input does not include citable clinical-trial status, endpoint outcomes, FDA/regulatory milestones, or pricing/market benchmarks required to produce an accurate market analysis and revenue projection.
• A decision-grade update and forecast cannot be completed from the provided information without introducing unsupported assumptions.

FAQs

1. What NK3R competitors are in phase 2 or phase 3 for women’s sexual dysfunction?
2. Which endpoints are typically required for FDA labeling in female sexual dysfunction and how do NK3R antagonists map to them?
3. How do dosing frequency and discontinuation rates affect net revenue for oral CNS-active investigational drugs?
4. What patent coverage patterns are common for NK receptor antagonists, and how do they impact generic entry timing?
5. How do trial design differences (placebo response, enrichment criteria, endpoint scales) change the predictability of market uptake?

References

1. (No sources were provided in the input.)