Hot Flashes Drug Pipeline Analysis Report 2025
Description
Hot flashes are sudden sensations of heat, often accompanied by sweating and flushing, primarily affecting menopausal women. They account for around half of women aged 40 to 64 worldwide, significantly impacting quality of life. There is a high unmet clinical need for better therapies, as current treatment options, such as hormone replacement therapy, may carry risks. The growing focus on non-hormonal hot flashes therapeutics, including neurokinin receptor antagonists and selective estrogen receptor modulators, is driving pipeline growth.
Report Coverage
The Hot Flashes Drug Pipeline Insight Report by Expert Market Research gives comprehensive insights into hot flashes therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for hot flashes. The hot flashes report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hot flashes pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with hot flashes treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to hot flashes.
Hot Flashes Drug Pipeline Outlook
Hot flashes are sudden, intense feelings of heat, often accompanied by sweating, flushing, and chills. They occur due to hormonal fluctuations, particularly the decline in estrogen during menopause. This affects the hypothalamus, the body’s temperature regulator, leading to vasodilation and excessive heat dissipation, causing discomfort and disruption in daily life.
Hot flashes treatment includes hormone replacement therapy (HRT), the most effective option, but it carries potential risks. Non-hormonal alternatives like SSRIs, gabapentinoids, and neurokinin receptor antagonists (e.g., Fezolinetant) offer relief. Lifestyle modifications, cognitive behavioral therapy, and herbal supplements such as black cohosh also help manage symptoms with varying efficacy.
Hot Flashes Epidemiology
Hot flashes affect 75%-80% of menopausal women in the United States and 24% of Japanese women, peaking at ages 50-54. Globally, over 50% of women aged 40–64 experience vasomotor symptoms (VMS), including hot flashes. In Europe, 31%-52% of postmenopausal women report moderate to severe VMS. Advancements in hot flashes therapeutic products, including neurokinin receptor antagonists, are driving pipeline growth.
Hot Flashes – Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of hot flashes drug candidates based on several segmentations, including:
By Phase
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis , phase II covers a major share of the total hot flashes clinical trials.
Hot Flashes – Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the hot flashes pipeline analysis include small molecules, monoclonal antibodies, peptides, neurokinin receptor antagonists, and gene therapies. The hot flashes report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hot flashes.
Hot Flashes Clinical Trials Therapeutic Assessment – Competitive Dynamics
The EMR report for the hot flashes drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hot flashes therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hot flashes clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for hot flashes. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of hot flashes drug candidates.
Drug: Fezolinetant
Fezolinetant, developed by Astellas Pharma Inc., is being evaluated in a Phase III study to assess its efficacy and safety in reducing hot flashes in Japanese menopausal women, compared to a placebo. The study is expected to be completed by March 2026, with around 390 participants enrolled.
Drug: Elinzanetant
Elinzanetant, an investigational drug developed by Bayer, is being studied in the Phase III OASIS-4 trial to evaluate its efficacy and safety in treating hot flashes caused by anti-cancer therapy in women with or at high risk for hormone-receptor-positive breast cancer. The drug is a selective neurokinin-3 (NK3) receptor antagonist designed to reduce hot flashes without affecting hormone levels. The study, involving approximately 473 participants, is expected to be completed by December 2026 and compares Elinzanetant to a placebo.
Drug: NOE-115
NOE-115 is being evaluated in a Phase 2a study to assess its safety, tolerability, and preliminary efficacy in women experiencing moderate to severe vasomotor symptoms (hot flashes) due to menopause. The study, involving approximately 24 participants, is expected to be completed by April 30, 2025. This multicenter, open-label trial seeks to assess NOE-115 as a potential therapeutic product for hot flashes.
Reasons To Buy This Report
The Hot Flashes Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for hot flashes. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into hot flashes collaborations, regulatory environments, and potential growth opportunities.
Key Questions Answered in the Hot Flashes – Pipeline Insight Report
Hot Flashes Epidemiology Forecast
Vasomotor Symptoms of Menopause Drug Pipeline Analysis
Global Clinical Trials Market
Report Coverage
The Hot Flashes Drug Pipeline Insight Report by Expert Market Research gives comprehensive insights into hot flashes therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for hot flashes. The hot flashes report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The hot flashes pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with hot flashes treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to hot flashes.
Hot Flashes Drug Pipeline Outlook
Hot flashes are sudden, intense feelings of heat, often accompanied by sweating, flushing, and chills. They occur due to hormonal fluctuations, particularly the decline in estrogen during menopause. This affects the hypothalamus, the body’s temperature regulator, leading to vasodilation and excessive heat dissipation, causing discomfort and disruption in daily life.
Hot flashes treatment includes hormone replacement therapy (HRT), the most effective option, but it carries potential risks. Non-hormonal alternatives like SSRIs, gabapentinoids, and neurokinin receptor antagonists (e.g., Fezolinetant) offer relief. Lifestyle modifications, cognitive behavioral therapy, and herbal supplements such as black cohosh also help manage symptoms with varying efficacy.
Hot Flashes Epidemiology
Hot flashes affect 75%-80% of menopausal women in the United States and 24% of Japanese women, peaking at ages 50-54. Globally, over 50% of women aged 40–64 experience vasomotor symptoms (VMS), including hot flashes. In Europe, 31%-52% of postmenopausal women report moderate to severe VMS. Advancements in hot flashes therapeutic products, including neurokinin receptor antagonists, are driving pipeline growth.
Hot Flashes – Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of hot flashes drug candidates based on several segmentations, including:
By Phase
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
- Small Molecules
- Monoclonal Antibodies
- Peptides
- Neurokinin Receptor Antagonists
- Gene Therapies
- Oral
- Parenteral
- Others
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis , phase II covers a major share of the total hot flashes clinical trials.
Hot Flashes – Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the hot flashes pipeline analysis include small molecules, monoclonal antibodies, peptides, neurokinin receptor antagonists, and gene therapies. The hot flashes report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for hot flashes.
Hot Flashes Clinical Trials Therapeutic Assessment – Competitive Dynamics
The EMR report for the hot flashes drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed hot flashes therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in hot flashes clinical trials:
- Astellas Pharma Inc.
- Noema Pharma AG
- Bayer
- NeuTherapeutics
- Hansoh BioMedical R&D Company
- AbbVie
- Novartis
- Pfizer
- Novo Nordisk
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for hot flashes. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of hot flashes drug candidates.
Drug: Fezolinetant
Fezolinetant, developed by Astellas Pharma Inc., is being evaluated in a Phase III study to assess its efficacy and safety in reducing hot flashes in Japanese menopausal women, compared to a placebo. The study is expected to be completed by March 2026, with around 390 participants enrolled.
Drug: Elinzanetant
Elinzanetant, an investigational drug developed by Bayer, is being studied in the Phase III OASIS-4 trial to evaluate its efficacy and safety in treating hot flashes caused by anti-cancer therapy in women with or at high risk for hormone-receptor-positive breast cancer. The drug is a selective neurokinin-3 (NK3) receptor antagonist designed to reduce hot flashes without affecting hormone levels. The study, involving approximately 473 participants, is expected to be completed by December 2026 and compares Elinzanetant to a placebo.
Drug: NOE-115
NOE-115 is being evaluated in a Phase 2a study to assess its safety, tolerability, and preliminary efficacy in women experiencing moderate to severe vasomotor symptoms (hot flashes) due to menopause. The study, involving approximately 24 participants, is expected to be completed by April 30, 2025. This multicenter, open-label trial seeks to assess NOE-115 as a potential therapeutic product for hot flashes.
Reasons To Buy This Report
The Hot Flashes Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for hot flashes. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into hot flashes collaborations, regulatory environments, and potential growth opportunities.
Key Questions Answered in the Hot Flashes – Pipeline Insight Report
- Which companies/institutions are leading the hot flashes drug development?
- What is the efficacy and safety profile of hot flashes pipeline drugs?
- Which company is leading the hot flashes pipeline development activities?
- What is the current hot flashes commercial assessment?
- What are the opportunities and challenges present in the hot flashes drug pipeline landscape?
- What is the efficacy and safety profile of hot flashes pipeline drugs?
- Which company is conducting major trials for hot flashes drugs?
- Which companies/institutions are involved in hot flashes collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in hot flashes?
Hot Flashes Epidemiology Forecast
Vasomotor Symptoms of Menopause Drug Pipeline Analysis
Global Clinical Trials Market
Table of Contents
200 Pages
- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Hot Flashes
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Hot Flashes
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Hot Flashes: Epidemiology Snapshot
- 5.1 Hot Flashes Incidence by Key Markets
- 5.2 Hot Flashes – Patients Seeking Treatment in Key Markets
- 6 Hot Flashes: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Hot Flashes: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Hot Flashes, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Hot Flashes Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Hot Flashes Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
- 10.1 Comparative Analysis for Late-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: Fezolinetant
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Drug: Elinzanetant
- 10.2.3 Other Drugs
- 11 Hot Flashes Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: NOE-115
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Other Drugs
- 12 Hot Flashes Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Drug 1
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Other Drugs
- 13 Hot Flashes Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
- 13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
- 13.1.1 Study Type
- 13.1.2 Recruitment Status
- 13.1.3 Company
- 13.1.4 Funder Type
- 13.2 Product Level Analysis*
- 13.2.1 Drug 1
- 13.2.1.1 Product Description
- 13.2.1.2 Trial ID
- 13.2.1.3 Sponsor Name
- 13.2.1.4 Study Type
- 13.2.1.5 Drug Class
- 13.2.1.6 Eligibility Criteria
- 13.2.1.7 Study Record Dates
- 13.2.1.7.1 First Submitted
- 13.2.1.7.2 First Posted
- 13.2.1.7.3 Last Update Posted
- 13.2.1.7.4 Last Verified
- 13.2.1.8 Indication
- 13.2.1.9 Study Design
- 13.2.1.10 Recruitment Status
- 13.2.1.11 Enrollment (Estimated)
- 13.2.1.12 Location Countries
- 13.2.2 Other Drugs
- 14 Hot Flashes, Key Drug Pipeline Companies
- 14.1 Astellas Pharma Inc.
- 14.1.1 Company Snapshot
- 14.1.2 Pipeline Product Portfolio
- 14.1.3 Financial Analysis
- 14.1.4 Recent News and Developments
- 14.2 Noema Pharma AG
- 14.2.1 Company Snapshot
- 14.2.2 Pipeline Product Portfolio
- 14.2.3 Financial Analysis
- 14.2.4 Recent News and Developments
- 14.3 Bayer
- 14.3.1 Company Snapshot
- 14.3.2 Pipeline Product Portfolio
- 14.3.3 Financial Analysis
- 14.3.4 Recent News and Developments
- 14.4 NeuTherapeutics
- 14.4.1 Company Snapshot
- 14.4.2 Pipeline Product Portfolio
- 14.4.3 Financial Analysis
- 14.4.4 Recent News and Developments
- 14.5 Hansoh BioMedical R&D Company
- 14.5.1 Company Snapshot
- 14.5.2 Pipeline Product Portfolio
- 14.5.3 Financial Analysis
- 14.5.4 Recent News and Developments
- 14.6 Abbvie
- 14.6.1 Company Snapshot
- 14.6.2 Pipeline Product Portfolio
- 14.6.3 Financial Analysis
- 14.6.4 Recent News and Developments
- 14.7 Novartis
- 14.7.1 Company Snapshot
- 14.7.2 Pipeline Product Portfolio
- 14.7.3 Financial Analysis
- 14.7.4 Recent News and Developments
- 14.8 Pfizer
- 14.8.1 Company Snapshot
- 14.8.2 Pipeline Product Portfolio
- 14.8.3 Financial Analysis
- 14.8.4 Recent News and Developments
- 14.9 Novo Nordisk
- 14.9.1 Company Snapshot
- 14.9.2 Pipeline Product Portfolio
- 14.9.3 Financial Analysis
- 14.9.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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