Pilot/Phase IIa Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes
The primary purpose of this study was to evaluate the effect of ESN364 on the severity and frequency of hot flashes in early postmenopausal women suffering from hot flashes, in terms of changes in weekly Hot Flash Score from baseline to Week 12. This study also evaluated the effect of ESN364 on the severity and frequency of hot flashes at additional timepoints; hot flash interference on daily life, in terms of changes from baseline over time in Hot Flash Related Daily Interference Scale (HFRDIS); the effect of ESN364 on climacteric symptoms, in terms of changes from baseline over time in Leeds Sleep Evaluation Questionnaire (LSEQ), Greene Climacteric Scale (GCS), and Sheehan Disability Scale (SDS); pharmacodynamic (PD) effect; and safety and tolerability.
A Phase IIa, Double-Blind, Placebo-Controlled, Study of ESN364 Administered for 12 Weeks to Evaluate Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Women Presenting With Uterine Fibroids
The menopause market is anticipated to surge significantly in the coming years due to the emergence of new products in the pipeline. In addition, persistently rising cases of menopause in the forecast period will help increase the menopause treatment market.
LAS VEGAS, Sept. 12, 2023 /PRNewswire/ -- DelveInsight's
Menopause Market Insights report includes a comprehensive understanding of current treatment practices, menopause emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan].
Key Takeaways from the Menopause Market Report
As per DelveInsight analysis, the menopause market size in the 7MM was approximately
USD 11 billion in 2022.
According to the assessment done by DelveInsight, the total number of women in menopause in the 7MM comprised approximately
100 million cases in 2022 and are projected to increase during the forecast period.
Leading menopause companies such as
Viramal Limited, Simbec Research, Estetra, Mithra Pharmaceuticals, Bayer, Nerre Therapeutics Ltd., Mitsubishi Tanabe Pharma America Inc., MenoGeniX, QUE Oncology, Fervent Pharmaceuticals, and others are developing novel menopause drugs that can be available in the menopause market in the coming years.
The promising menopause therapies in the pipeline include
Transdermal Estradiol Cream (VML-0203), DONESTA (E4, Estetrol), Elinzanetant (BAY3427080), MT-8554 (Elismetrep), MNGX-100 (Filgrastim/G-CSF), Q-122 (MSX-122), FP-101, and others.
Discover which therapies are expected to grab the major menopause market share @
Menopause Market Report
Menopause is a natural biological process that marks the end of a woman's reproductive years. It usually occurs between the ages of 45 and 55, with an average age of around 51. This phase is characterized by a decline in the production of hormones like estrogen and progesterone, leading to the cessation of menstruation and fertility. The primary cause of menopause is the aging of the ovaries, which results in a reduced number of eggs and a decline in hormone production. However, certain medical procedures like hysterectomy, chemotherapy, and radiation therapy can induce menopause prematurely.
Menopause brings about a range of symptoms that can vary widely from woman to woman. Common menopause symptoms include hot flashes, night sweats, mood swings, irritability, fatigue, vaginal dryness, and sleep disturbances. These symptoms occur due to the hormonal fluctuations that take place during the transition to menopause. Diagnosing menopause is often based on a woman's age, medical history, and symptoms. A key factor is the absence of menstruation for 12 consecutive months, signaling the end of the reproductive period. In some cases, healthcare providers may recommend blood tests to measure hormone levels, such as follicle-stimulating hormone (FSH) and estrogen, to confirm the onset of menopause.
Menopause Epidemiology Segmentation
DelveInsight estimates that there were approximately
million total women in menopause in the 7MM in 2022.
For the age-specific analysis, the number of cases of menopause were distributed across various age groups, such as <40 years, 40–50 years, 51–60 years, and 61–65 years, in the 7MM. As per the analysis, the highest number of cases were estimated in the age-group 51-60 years and the lowest in <40 years with
64 million and 3.4 million cases, respectively in 2022.
The menopause market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM segmented into:
Total Number of Women in Menopause
Stage-Specific Distribution of Women in Menopause
Age-Specific Distribution of Women in Menopause
Number of Women in Menopause with Vasomotor Symptoms
Number of Women in Menopause with Moderate-to-Severe Vasomotor Symptoms
Menopause Treatment Market
The North American Menopause Society (NAMS) suggests waiting until the hot flashes become troublesome to the woman before seeking treatment. The intensity of symptoms, an assessment of treatment-related risks, and the woman's views towards menopause and drugs should all be considered before starting treatment.
Duavee (bazedoxifene acetate/conjugated estrogens) is the first and only medicine that combines CE with an estrogen agonist/antagonist, commonly known as a selective estrogen receptor modulator (SERM), for the treatment of menopausal VMS. Duavee employs bazedoxifene rather than progestin to help protect the uterine lining from hyperplasia that may occur as a result of estrogen-only treatment.
Many women use non-prescription therapies to address disorders such as hot flashes, such as
isoflavones, black cohosh, and progesterone-containing hormone lotions. The clinical evidence for the efficacy and long-term safety of these therapies is insufficient. Furthermore, most over-the-counter medications for hot flashes are classified as nutritional supplements and, as such, are not regulated by the US Food and Drug Administration. Prescription medications for various purposes that have demonstrated some benefit in alleviating hot flashes are available for women who have hot flashes but cannot undergo hormone therapy. Certain prescription antidepressants may reduce hot flashes in women, including those with a history of breast cancer. Others include
gabapentin, clonidine, and methyldopa. The NAMS recommends that women who need relief from mild menopause-related hot flashes first consider lifestyle changes such as manipulating the environment to keep the core body temperature cool, getting regular exercise, quitting smoking, and using relaxation techniques such as paced respiration.
To know more about menopause treatment, visit @
Menopause Treatment Drugs
Key Menopause Therapies and Companies
Transdermal Estradiol Cream (VML-0203): Viramal Limited/Simbec Research
DONESTA (E4, Estetrol): Estetra/Mithra Pharmaceuticals
Elinzanetant (BAY3427080): Bayer|Nerre Therapeutics Ltd.
MT-8554 (Elismetrep): Mitsubishi Tanabe Pharma America Inc.
MNGX-100 (Filgrastim/G-CSF): MenoGeniX
Q-122 (MSX-122): QUE Oncology
FP-101: Fervent Pharmaceuticals
Learn more about the FDA-approved drugs for menopause @
Drugs for Menopause Treatment
Menopause Market Dynamics
The menopause market dynamics are undergoing significant shifts as societal awareness of women's health and well-being continues to grow. With an
aging population and increasing focus on women's empowerment, there's a heightened demand for innovative products and services addressing the physical and emotional challenges associated with menopause. This has spurred a
surge in research and development, leading to the creation of a diverse range of
hormone replacement therapies, herbal supplements, lifestyle apps, and personalized health plans.
As more women seek effective and holistic solutions, companies are embracing a more
consumer-centric approach, tailoring their offerings to individual needs and preferences. Additionally, discussions around menopause are becoming
less taboo, allowing for open dialogue and information-sharing, further shaping the menopause market dynamics by fostering a supportive ecosystem for women navigating this life stage.
However, despite the potential for growth, this menopause market is not without its barriers.
Stringent regulatory processes for hormonal treatments and supplements, coupled with concerns about product
safety and efficacy, pose challenges for menopause market entrants. Additionally,
cultural stigmas and misinformation surrounding menopause still exist in certain societies, inhibiting open discussions and the adoption of new solutions.
Economic disparities and limited access to healthcare further compound these issues, preventing equal menopause market penetration. Overcoming these barriers requires a multi-faceted approach, involving education, regulatory reforms, and inclusive product development, to truly tap into the menopause market's potential.
Scope of the
Therapeutic Assessment: Menopause current marketed and emerging therapies
Market Dynamics: Attribute Analysis of Emerging Menopause Drugs
Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
Unmet Needs, KOL's Views, Analyst's Views, Menopause Market Access and Reimbursement
Discover more about menopause drugs in development @
Menopause Clinical Trials
Table of Contents
Hot Flashes Pipeline
Hot Flashes Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hot flashes companies, including
Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, Pherin Pharmaceuticals, among others.
Hot Flashes Market
Market Insight, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key hot flashes companies, including
Veru Healthcare, Fervent Pharmaceuticals, Ogeda, Bayer, Lundbeck A/S, TherapeuticsMD, MenoGeniX, Mitsubishi Tanabe Pharma, QUE Oncology, among others.
Menopause Global Market
Menopause Market Insights, Competitive Landscape, and Market Forecast – 2028 report deliver an in-depth understanding of the disease, market trends, market drivers, market barriers, and key menopause companies including
ISIDEN, Novapharm, Arkopharma, Pileje, Thermamex, ÉLERTÉ Laboratories, Serelys Pharma, Besins Healthcare, Bayer, ITALFARMACO S.p.A, Pfizer Inc, Mylan NV, Teva Pharmaceuticals, TherapeuticsMD, Inc, Novo Nordisk, Novartis, Millicent Pharma, PADAGIS LLC, Vertical Pharmaceuticals LLC, Amgen, among others.
Vasomotor Symptoms of Menopause Pipeline
Vasomotor Symptoms of Menopause Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key vasomotor symptoms of menopause companies, including
Mithra Pharmaceuticals, Acer Therapeutics, QUE Oncology, Bayer, Endoceutics, Astellas Pharma, Mitsubishi Tanabe Pharma, MenoGenix, among others.
DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve
SOURCE DelveInsight Business Research, LLP
Significant support from investors including the European Investment Fund
Fund to invest in first and best-in-class European life science companies in drug development and digital health
STRASSEN, Luxembourg, June 29, 2023 /PRNewswire/ -- Vesalius Biocapital, the specialist life sciences venture capital investor, announces the first close of its fourth fund, Vesalius Biocapital IV, securing over €95 million of commitments. The fund has attracted blue chip investors including the European Investment Fund (EIF). Starting immediately Vesalius Biocapital IV is to invest in first and best-in-class European life science companies in drug development and digital health. The goal is to build a well-balanced portfolio of 10-15 companies, providing capital and the Vesalius team's experience and expertise to support their development.
Now in its sixteenth year, Vesalius Biocapital has a successful track record of backing highly innovative companies and has raised over €270 million from a renowned investor base for its three previous funds. It has completed over 30 investments with lead or co-lead positions and achieved numerous exits through trade sales and IPOs. These include: Forendo, acquired by Organon; Sword Health sold to a group of private equity investors; Apitope acquired by Chinese company Worg Pharma; and Ogeda acquired by Astellas Pharma. With a well-balanced portfolio between drug development and non-drug development investments, Vesalius has a successful track-record of strong and consistent financial performance and has generated significant returns for its investors.
Commenting on the first close, Stéphane Verdood, Managing Partner at Vesalius Biocapital IV said:
"Our successful track record placed us in a strong position to attract high quality investors such as the EIF (European Investment Fund) to Vesalius Biocapital IV. Furthermore, it is fantastic validation of our investment approach and strategy that a significant number of investors in our previous funds are backing us in Vesalius Biocapital IV. This is an exciting time in healthcare; the industry is at a key inflection point between science, technology and medicine, and our investors support our strategy to invest in companies developing innovative first in class products and technologies."
Guy Geldhof, Managing Partner at Vesalius Biocapital IV, added:
"While our investment focus remains in Europe where we continue to see many high-quality life science companies, we will continue to help our portfolio companies to expand to the US to enable them to achieve optimum valuations and to access the US capital markets. We will also be looking to invest in North American companies that are looking to Europe for development, expansion or access to innovation."
Marjut Falkstedt, Chief Executive Officer at the European Investment Fund, commented:
"The development of new therapies and digital health solutions are revolutionising the healthcare sector, but these innovations need targeted, dedicated investment. The EIF is glad to partner with Vesalius for its fourth fund, building on a strong track record in the sector, which also aims to channel investment towards underserved areas in the innovation landscape, particularly in southern Europe."
Vesalius Biocapital IV is targeting €150M and will accept new investors on a "rolling closing" basis until the final closing in 2024.
ABOUT VESALIUS BIOCAPITAL
Vesalius Biocapital (Vesalius), the specialist life sciences venture capital investor, has supported companies active in human health through venture capital funds since 2007. In the sixteen years since inception, the three predecessor funds have raised over €270 million.
The investment portfolio is well balanced between drug development and non-drug development investments and committed to providing capital to science-backed innovation and ambitious entrepreneurs, with a strong focus on exit within five years.
Vesalius Biocapital IV, launched in June 2023, targets first and best-in-class European life science companies in drug development and digital health. The fund secured over €95 million of commitments in a first closing in June 2023, with a target size of minimum €150 million.
The specialist team consists of seasoned life science professionals with healthcare industry, corporate finance and strategy development experience, supporting companies through their growth cycle. The team is based in Europe to explore investment opportunities and valuation potential for the portfolio. Managing Partners include Guy Geldhof, Dr Jean-Christophe Renondin and Stéphane Verdood. Partners include Dr Fabienne Roussel and Olivier Houben. The investment team is complemented by Dr David Cristina and Qasim Zawawi who joined as principals and Dr Hayley French and Dr Stephane Heymans who joined as venture partners.
SOURCE Vesalius Biocapital
On Friday, the U.S FDA
Astellas Pharma's once daily pill for the treatment of menopause symptoms.
The drug, branded Veozah, is a neurokinin 3 (NK3) receptor antagonist that offers the first nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.
The approval was not without obstacles, coming later than initially expected for Astellas. The Tokyo-based drugmaker's NDA was accepted back in
. The application hinged on three phase 3 trials which enrolled 2,800 women from across the U.S., Canada and Europe. Astellas cashed in its valuable Priority Review voucher to speed up the drug's review, and the drug was assigned a PDUFA date in February. Then, just before its decision date, the FDA
its decision to May 22, 2023.
Astellas first got its hands on fezolinetantin
, when it completed theacquisitionofOgeda for $500 million upfront.Now apotential blockbuster, the treatment is projected to reach an annual total of$1.21 billion in U.S. sales by 2032, according toGlobalData's Expiry Model.