Hot Flashes - Pipeline Insight, 2024

This “Hot Flashes - Pipeline Insight, 2024,” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in Hot Flashes pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Hot Flashes Understanding

Hot Flashes: Overview

Hot flashes (HFs) are a rapid and exaggerated heat dissipation response, consisting of profuse sweating, peripheral vasodilation, and feelings of intense, internal heat. They are triggered by small elevations in core body temperature (Tc) acting within a greatly reduced thermoneutral zone, i.e., the Tc region between the upper (sweating) and lower (shivering) thresholds.

Hot flashes (HFs) are the most common symptom of the climacteric and are reported as feelings of intense warmth along with sweating, flushing, and chills. More than 80% of women experience hot flashes (HFs) during menopause. Defined by transient sensations of heat, sweating, flushing, anxiety, and chills lasting for 1-5 min, HFs can cause considerable distress especially when severe and frequent.

Among various factors reported to be associated with increase in incidence of HFs, a consistent association has been found only with obesity, African descent, lower socioeconomic status, presence of premenstrual syndrome, sedentary lifestyle, and smoking. HFs are characterized by excessive vasodilatation of peripheral vasculature to lose heat in setting of abnormal hypothalamic thermoneutral zone. While normal women initiate mechanisms of heat loss, once core body temperature increases by 0.4°C, women with HFs initiate vasodilatory response with a much smaller increase in core body temperature. It is peripheral vasodilatory response that results in profuse sweating and sensation of intense heat.

Hot Flashes - Pipeline Insight, 2024 report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hot Flashes pipeline landscape is provided which includes the disease overview and Hot Flashes treatment guidelines. The assessment part of the report embraces, in depth Hot Flashes commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

The companies and academics are working to assess challenges and seek opportunities that could influence in Hot Flashes R&D. The therapies under development are focused on novel approaches to treat/improve in Hot Flashes.

• In April, Fervent Pharmaceuticals has initiated a virtual at home Phase II clinical trial of its new product to treat the symptoms of moderate to severe hot flashes, night sweats and night-time awakenings due to hot flashes in women. Named M2S Hot Flash Study, the trial will analyse the peri- and post-menopausal therapy to treat hot flashes and night sweats.
• In January 2020, Veru Inc, developing novel medicines for the management of prostate cancer, today announced positive top line data interim results from its Phase 2 clinical study of Zuclomiphene citrate, a nonsteroidal oral estrogen receptor agonist, for the treatment of androgen deprivation hormone therapy (ADT) induced hot flashes, also known as vasomotor symptoms, in men who have advanced prostate cancer. Zuclomiphene appears to be well tolerated as there have been no reports of drug related serious adverse events nor drug related severe adverse events and no observations of adverse events of special interest, such as breast enlargement or pain, or venothromboembolic events (blood clots in legs or lungs, or stroke) in the safety database for the Phase 2 clinical study.

This segment of the Hot Flashes report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Hot Flashes Emerging Drugs

Fezolinetant: Astellas Pharma Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established. If approved by regulatory authorities, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of VMS associated withmenopause.

Elinzanetant: Bayer Elinzanetant is a first-in-class, non-hormonal, orally administered, dual neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms during menopause. Elinzanetant addresses vasomotor symptoms by modulating a group of oestrogen sensitive neurons in the hypothalamus in the brain (the KNDy neurons), that due to the absence of oestrogen, become hyperactive in menopausal women and consequently disrupt body heat control mechanisms resulting in the debilitating vasomotor symptoms of hotflashes.

Fezolinetant: Ogeda Fezolinetant (ESN364) is a proprietary, oral, small-molecule, discovered and developed by Ogeda for the purpose of the treatment of women’s health disorders. Fezolinetant’s mechanism of action to mimic the neuronal effects of estrogen to control body temperature supports the use of fezolinetant to directly and safely address the basis for hot flashes in menopausal women. In addition, fezolinetant addresses the cause of PCOS by selectively lowering luteinizing hormone (LH) without affecting follicle-stimulating hormone (FSH) in order to restore the correct LH-to-FSH ratio and permit the restoration of menstrual cycle regularity and fertility. Fezolinetant is also superior to the existing, marketed gonadotropin-releasing hormone (Gn RH) ligands as it reduces levels of the ovarian hormones estrogen and progesterone in a non-castrating manner as required for the safe, effective treatment of uterine fibroidsandendometriosis.

Zuclomiphene citrate: Veru Inc Zuclomiphene citrate is a novel, proprietary, oral, nonsteroidal, estrogen receptor agonist. Today the Company announced that a Phase 2 clinical trial of Zuclomiphene citrate demonstrated a statistically significant reduction in the frequency of moderate to severe hot flashes in men with advanced prostate cancer on ADTtherapy.

Hot Flashes: Therapeutic Assessment

This segment of the report provides insights about the different Hot Flashes drugs segregated based on following parameters that define the scope of the report, such as:

Major Players in Hot Flashes

There are approx. 15+ key companies which are developing the therapies for Hot Flashes. The companies which have their Hot Flashes drug candidates in the most advanced stage, i.e. Phase III include Veru Inc.

Phases

This report covers around 15+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

Route of Administration

Hot Flashes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous

Molecule Type

Products have been categorized under various Molecule types such as

• Small molecule
• Thiadiazoles
• Recombinant proteins

Product Type
Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Hot Flashes: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hot Flashes therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Hot Flashes drugs.

Hot Flashes Report Insights

• Hot Flashes Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hot Flashes Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Hot Flashes drugs?
• How many Hot Flashes drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hot Flashes?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hot Flashes?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Hot Flashes and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Veru Healthcare
• Fervent Pharmaceuticals
• Ogeda
• Bayer
• Lundbeck A/S
• Therapeutics MD
• MenoGeniX
• Mitsubishi Tanabe Pharma
• QUE Oncology
• Pherin Pharmaceuticals

Key Products

• Zuclomifene
• FP-101
• Fezolinetant
• Elinzanetant
• SJX 653
• TX-001HR
• MNGX-100
• MT-8554
• Q 122
• Salubrin HF

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