Endometriosis - Pipeline Insight, 2024

This “Endometriosis- Pipeline Insight, 2024” report provides comprehensive insights about 15+ companies and 20+ pipeline drugs in Endometriosis 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

Endometriosis: Understanding

Endometriosis: Overview

Endometriosis is a disease in which the endometrium (the tissue that lines the inside of the uterus or womb) is present outside of the uterus. Endometriosis most commonly occurs in the lower abdomen or pelvis, but it can appear anywhere in the body. It can cause severe pain in the pelvis and make it harder to get pregnant. Endometriosis can start at a person’s first menstrual period and last until menopause. With endometriosis, tissue similar to the lining of the uterus grows outside the uterus. This leads to inflammation and scar tissue forming in the pelvic region and (rarely) elsewhere in the body. The cause of endometriosis is unknown. There is no known way to prevent endometriosis. There is no cure, but its symptoms can be treated with medicines or, in some cases, surgery. Some people with endometriosis don’t have any symptoms. For those who do, a common symptom is pain in the lower part of the belly (pelvis). Pain may be most noticeable. Symptoms of endometriosis include lower abdominal pain, pain with menstrual periods, pain with sexual intercourse, and difficulty getting pregnant. On the other hand, some women with endometriosis may not have any symptoms at all. Approximately 10% of reproductive-aged women have endometriosis. However, the true prevalence is unknown since the diagnosis requires laparoscopy (a surgery where a doctor looks in the abdomen with a camera through the belly button) to visualize and biopsy endometriosis lesions.

Endometriosis is a complex disease that affects many women globally from the onset of their first period (menarche) through menopause, regardless of ethnic origin or social status. The major causes of endometriosis is result of many different factors are thought to contribute to its development. At present endometriosis is thought to arise due to: Retrograde menstruation, Cellular metaplasia is when cells change from one form to another. Cells outside the uterus change into endometrial-like cells and start to grow. Other factors may also contribute to the growth or persistence of ectopic endometrial tissue. For example, endometriosis is known to be dependent on estrogen, which increases the inflammation, growth and pain associated with the disease.

A careful history of menstrual symptoms and chronic pelvic pain provides the basis for diagnosing endometriosis. Although several screening tools and tests have been proposed and tested, none are currently validated to accurately identify or predict individuals or populations that are most likely to have the disease. Endometriosis can often present symptoms that mimic other conditions and contribute to a diagnostic delay. Ovarian endometrioma, adhesions and deep nodular forms of disease often require ultrasonography or magnetic resonance imaging (MRI) to detect. Histologic verification, usually following surgical/laparoscopic visualization, can be useful in confirming diagnosis, particularly for the most common superficial lesions. The need for histologic/laparoscopic confirmation should not prevent the commencement of empirical medical treatment.

The most conservative therapy for endometriosis is with medications. Non-steroidal anti-inflammatory medications, like ibuprofen, may help with the pain associated with endometriosis. Medications that control a woman’s hormones may also help with endometriosis pain. Surgery can diagnose endometriosis, and it can also treat endometriosis via removal (excision) or burning (fulguration) of endometriosis lesions. With surgery, removal of scar tissue can alleviate pain and relocate the ovaries and fallopian tubes to their normal position in the pelvis.

"Endometriosis- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Endometriosis pipeline landscape is provided which includes the disease overview and Endometriosis treatment guidelines. The assessment part of the report embraces, in depth Endometriosis 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, Endometriosis 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 Endometriosis R&D. The therapies under development are focused on novel approaches to treat/improve Endometriosis.

Endometriosis Emerging Drugs Chapters

This segment of the Endometriosis 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.

Endometriosis Emerging Drugs

• Linzagolix: ObsEva

Linzagolix, is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of endometriosis-associated pain. Linzagolix acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately dose-dependently reducing estrogen production by the ovaries. Through previously reported results from linzagolix it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression. In 2015, ObsEva in-licensed Linzagolix from Kissei Pharmaceutical Co., which had completed several Phase II clinical trials in Japan. Currently, the drug is in Phase III stage of its development for the treatment of endometriosis.

• HMI-115: Hope Medicine (Nanjing) Co., Ltd

HMI-115 is a first-in-class monoclonal antibody drug that Hope Medicine owns the global rights. In April 2019, Hope Medicine and Bayer AG signed an exclusive global license agreement for the development and commercialization of HMI-115, a monoclonal antibody targeting the prolactin receptor (PRLR), for multiple indications globally. Potential indications for the antibody include Endometriosis (EM), Androgenic Alopecia (AGA), and other chronic diseases. In 2021, Hope Medicine received approval from the FDA and EMA to conduct MRCT Phase II clinical trials for the treatment of endometriosis Hope Medicine has now completed patient enrollment and dosing at all clinical trial centers in the US and Europe. In November 2022, HMI-115 received clinical trial approval from the NMPA. Currently, the drug is in Phase II stage of its development for the treatment of endometriosis.

• VAL-301: ValiRx

VAL-301 is a small molecule, peptide, and new chemical entity it is developed in-house by ValiRx, under evaluation by an undisclosed Japanese Pharmaceutical Company. VAL301 peptide re-purposed towards non-cancerous cell proliferation. The mechanism of action of drug candidate is inhibition of androgen activation of SRC kinase. Currently, the drug is in preclinical stage of its development for the treatment of endometriosis.

Endometriosis: Therapeutic Assessment

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

Major Players in Endometriosis

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

Phases

This report covers around 20+ 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

Endometriosis 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
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

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

Endometriosis: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Endometriosis 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 Endometriosis drugs.

Endometriosis Report Insights

• Endometriosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Endometriosis 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 Endometriosis drugs?
• How many Endometriosis drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Endometriosis?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Endometriosis therapeutics?
• 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 Endometriosis and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• ObsEva
• Jiangsu HengRui Medicine Co., Ltd.
• Hope Medicine (Nanjing) Co., Ltd
• ValiRx
• BCI Pharma
• Mithra Pharmaceuticals
• Debiopharm
• Forendo Pharma Ltd
• TiumBio
• EpicentRx
• Flightpath Biosciences
• Antev

Key Products

• Linzagolix
• SHR7280
• HMI-115
• VAL-301
• Research programme: macrophage colony stimulating factor receptor 1 kinase inhibitors
• Drospirenone/estetrol
• Triptorelin
• FOR-6219
• Merigolix
• Nibrozetone
• FP-300
• Teverelix trifluoroacetate

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