Postmenopausal osteoporosis - Pipeline Insight, 2024

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

Postmenopausal osteoporosis Understanding

Postmenopausal osteoporosis: Overview

Postmenopausal osteoporosis is linked with the deficiency of estrogen that occurs with the cessation of the function of the ovaries as age progresses. The function of estrogen in the bone remodeling process is very well understood after years of research; estrogen plays a part in both the formation of bone as well as the prevention of the resorption of bone. A diagnosis can be made by dual-energy X-ray absorptiometry (DEXA). It is the gold standard and can spot low bone density at particular sites. The treatment options are selected according to the severity and rate of progression and factors pertaining to each patient. The symptoms of postmenopausal osteoporosis usually aren't obvious. The condition often develops without noticeable symptoms until a fracture occurs. Common symptoms and signs of postmenopausal osteoporosis may include: Bone Fractures: Fragility fractures are a common outcome of osteoporosis. These fractures can occur with minimal or no trauma, such as a fall from standing height, and often affect the wrist, hip, and spine, Back Pain: Compression fractures in the spine (vertebral fractures) can lead to back pain, which may be mild or severe. These fractures can result in a stooped posture (kyphosis) and a decrease in height, Loss of Height: As vertebral fractures accumulate, individuals with postmenopausal osteoporosis may notice a gradual loss of height and stooped posture: Vertebral fractures can lead to a curvature of the spine, causing a stooped or hunched appearance. The diagnosis of postmenopausal osteoporosis typically involves a combination of clinical evaluation, risk assessment, and bone density testing. In clinical assessment the healthcare providers will assess an individual's medical history, risk factors, and perform a physical examination to identify signs of bone loss or fractures followed by an assessment of risk factors, such as family history, personal history of fractures, body mass index (BMI), and lifestyle factors, helps determine the likelihood of condition. Osteoporosis is an incurable chronic condition, like heart disease, diabetes, or hypertension. In postmenopausal women at high risk of fractures, initial treatment is recommend with bisphosphonates (alendronate, risedronate, zoledronic acid, and ibandronate) or denosumab as an alternative initial treatment, to reduce fracture risk. In postmenopausal women with osteoporosis at very high risk of fracture, such as those with severe or multiple vertebral fractures, Physicians recommend teriparatide treatment for up to 2 years for the reduction of vertebral and nonvertebral fractures. Preventive no pharmacological treatment includes adequate dietary intakes of key bone nutrients such as calcium, vitamin D and protein contribute to bone health and reduce thereby the risk of osteoporosis and of fracture later in life. Dietary sources of calcium are the preferred option and calcium supplementation should only be targeted to those who do not get sufficient calcium from their diet and who are at high risk for osteoporosis.

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

Postmenopausal osteoporosis Emerging Drugs Chapters

This segment of the Postmenopausal osteoporosis 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.

Postmenopausal osteoporosis Emerging Drugs

HLX14: Shanghai Henlius Biotech, Inc.HLX14 is a recombinant anti-RANKL human monoclonal antibody injection. It is denosumab biosimilar potentially indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The drug prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Currently, it is in Phase III stage of clinical trial evaluation to treat Postmenopausal osteoporosis.

CMAB807: Mabpharm LimitedCMAB807 is a Denosumab, a human IgG2 monoclonal antibody with affinity and specificity for human RANKL (receptor activator of nuclear factor kappa-B ligand), which is a transmembrane or soluble protein essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. CMAB807 prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts and their precursors. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function, and survival, thereby decreasing bone resorption and increasing bone mass and strength in both cortical and trabecular bone. Increased osteoclast activity, stimulated by RANKL, is a mediator of bone pathology in solid tumors with osseous metastases. Similarly, giant cell tumors of bone consist of stromal cells expressing RANKL and osteoclast-like giant cells expressing RANK receptor, and signaling through the RANK receptor contributes to osteolysis and tumor growth. CMAB807 prevents RANKL from activating its receptor, RANK, on the surface of osteoclasts, their precursors, and osteoclast-like giant cells. CMAB807 is currently undergoing phase III clinical trial.

EBP05: Entera Bio Ltd.EBP05 or EB613 is the first and most advanced oral, daily tablet (6mm diameter) formulation teriparatide, consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection. It acts by targeting parathyroid hormone receptor. EB613 is positioned as the first potential drug candidate that could provide a patient friendly, once daily, oral, bone building (anabolic) treatment for osteoporosis patients.

SHR-1222: Jiangsu Hengrui PharmaceuticalsSHR-1222 is a novel humanized monoclonal antibody targeting sclerostin that was developed for the treatment of osteoporosis. Preclinical studies have demonstrated that SHR-1222 exhibits high affinity for human sclerostin. Moreover, the first-in-human clinical trial (NCT03870100) indicated that single doses of SHR-1222 ranging 50-400 mg were generally well tolerated and promoted bone formation, inhibited bone resorption, and increased BMD in healthy men and postmenopausal women with low bone mass. Currently the drug is being evaluated in Phase II for the treatment of postmenopausal women with osteoporosis.

Postmenopausal osteoporosis: Therapeutic Assessment

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

Major Players in Postmenopausal osteoporosis

There are approx. 20+ key companies which are developing the therapies for Postmenopausal osteoporosis. The companies which have their Postmenopausal osteoporosis drug candidates in the most advanced stage, i.e. phase III include, Shanghai Henlius Biotech, Inc.

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

Postmenopausal osteoporosis 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
• Parenteral
• intravenous
• Subcutaneous
• Topical.

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Product Type

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

Postmenopausal osteoporosis: Pipeline Development Activities

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

Postmenopausal osteoporosis Report Insights

• Postmenopausal osteoporosis Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Shanghai Henlius Biotech, Inc.
• Mabpharm Limited
• Alvotech
• Samsung Bioepis Co., Ltd.
• Biocon Biologics
• Entera Bio Ltd.
• Genor Biopharma Co. Ltd
• Addpharma

Key Products

• HLX14
• CMAB807
• AVT03
• SB16
• Bmab 1000
• EBP05
• GB223
• AD-102

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