Diabetic Peripheral Neuropathy- Pipeline Insight, 2024

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

Diabetic Peripheral Neuropathy: Understanding

Diabetic Peripheral Neuropathy: Overview

Diabetic Peripheral Neuropathy (DPN) is a common complication of diabetes mellitus, affecting up to half of diabetic patients. It results from nerve damage caused by prolonged exposure to high blood sugar levels. DPN typically affects the peripheral nerves, particularly those in the legs and feet, leading to various sensory, motor, and autonomic disturbances.

Signs and symptoms of DPN vary depending on the nerves affected but commonly include tingling, numbness, burning pain, and weakness in the extremities. Patients may also experience sensitivity to touch, muscle cramps, and balance problems. As the condition progresses, it can lead to serious complications such as foot ulcers, infections, and even amputations if left untreated.

Diabetic Peripheral Neuropathy is a serious diabetes complication that may affect as many as 50% of people with diabetes. But one can often prevent Diabetic Peripheral Neuropathy or slow its progress with consistent blood sugar management and a healthy lifestyle. The primary cause of DPN is prolonged hyperglycemia, which damages the blood vessels that supply oxygen and nutrients to the nerves. Additionally, metabolic factors such as oxidative stress, inflammation, and the formation of advanced glycation end-products contribute to nerve damage. Genetic predisposition and lifestyle factors like smoking and alcohol consumption can also increase the risk of developing DPN.

The pathophysiology of DPN involves multiple mechanisms, including microvascular damage, impaired nerve metabolism, and altered ion channel function. These changes disrupt nerve conduction and lead to demyelination and axonal degeneration. Over time, nerve fibers become less able to transmit signals, resulting in the characteristic symptoms of DPN.

Diagnosis of DPN involves a thorough medical history, physical examination, and various tests such as nerve conduction studies and quantitative sensory testing. Management focuses on controlling blood sugar levels through lifestyle modifications, medications, and insulin therapy. Symptomatic relief can be achieved with pain medications, antidepressants, anticonvulsants, and topical agents. Additionally, physical therapy, occupational therapy, and regular foot care are essential components of DPN management to prevent complications and improve quality of life.

"Diabetic Peripheral Neuropathy- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic Peripheral Neuropathy pipeline landscape is provided which includes the disease overview and Diabetic Peripheral Neuropathy treatment guidelines.

The assessment part of the report embraces, in depth Diabetic Peripheral Neuropathy 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, Diabetic Peripheral Neuropathy 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 Diabetic Peripheral Neuropathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Peripheral Neuropathy.

Diabetic Peripheral Neuropathy Emerging Drugs Chapters

This segment of the Diabetic Peripheral Neuropathy 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.

Diabetic Peripheral Neuropathy Emerging Drugs

VM202: Helixmith Co., Ltd.

VM202 (Engensis) is an innovative gene therapy drug that provides fundamental treatment through tissue regeneration. Engensis it is non-viral plasmid DNA product, and is designed to express recombinant HGF protein in nerve and Schwann cells to promote nerve system regeneration and induce the formation of microvascular blood vessels. Engensis (VM202) has the potential to reverse the underlying cause of neuropathy through an angio-neurorestorative effect, not simply managing the pain. US FDA granted RMAT (Regenerative Medicine Advanced Therapy) designation to VM202-DPN in 2018.

This is first time in Korea, and the first and the only RMAT designation worldwide in pain area. Engensis is the first RMAT designated therapy in US of common diseases with over millions of patients. Engensis has been attracting huge attention in Painful DPN because of its big market size. Currently, the drug is in Phase III stage of its development for the treatment of Diabetic peripheral neuropathy.

WST-057: WinSanTor, Inc.

WST-057 is a novel investigational drug candidate that has been in development for over ten years. THE aim of the company is to develop the first disease-modifying treatment for peripheral neuropathy that has the potential to prevent and reverse the nerve damage and the symptoms associated with the disease. WST-057, showed the ability to prevent nerve damage and regrow damaged nerves. Phase I and Phase II are now complete.

Topical WST-057 was shown to be safe and tolerable when administered to diabetic peripheral neuropathy patients for up to six months in these studies, but will need to be studied in a larger population. WST-057 has received FastTrack designation. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic peripheral neuropathy.

CNTX-6016: Centrexion Therapeutics

CNTX-6016 is a novel, potent and highly selective investigational cannabinoid 2 (CB2) agonist currently in Phase 1 clinical trials. There are two distinct cannabinoid receptors, CB1 and CB2. A major factor holding back the development of drugs targeting the cannabinoid receptors relates to psychotropic adverse effects from CB1 activation in the central nervous system, or CNS. Whereas adverse CNS effects appear to relate to activation of CB1, published studies support that activation of CB2 receptors results in analgesia without the CB1 psychotropic effects.

In pre-clinical studies CNTX-6016 was shown to be 16,000-fold selective for CB2 over CB1 and conferred analgesia in multiple pre-clinical chronic pain models, with particular activity in models of neuropathic pain. CNTX-6016 is predicted to be well suited for the treatment of chronic neuropathic pain, such as diabetic and autoimmune neuropathic pain and chemotherapy induced neuropathy. Currently, the drug is in the Phase I stage of its development for the treatment of Diabetic Neuropathy Pain.

Diabetic Peripheral Neuropathy: Therapeutic Assessment

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

Major Players in Diabetic Peripheral Neuropathy

• There are approx. 15+ key companies which are developing the therapies for Diabetic Peripheral Neuropathy. The companies which have their Diabetic Peripheral Neuropathy drug candidates in the most advanced stage, i.e. phase III include, Helixmith Co., Ltd.

Phases

The 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

Diabetic Peripheral Neuropathy 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.

Diabetic Peripheral Neuropathy: Pipeline Development Activities

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

Diabetic Peripheral Neuropathy Report Insights

• Diabetic Peripheral Neuropathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Helixmith Co., Ltd.
• WinSanTor, Inc.
• Lexicon Pharmaceuticals, Inc
• Vertex Pharmaceuticals Incorporated
• Biogen
• Mitsubishi Tanabe Pharma Corporation
• Eli Lilly and Company
• Apurano Pharmaceuticals GmbH

Key Products

• VM202
• WST-057
• LX9211
• VX-548
• Cemdomespib
• MT-8554
• LY3857210
• Adezunap AP707

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