Diabetic Neuropathy - Pipeline Insight, 2025

DelveInsight's, "Diabetic Neuropathy - Pipeline Insight, 2025" report provides comprehensive insights about 18+ companies and 20+ pipeline drugs in Diabetic 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 Neuropathy: Understanding

Diabetic Neuropathy: Overview

Diabetic peripheral neuropathy (DPN) is the most common form of peripheral neuropathy and a serious complication of diabetes, characterized by nerve damage due to prolonged hyperglycemia. It often presents with symptoms such as numbness, tingling, burning pain, and weakness, primarily in the lower limbs, and may progress to loss of protective sensation, increasing the risk of foot ulcers, infections, and even amputations. Diagnosis is primarily clinical, based on sensory testing and patient history, with advanced testing reserved for atypical cases. Management focuses on strict glucose control, patient education, proper foot care, and symptomatic pain relief to prevent severe outcomes.

Diabetic neuropathy presents with a wide range of symptoms depending on the type and nerves affected. The most common form, peripheral neuropathy, typically begins with pain, numbness, tingling, or burning sensations in the toes and feet, progressing upward, and may also involve the hands and arms. Patients may experience muscle weakness, heightened sensitivity to touch, reduced reflexes, and an increased risk of foot injuries, ulcers, or infections due to loss of protective sensation. Autonomic neuropathy affects involuntary functions, leading to gastrointestinal issues (e.g., bloating, constipation), cardiovascular symptoms like orthostatic hypotension, urinary and sexual dysfunction, and abnormal sweating. Less common forms include proximal neuropathy, causing pain and muscle weakness in the hips or thighs, and focal neuropathy, which presents as sudden, localized pain or nerve dysfunction in specific areas such as the torso or head.

The pathophysiology of diabetic peripheral neuropathy (DPN) involves complex metabolic and vascular mechanisms triggered by chronic hyperglycemia. Elevated blood glucose levels lead to insulin resistance, dyslipidemia, and oxidative stress in mitochondria and the endoplasmic reticulum, resulting in the accumulation of reactive oxygen species (ROS) and inflammation. This oxidative environment promotes macrophage infiltration into peripheral nerves, releasing cytokines and chemokines that damage nerve fibers. Additional contributing factors include the formation of advanced glycation end products (AGEs) and disruptions in key biochemical pathways such as hexosamine, protein kinase C, and the polyol pathway. Impaired neurovascular function, endothelial dysfunction, and deficient nerve repair mechanisms further exacerbate nerve degeneration.

The management of diabetic peripheral neuropathy (DPN) involves a comprehensive approach centered on prevention, symptom relief, and metabolic control. Key strategies include patient education, proper foot care, glycemic control, weight management, and dietary modifications. Conservative treatments such as physical therapy and Tai Chi can be beneficial, while pharmacologic options begin with gabapentinoids and duloxetine, progressing to antidepressants, topical agents, and, if needed, opioids or IV therapies. Interventional treatments like spinal cord stimulation or intrathecal drug delivery may be considered in refractory cases. Management of autonomic complications is symptom-specific, and supplements like omega-3 fatty acids, vitamin D, and alpha-lipoic acid may offer additional benefit.

"Diabetic Neuropathy- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic Neuropathy pipeline landscape is provided which includes the disease overview and Diabetic Neuropathy treatment guidelines. The assessment part of the report embraces, in depth Diabetic 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 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 Neuropathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Neuropathy.

Diabetic Neuropathy Emerging Drugs Chapters

This segment of the Diabetic Neuropathy report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, 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 Neuropathy Emerging Drugs

• Suzetrigine : Vertex Pharmaceuticals Incorporated

Suzetrigine (formerly VX-548) is an investigational oral, selective NaV1.8 pain signal inhibitor that is highly selective for NaV1.8 relative to other NaV channels. NaV1.8 is a voltage-gated sodium channel that plays a critical role in pain signaling in the peripheral nervous system. NaV1.8 is a genetically validated target for the treatment of pain, and suzetrigine has demonstrated a favorable benefit/risk profile in several clinical studies. Suzetrigine also demonstrated positive results and a well-tolerated profile in a clinical study in patients with pain associated with diabetic peripheral neuropathy, a type of peripheral neuropathic pain. Vertex's approach is to selectively inhibit NaV1.8 using small molecules with the objective of creating a new class of pain signal inhibitors that have the potential to provide effective relief of pain without the limitations of currently available therapies, including the addictive potential of opioids. Currently, the drug is in Phase III stage of its development for the treatment of Diabetic Neuropathy.

• NRD.E1: Novaremed

Novaremed's lead product NRD.E1 (or NRD135S.E1) is a new chemical entity, that is orally available and being developed to replace opioids for the treatment of painful diabetic peripheral neuropathy (PDPN). The mechanism of action of NRD.E1 is different to that of approved pain therapies as the investigational drug does not bind to or interact with receptors for opioids, serotonin, GABA, NMDA, cannabinoid; it does also not interact with sodium or calcium channels or kinases and a large number of additional pain-related targets. NRD.E1 decreases phosphorylation of Y-507 of Lyn kinase, which has been shown to be involved in upregulation of P2X4, the purinergic receptor, critical for pain processing in the central nervous system. NRD.E1 has shown efficacy in multiple preclinical models for neuropathic pain (Chung and Streptozotocine). In addition, NRD.E1 has demonstrated a very good tolerability profile in the 13-week toxicology studies both in rats and dogs. In December 2020, the US Food and Drug Administration (FDA) granted Fast Track Designation to NRD.E1 for the treatment of PDPN. Currently, the drug is in Phase II stage of its development for the treatment of Diabetic Neuropathy.

• TRV045: Trevena, Inc.

Trevena is currently developing a novel, selective sphingosine-1-phosphate subtype 1 receptor (S1P1R) modulator, TRV045, as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. S1P receptors are located throughout the body, including the central nervous system, where they are believed to play a role in modulating neurotransmission and membrane excitability. Trevena's discovery efforts have identified a family of compounds that are highly selective for the S1P1R. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. Unlike existing S1PR modulators, TRV045 did not cause lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. Currently, the drug is in Phase I stage of its development for the treatment of Diabetic Neuropathy.

Diabetic Neuropathy: Therapeutic Assessment

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

• Major Players in Diabetic Neuropathy
• There are approx. 18+ key companies which are developing the therapies for Diabetic Neuropathy. The companies which have their Diabetic Neuropathy drug candidates in the most advanced stage, i.e. Phase III include, Vertex Pharmaceuticals Incorporated.
• Phases

DelveInsight's 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 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 Neuropathy: Pipeline Development Activities

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

Diabetic Neuropathy Report Insights

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

Diabetic 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 Neuropathy drugs?
• How many Diabetic 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 Neuropathy?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Diabetic 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 Neuropathy and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Vertex Pharmaceuticals Incorporated
• Novaremed
• Trevena, Inc.
• WinSanTor, Inc
• Rigshospitalet, Denmark
• Tris Pharma, Inc.
• Novo Nordisk A/S
• JMackem Co., Ltd
• Apurano Pharmaceuticals GmbH
• Glenmark Pharmaceuticals

Key Products

• Suzetrigine
• NRD.E1
• TRV045
• WST-057
• Incobotulinumtoxin-A
• Cebranopadol
• CagriSema
• AJH-2947
• Adezunap
• GRC 17536