Diabetic Neuropathy - Pipeline Insight, 2025: Pioneering Disease-Modifying Therapies to Target Nerve Regeneration and Pain Relief | DelveInsight

Diabetic neuropathy, one of the most prevalent and debilitating complications of diabetes, affects nearly half of all diabetic patients over time, leading to chronic pain, sensory loss, and severe functional impairment. Despite its high global burden, current treatments primarily focus on symptomatic pain relief, with limited options available to halt or reverse the progression of nerve damage.

DelveInsight's "Diabetic Neuropathy - Pipeline Insight, 2025" reviews over 20+ emerging therapies under development, aiming to move beyond conventional analgesics to introduce disease-modifying approaches targeting the underlying mechanisms of nerve injury and metabolic dysfunction.

The pipeline is rich with candidates spanning neurotrophic factors, ion channel modulators, sodium channel blockers, aldose reductase inhibitors, TRPV1 antagonists, anti-inflammatory agents, and gene therapy platforms. These agents are designed not only to manage pain but also to promote nerve repair, reduce oxidative stress, and improve neuronal function.

Key pharmaceutical and biotech innovators in this space include Serodus, Novartis, Curacle Co., Ltd, Sonnet BioTherapeutics, Inc., Teijin America, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, ChemoCentryx, and Roche, with several drug candidates in late-phase clinical trials and combination regimens to address refractory cases.

The report provides a detailed analysis of novel delivery technologies such as oral sustained-release formulations, topical gels, injectables, and microneedle systems, along with insights into biomarker-based patient stratification, enabling a more personalized approach to treatment.

As research delves deeper into the multifactorial nature of diabetic neuropathy, encompassing inflammation, mitochondrial dysfunction, microvascular damage, and glycemic stress, the therapeutic focus is expanding toward comprehensive neuroprotection and functional restoration.

DelveInsight's report underscores a paradigm shift in diabetic neuropathy management, from temporary pain control to long-term nerve regeneration and disease modification. These advances are expected to significantly reshape the treatment landscape, improve patient quality of life, and reduce the overall economic burden associated with chronic diabetic complications.

Interested in learning more about the current treatment landscape and the key drivers shaping the diabetic neuropathy pipeline? Click here: https://www.delveinsight.com/report-store/diabetic-neuropathy-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Diabetic Neuropathy Pipeline Report
• DelveInsight's diabetic neuropathy pipeline analysis depicts a strong space with 18+ active players working to develop 20+ pipeline drugs for diabetic neuropathy treatment.
• The leading diabetic neuropathy companies include Serodus, Novartis, Curacle Co., Ltd, Sonnet BioTherapeutics, Inc., Teijin America, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, ChemoCentryx, Roche, Cyclerion Therapeutics, Inversago Pharma Inc, Sunshine Lake Pharma Co., Ltd., Goldfinch Bio, Cosette Pharmaceuticals, Boehringer Ingelheim, Chinook Therapeutics, and others are evaluating their lead assets to improve the diabetic neuropathy treatment landscape.
• Key diabetic neuropathy pipeline therapies in various stages of development include SER 150, LMB-763, CU01, SON 080, TMX-049, SPH3127, CCX140-B, Pirfenidone, Praliciguat, INV 202, HEC73077, GFB-887, Bremelanotide, Avenciguat, Atrasentan, and others.
• In March 2025, Karolinska Development AB (Nasdaq Stockholm: KDEV) announced that portfolio company PharmNovo received positive feedback regarding its most advanced drug candidate, PN6047, in a pre-IND meeting with the FDA. The meeting aimed to provide guidance on the design of the company's planned Phase IIa clinical trial for the treatment of peripheral neuropathy and allodynia.
• In January 2024, Neuralace Medical, Inc. announced FDA clearance of Axon Therapy (mPNS), the first non-invasive magnetic peripheral nerve stimulation treatment for chronic Painful Diabetic Neuropathy, offering new hope for patients.

Request a sample and discover the recent breakthroughs happening in the diabetic neuropathy pipeline landscape at https://www.delveinsight.com/report-store/diabetic-neuropathy-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Diabetic Neuropathy Overview
Diabetic neuropathy is a common and serious complication of diabetes, affecting nearly half of all diabetic patients during their lifetime. It refers to a group of nerve disorders caused by sustained high blood sugar levels that damage nerves throughout the body. The most prevalent form is peripheral neuropathy, which typically affects the feet and legs first, leading to symptoms such as pain, burning, tingling, and numbness. Other types include autonomic neuropathy, proximal neuropathy, and focal neuropathies, each impacting different organ systems or regions. The progression of diabetic neuropathy not only impairs quality of life but also increases the risk of foot ulcers, infections, and amputations.

Managing diabetic neuropathy involves tight glycemic control, lifestyle interventions, and symptom-specific treatments. Conventional therapies focus primarily on pain relief through medications like antidepressants, anticonvulsants, and opioids, though these often provide limited benefit and come with side effects. As understanding of the condition deepens, newer treatment approaches aim to address the underlying nerve damage through neuroprotective agents, anti-inflammatory drugs, and regenerative therapies. Despite growing awareness, there remains a significant unmet need for disease-modifying treatments that can halt or reverse the progression of nerve damage and restore function, making diabetic neuropathy an important area of ongoing research and drug development.

Find out more about diabetic neuropathy medication at https://www.delveinsight.com/report-store/diabetic-neuropathy-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Diabetic Neuropathy Treatment Analysis: Drug Profile
Suzetrigine: Vertex Pharmaceuticals Incorporated
Suzetrigine (formerly known as VX-548) is an investigational, orally administered small molecule developed by Vertex Pharmaceuticals. It selectively inhibits NaV1.8, a voltage-gated sodium channel implicated in pain signaling within the peripheral nervous system. NaV1.8 is a genetically validated target for pain treatment, and suzetrigine has shown a favorable benefit-risk profile across multiple clinical studies. Notably, the drug demonstrated positive efficacy and tolerability in patients suffering from painful diabetic peripheral neuropathy (DPN), a common and debilitating form of peripheral neuropathic pain. Vertex's approach is to develop a new class of non-opioid pain therapies that avoid the limitations of existing treatments, such as addiction and central nervous system side effects. Suzetrigine is currently in Phase III clinical development for the treatment of diabetic neuropathy.

NRD.E1: Novaremed
NRD.E1 (also known as NRD135S.E1) is a novel, orally bioavailable small molecule developed by Novaremed, specifically targeting painful diabetic peripheral neuropathy (PDPN). Unlike conventional pain medications, NRD.E1 acts through a unique mechanism of action that does not involve interaction with opioid, serotonin, GABA, NMDA, cannabin0id receptors, or with sodium/calcium channels and kinases. Instead, it functions by decreasing phosphorylation of Y-507 on Lyn kinase, a process implicated in the upregulation of P2X4 purinergic receptors, key players in central pain processing. NRD.E1 has shown efficacy in multiple preclinical neuropathic pain models and demonstrated an excellent tolerability profile in long-term toxicology studies in both rats and dogs. In December 2020, the FDA granted Fast Track Designation to NRD.E1 for PDPN. The drug is currently in Phase II clinical development for diabetic neuropathy.

Learn more about the novel and emerging diabetic neuropathy pipeline therapies at https://www.delveinsight.com/report-store/diabetic-neuropathy-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Diabetic Neuropathy Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Diabetic Neuropathy Pipeline Report
• Coverage: Global
• Key Diabetic Neuropathy Companies: Serodus, Novartis, Curacle Co., Ltd, Sonnet BioTherapeutics, Inc., Teijin America, Inc., Shanghai Pharmaceuticals Holding Co., Ltd, ChemoCentryx, Roche, Cyclerion Therapeutics, Inversago Pharma Inc, Sunshine Lake Pharma Co., Ltd., Goldfinch Bio, Cosette Pharmaceuticals, Boehringer Ingelheim, Chinook Therapeutics, and others.
• Key Diabetic Neuropathy Pipeline Therapies: SER 150, LMB-763, CU01, SON 080, TMX-049, SPH3127, CCX140-B, Pirfenidone, Praliciguat, INV 202, HEC73077, GFB-887, Bremelanotide, Avenciguat, Atrasentan, and others.

To dive deep into rich insights for drugs used for diabetic neuropathy treatment, visit: https://www.delveinsight.com/report-store/diabetic-neuropathy-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Diabetic Neuropathy Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Diabetic Neuropathy Pipeline Therapeutics
6. Diabetic Neuropathy Pipeline: Late-Stage Products (Phase III)
7. Diabetic Neuropathy Pipeline: Mid-Stage Products (Phase II)
8. Diabetic Neuropathy Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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jvimal@delveinsight.com
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Healthcare Consulting
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This release was published on openPR.