+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Diabetic Peripheral Neuropathy - Pipeline Insight, 2021

  • PDF Icon

    Clinical Trials

  • 60 Pages
  • September 2021
  • Region: Global
  • DelveInsight
  • ID: 4330666
UP TO OFF until Dec 31st 2023
This “Diabetic Peripheral Neuropathy - Pipeline Insight, 2021,” report provides comprehensive insights about 20+ 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) also known Distal symmetric polyneuropathy (DSPN) is defined as the symptoms and/or signs of peripheral nerve dysfunction and nerve damage in diabetic patients after the exclusion of other causes. It is a predominantly sensory neuropathy with autonomic nervous system involvement, although there are often motor features with advancing disease. Both vascular and metabolic factors are involved in the development of DPN. Patients with the disorder typically experience the loss of nerve fibers due to impaired blood flow, resulting in impaired nerve sensitivity or pain. Patients with DPN also develop vascular deformities and hypertrophy as well as reduced oxygen tension compared with normal individuals. These effects underscore the relationship between vascular and neurostructural changes in patients with DPN. Major risk factors contributing to DSPN are smoking, obesity, hyperlipidemia, duration of diabetes, large total exposure to hyperglycemia, advanced age, elevated lipid levels, elevated blood pressure, kidney disease, cigarette smoking, overweight, increased height, and others. DPNs range from mild sensory disturbances to painful, debilitating syndromes. One classification system divides DPNs into symmetrical and asymmetrical neuropathies. Diagnosis of DSPN includes the screening, assessment, quantitative sensory testing, nerve conduction studies, novel surrogate imaging markers of DPN, biopsy for skin and nerve fiver, optical coherence tomography and others. Management and prevention of the DSPN generally includes glycemic control, lifestyle modification, pathogenetic therapies and pain management by using the various pharmaceutical intervention.

"Diabetic Peripheral Neuropathy - Pipeline Insight, 2021" report by the publisher 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

Helixmith's non-viral plasmid DNA product, Engensis, 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. A single injection of Helixmith's proprietary plasmid DNA product expresses the HGF gene at levels 30-40 times higher than conventional plasmid DNA and provides sustained gene expression in mouse models for 2 weeks, with peak protein expression at Day 7 and a gradual decrease over the next week. eyond potentially alleviating pain, Engensis is designed to target the underlying causes of neuropathy through its predicted angiogenic and neuroregenerative properties. The drug is currently being evaluated in Phase III clinical trials to treat diabetic peripheral neuropathy. The US FDA recognized the potential for Engensis to meet the unmet need for this condition in 2018 by designating it as a Regenerative Medicine Advanced Therapy (RMAT), making it the first RMAT-designated gene therapy for a prevalent disease with over one million patients.

Ricolinostat: Regenacy Pharmaceuticals

Ricolinostat (Regenacy Pharmaceuticals) is an oral, selective inhibitor of the microtubule modifying enzyme HDAC6 with the first-in-class potential. Ricolinostat restores nerve function by inhibiting HDAC6, which reestablishes the transport function of microtubules in the axon of the nerve cell. The company has initiated patient enrollment into a phase II study of ricolinostat for the treatment of painful diabetic peripheral neuropathy and is being conducted at multiple investigative centers in the United States. Results from the study are expected to be available in 2022. In prior Phase I and II clinical studies, ricolinostat has demonstrated an excellent safety and tolerability profile.

NYX-2925: Aptinyx

NYX-2925 (Aptinyx) is an oral, small-molecule modulator of the NMDA receptor, works by enhancing synaptic plasticity. It has received Fast Track designation for the treatment of neuropathic pain associated with DPN. According to the company, the therapeutic profile of NYX-2925 will be expanded into multiple other chronic pain conditions. In Phase I study, NYX-2925 was safe and well-tolerated in healthy volunteers. The company resumed the phase II study in January 2021 following suspension of enrollment due to escalation of COVID-19 pandemic. The company expects to read out data from each of these study in the first half of 2022.

LX9211: Lexicon Pharmaceuticals

LX9211 (Lexicon Pharmaceuticals) is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical data demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain. In December 2020, LX9211 received Fast Track designation from the US FDA for the development of LX9211 in diabetic peripheral neuropathic 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. 20+ 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.


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

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
  • 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

The 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 Answered

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?

This product will be delivered within 2-4 business days.

Table of Contents


Executive Summary

Diabetic Peripheral Neuropathy: Overview
  • Causes
  • Mechanism of Action
  • Signs and Symptoms
  • Diagnosis
  • Disease Management

Pipeline Therapeutics
  • Comparative Analysis

Therapeutic Assessment
  • Assessment by Product Type
  • Assessment by Stage and Product Type
  • Assessment by Route of Administration
  • Assessment by Stage and Route of Administration
  • Assessment by Molecule Type
  • Assessment by Stage and Molecule Type

Late Stage Products (Phase III)
  • Comparative Analysis

VM202: Helixmith
  • Product Description
  • Research and Development
  • Product Development Activities

Mid Stage Products (Phase II)
  • Comparative Analysis

Ricolinostat: Regenacy Pharmaceuticals
  • Product Description
  • Research and Development
  • Product Development Activities

Early stage products (Phase I)
  • Comparative Analysis

SYHA 1402: CSPC ZhongQi Pharmaceutical Technology
  • Product Description
  • Research and Development
  • Product Development Activities

Inactive Products
  • Comparative Analysis

Diabetic Peripheral Neuropathy Key Companies

Diabetic Peripheral Neuropathy Key Products

Diabetic Peripheral Neuropathy- Unmet Needs

Diabetic Peripheral Neuropathy- Market Drivers and Barriers

Diabetic Peripheral Neuropathy- Future Perspectives and Conclusion

Diabetic Peripheral Neuropathy Analyst Views

Diabetic Peripheral Neuropathy Key Companies

AppendixList of Tables
Table 1 Total Products for Diabetic Peripheral Neuropathy
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive ProductsList of Figures
Figure 1 Total Products for Diabetic Peripheral Neuropathy
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products

Companies Mentioned

A selection of companies mentioned in this report includes:

  • Helixmith
  • Haisco Pharmaceutical
  • NeuromaxBionevia
  • Regenacy Pharmaceuticals
  • Aptinyx
  • Mitsubishi Tanabe Pharma
  • Bayer
  • Celularity Incorporated
  • Lexicon Pharmaceuticals
  • Lateral Pharma
  • WinSanTor, Inc
  • Eli Lilly and Company
  • CSPC ZhongQi Pharmaceutical Technology
  • Praetego
  • Trevena
  • Pure Green
  • Applies Therapeutics
  • Novaremed
  • JanOne
  • RegeneRx Biopharmaceuticals