Diabetic Peripheral Neuropathy- Pipeline Insight, 2025

This “Diabetic Peripheral Neuropathy- Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ 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.

Diabetic Peripheral Neuropathy: Understanding

Diabetic Peripheral Neuropathy: Overview

Diabetic peripheral neuropathy (DPN) is a common and debilitating complication of diabetes, affecting up to 50% of patients with both type 1 and type 2 diabetes. DPN primarily results from prolonged hyperglycemia, which causes progressive nerve damage, starting with the distal sensory and autonomic fibers and advancing proximally. This gradual degeneration of the peripheral nervous system results in a wide range of sensory, motor, and autonomic dysfunctions. Clinically, patients often present with symptoms such as numbness, tingling, burning sensations, aching, or sharp, shooting pains, predominantly in the lower extremities.

Diabetic peripheral neuropathy (DPN) is a severe diabetes complication resulting from prolonged high blood sugar levels, causing nerve damage, particularly in the feet and legs. Common symptoms include:

Numbness, Tingling or 'Pins and Needles, Burning Sensation, Sharp Pain or Cramps, Extreme Sensitivity to Touch, Loss of Balance and Coordination, Muscle Weakness and Digestive and Autonomic Symptoms.

Risk factors for DPN are multifaceted and include advanced age, where aging processes naturally predispose the nervous system to degeneration. Hypertension and dyslipidemia, both common comorbidities in diabetic patients, exacerbate vascular damage and contribute to the reduced blood flow to nerves, furthering their vulnerability to injury. Peripheral vascular disease, often seen in diabetic individuals, similarly restricts adequate blood supply to nerves, leading to ischemic damage. Smoking compounds the risk of neuropathy by promoting vasoconstriction and oxidative stress, while excessive alcohol consumption can cause both direct neurotoxicity and worsen glycemic control.

The pathophysiology of DPN is largely driven by chronic hyperglycemia, which initiates a cascade of biochemical changes, leading to nerve damage. Elevated serum glucose levels result in insulin resistance and dyslipidemia, both of which contribute to significant oxidative stress within the endoplasmic reticulum and mitochondria of peripheral nerve cells. This oxidative stress occurs due to the excessive production of reactive oxygen species (ROS), which overwhelm the cell's antioxidant defense mechanisms. Diabetic peripheral neuropathy (DPN) is diagnosed through several steps, starting with a detailed clinical history and physical examination to assess symptoms and exclude other causes of neuropathy. Key diagnostic methods include neurological assessments such as nerve conduction studies, quantitative sensory testing, and skin biopsies to evaluate nerve damage. Clinical scoring systems like the Michigan Neuropathy Screening Instrument (MNSI) and Neuropathy Disability Score (NDS) help gauge DPN severity. Emerging tools, such as the Vibration Perception Threshold (VPT) and retinal vascular geometry analysis, offer additional ways to detect and monitor DPN.

Managing diabetic peripheral neuropathy (DPN) involves a multi-faceted approach that includes preventive measures, conservative, pharmacological, interventional, and alternative therapies. Preventive strategies focus on glucose control, foot care, and education to avoid complications. Conservative treatments like physical therapy and non-invasive techniques help improve mobility and reduce pain. Pharmacological treatments include gabapentinoids, SNRIs, and topical agents to manage neuropathic pain. Interventional therapies, such as spinal cord stimulation, are used for severe cases. Alternative therapies, including omega-3 supplements and vitamin D, may offer additional benefits in managing symptoms and improving quality of life.

'Diabetic Peripheral Neuropathy- Pipeline Insight, 2025' 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 III, II, II/III 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

Adezunap: Apurano Pharmaceuticals

Adezunap (also known as AP707) is a cannabinoid-based investigational drug developed by Apurano Pharmaceuticals. It utilizes the company's PuranoTec® bio-nanotechnology to enhance the absorption and bioavailability of THC, the active ingredient. This innovative approach overcomes the challenges of water-insoluble cannabinoids by using lipid-based nanoparticles for effective oromucosal delivery. Adezunap is being developed primarily for chronic pain management, a field with significant unmet therapeutic needs. The drug recently underwent a Phase I clinical trial (SELECT I), where it demonstrated favorable pharmacokinetics, tolerability, and safety. Healthy male participants were given a single dose of Adezunap, and despite relatively high blood levels of THC and its active metabolite, no psychotropic effects or serious adverse events were observed. Compared to existing cannabinoid drugs, Adezunap showed a higher systemic exposure, which may translate to enhanced efficacy without compromising safety. This makes it a promising candidate for conditions such as neuropathic pain and chronic pain syndromes. The drug is currently being investigated in the Phase III stage of development for the treatment of Diabetic Peripheral Neuropathy.

NRD.E1: Novaremed

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. In addition, NRD.E1 has demonstrated a very good tolerability profile in the 13-week toxicology studies both in rats and dogs. Currently, the drug is in the Phase II stage of its development for the treatment of Diabetic Peripheral Neuropathy

TRV045: Trevena

TRV045 is a novel, highly selective sphingosine-1-phosphate subtype 1 (S1P1) receptor modulator being developed as a potential treatment for acute and chronic neuropathic pain secondary to diabetic peripheral neuropathy. Through a collaboration with the National Institutes of Health, Trevena is also exploring TRV045 as a potential treatment for epilepsy. 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 S1P1 receptor. TRV045 reversed thermal hyperalgesia, a measure of neuropathic pain, in nonclinical models of diabetic peripheral neuropathy and chemotherapy-induced peripheral neuropathy. TRV045 was not associated with lymphopenia and produced no changes in blood pressure, heart rate, or respiratory function at or above pharmacologically active doses in nonclinical studies. TRV045 is an investigational product and is not yet approved by the FDA. The drug is currently in Phase I stage of its development for the treatment of Diabetic Peripheral Neuropathy.

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, Apurano Pharmaceuticals.

Phases

The report covers around 25+ 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

• Intravenous
• Subcutaneous
• Oral
• Intramuscular

Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide

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

• Apurano Pharmaceuticals
• Novaremed
• Trevena
• Helixmith
• Applied Therapeutics
• WinSanTor
• Centrexion Therapeutics
• Praetego

Key Products

• Adezunap
• NRD.E1
• TRV045
• Engensis
• AT-001
• WST-057
• CNTX-6016
• PTG-630

This product will be delivered within 1-3 business days.