Diabetic Foot Ulcers Pipeline Insight

DelveInsight’s, “Diabetic Foot Ulcers - Pipeline Insight, 2022,” report provides comprehensive insights about 35+ companies and 35+ pipeline drugs in Diabetic Foot Ulcers 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 Foot Ulcers Understanding

Diabetic Foot Ulcers: Overview

Diabetic foot ulcers are a devastating component of diabetes progression and are caused by loss of glycemic control, peripheral neuropathy, peripheral vascular disease, and immunosuppression. An estimated 15% of patients with diabetes have diabetic foot ulcers. Diabetic foot ulcers are one of several serious complications of diabetes progression. Major contributing causes to diabetic foot ulcers are peripheral neuropathy, peripheral arterial disease, and immunosuppression. Up to 15% of patients with diabetes have diabetic foot ulcers, and these ulcers lead to more than 80,000 amputations per year in the United States. The lifetime risk of diabetic foot ulcers for patients with diabetes may reach up to 68 per 1,000 persons as reported by some studies. As a diabetic foot ulcer progresses, the patient's risk for amputation increases; in nearly 84% of patients who have a lower limb amputation secondary to diabetes, the amputation is preceded by a diabetic foot ulcer. Peripheral neuropathy secondary to diabetes is an etiologic factor of diabetic foot ulcers and is estimated to affect 5.5 million people in the United States. The estimated annual cost of treating peripheral neuropathy in patients with diabetes is $10.91 billion. These collective findings indicate that diabetic foot ulcers lead to serious disability, serious reduction in patient quality of life, and high financial costs for society. With increased vigilance on risk assessment, diagnosis, and management of diabetic foot ulcers, clinicians can improve patient outcomes and reduce healthcare costs. The pathophysiology of diabetic foot ulcers has neuropathic, vascular, and immune system components, which all show a base relationship with the hyperglycemic state of diabetes. Damage to motor neurons of the foot musculature may lead to an imbalance of flexors and extensors, anatomic deformities, and eventual skin ulcerations. Damage to autonomic nerves impairs sweat gland function, and the foot may develop decreased ability to moisturize skin, leading to epidermal cracks and skin breakdown. Lastly, patients may not notice foot wounds because of decreased peripheral sensation. Because the blood supply required to heal a diabetic foot ulcer is greater than that needed to maintain intact skin, chronic ulceration can develop. Patients with diabetes should be assessed for arterial insufficiency and neuropathic disease on a structured schedule based on defined risk factors. Assess the patient's temperature, respirations, heart rate, and BP in both extremities and document any abnormalities.

 

"Diabetic Foot Ulcer- Pipeline Insight, 2022" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic Foot Ulcer pipeline landscape is provided which includes the disease overview and Diabetic Foot Ulcer treatment guidelines. The assessment part of the report embraces, in depth Diabetic Foot Ulcer 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 Foot Ulcer 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 Foot Ulcer R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Foot Ulcer. 

Diabetic Foot Ulcer Emerging Drugs Chapters

This segment of the Diabetic Foot Ulcer 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 Foot Ulcer Emerging Drugs

 

Pravibismane : Microbion Corporation

Topically administered pravibismane, comprised of a suspension of pravibismane in a hydrogel formulation (named MBN-101), has the potential to provide important advantages for the treatment of DFIs, including the dual broad-spectrum antimicrobial and anti-biofilm effects of the drug and its ability to kill common antibiotic resistant species. A Phase 1b/2a clinical study of topically applied pravibismane (MBN-101) with adjunct systemic antibiotic in patients with moderate to severe Diabetic Foot Infection (DFI) has been completed. Topical pravibismane (MBN-101) was well tolerated and no Treatment Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) occurring in the study were considered related to study drug. Although the study was not designed to demonstrate statistical efficacy, a numerical trend of greater median wound size reduction and reduced amputation rate with topical pravibismane treatment was observed compared to placebo. Qualified Infectious Disease Product (QIDP) designation and Fast Track status was granted for topical pravibismane (MBN-101) by the US FDA for adjunctive treatment of moderate and severe diabetic foot ulcer infections.

 

Nemonoxacin : TaiGen Biotechnology

The novel antibiotic Taigexyn® (Nemonoxacin) is TaiGen’s first approved drug. Drug-resistant bacterial infection is a global crisis, as standard treatments are becoming less and less effective against the types of infections commonly encountered in hospital or community environments. Taigexyn® (Nemonoxacin) was acquired under license by TaiGen 2004 from Procter & Gamble Pharmaceuticals. Currently the drug is in Phase II stage of development for the treatment of Diabetic Foot Ulcer.

 

Esmolol : NovaLead Pharma

Esmolol (Galnobax) is a topical gel for non-healing chronic wounds. Galnobax is a repurposed generic drug molecule, which has recently completed Phase- III clinical trial in diabetic foot ulcer (DFU) successfully meeting both primary and secondary endpoints for both, safety and efficacy. The data from Phase III and Phase I/II studies substantiates pre-clinical findings that Galnobax® re-triggers natural wound healing processes impaired due to diabetic condition.

 

Donaperminogene seltoplasmid : Helixmith

Engensis (VM202) is an innovative gene therapy drug that provides fundamental treatment through tissue regeneration. Built on 20 years of experience in gene therapy, Engensis is designed to overcome the limitations of previous DNA plasmid candidates by expressing therapeutic levels of protein and inducing durable therapeutic effects. 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. HGF has a short half-life (5 minutes or less) and is quickly removed from the body by the liver, creating an obstacle to effective treatment with previous injectable recombinant HGF protein products. 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) for the treatment of painful diabetic peripheral neuropathy, making it the first RMAT-designated gene therapy for a prevalent disease with over one million patients. This designation grants all the benefits afforded by the fast track and breakthrough designations, including priority review, to Engensis.

 

TP 102 : Technophage

TP-102, the company’s first bacteriophage cocktail, for the treatment of infected diabetic foot ulcers caused by three different bacteria (Pseudomonas aeruginosa, Staphylococcus aureus and/or Acinetobacter baumannii). Technophage is currently conducting a Phase I/IIa clinical trial, to evaluate the safety and tolerability of TP-102 as a potential topical treatment for foot infections caused by critical pathogens in diabetic patients.

Further product details are provided in the report……..

Diabetic Foot Ulcer: Therapeutic Assessment

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

 

Major Players in Diabetic Foot Ulcer

There are approx. 35+ key companies which are developing the therapies for Diabetic Foot Ulcer. The companies which have their Diabetic Foot Ulcer drug candidates in the most advanced stage, i.e. Phase III, NovaLead Pharma.

 

Phases

DelveInsight’s report covers around 35+ 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 Foot Ulcer pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as 

  • Intra-articular
  • Intraocular
  • Intrathecal 
  • Intravenous
  • Ophthalmic
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical
  • Transdermal

 

Molecule Type

Products have been categorized under various Molecule types such as

  • Oligonucleotide
  • Peptide
  • Small molecule

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Diabetic Foot Ulcers: Pipeline Development Activities

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

Diabetic Foot Ulcers Report Insights

  • Diabetic Foot Ulcers Pipeline Analysis
  • Therapeutic Assessment
  • Unmet Needs
  • Impact of Drugs

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

Introduction

Executive Summary

Diabetic Foot Ulcer: 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

Diabetic Foot Ulcer– DelveInsight’s Analytical Perspective

Late Stage Products (Pre Registration)

  • Comparative Analysis

Drug name : Company name

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

End Stage Products (Phase III)

  • Comparative Analysis

Esmolol : NovaLead Pharma

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Mid Stage Products (Phase I/ II)

  • Comparative Analysis

TP 102 : Technophage

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Preclinical and Discovery Stage Products

  • Comparative Analysis

Drug name : Company Name

  • Product Description
  • Research and Development
  • Product Development Activities

Drug profiles in the detailed report…..

Inactive Products

  • Comparative Analysis

Diabetic Foot Ulcer Key Companies

Diabetic Foot Ulcer Key Products

Diabetic Foot Ulcer- Unmet Needs

Diabetic Foot Ulcer- Market Drivers and Barriers

Diabetic Foot Ulcer- Future Perspectives and Conclusion

Diabetic Foot Ulcer Analyst Views

Diabetic Foot Ulcer Key Companies

Appendix

List of Table

Table 1: Total Products for Diabetic Foot Ulcers

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 Products

List of Figures

Figure 1: Total Products for Diabetic Foot Ulcers

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    

• NovaLead Pharma
• Helixmith
• ShangHai HaiHe Pharmaceutical
• Beyond Air
• TaiGen Biotechnology
• RHEACELL
• Technophage
• Transwell Biotech
• Roche
• Chiesi Farmaceutici
• Blue Blood Biotech
• Cynata Therapeutics
• ZZ Biotech
• APstem Therapeutics
• Lewis and Clark Pharmaceuticals
• Destiny Pharma

 

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