Diabetic Foot Ulcers Pipeline Insight 2025: 25+ Regenerative, Antimicrobial, and Device-Based Therapies Advancing Toward Faster Healing and Limb Preservation | DelveInsight

DelveInsight's "Diabetic Foot Ulcers - Pipeline Insight, 2025" survey examines more than 25 therapies in development that address diabetic foot ulcers (DFUs), a leading cause of morbidity and lower-limb amputation in individuals with diabetes. Despite improvements in wound care protocols, offloading, and revascularization techniques, many patients experience chronic, non-healing wounds that drive hospitalizations, healthcare costs, and poor quality of life-highlighting substantial unmet clinical need.

The DFU pipeline is rapidly diversifying across regenerative biologics (including mesenchymal stem cell therapies, exosome preparations, and engineered skin substitutes), growth-factor and cytokine-based products, and novel antimicrobial strategies, such as peptide therapeutics and microbiome-modulating approaches. Advanced wound dressings, bioactive extracellular-matrix scaffolds, enzymatic debridement agents, and combination products that integrate drug delivery with negative-pressure wound therapy are also prominent. Systemic small molecules and gene-therapy approaches aimed at improving angiogenesis, modulating inflammation, and enhancing extracellular-matrix remodeling are entering earlier clinical stages.

With several late-stage regenerative products and device-drug combination candidates progressing toward pivotal evaluation, the DFU landscape is poised for meaningful change. Precision-driven, tissue-regenerative, and infection-targeted strategies promise to shorten time-to-heal, reduce recurrence and amputations, and improve functional outcomes-reshaping standards of care for patients living with chronic diabetic foot ulcers.

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

Key Takeaways from the Diabetic Foot Ulcers Pipeline Report
• DelveInsight's Diabetic Foot Ulcers Pipeline analysis depicts a robust space with 20+ active players working to develop 25+ pipeline drugs for Diabetic Foot Ulcers treatment.
• The leading Diabetic Foot Ulcers companies include Energenesis Biomedical Co., Ltd, Microbion Corporation, Rion Inc., Aurealis Oy, BioTissue Holdings, Inc, Technophage, SA, Biocomposites Ltd, PolarityTE, NOxy Health Products, LLC, Cytora Ltd., Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd., Anterogen Co., Ltd., Cell2Cure ApS, Lakewood-Amedex Inc, FibroBiologics, and others are evaluating their lead assets to improve the Diabetic Foot Ulcers treatment landscape.
• Key Diabetic Foot Ulcers pipeline therapies in various stages of development include ENERGI-F703 GEL, Topical Pravibismane, PEP (Purified Exosome Product), AUP1602-C, TTAX01, TP-102, STIMULAN VG, SkinTE, NOX1416, hOMSC200, Antimicrobial Peptide PL-5 Topical Spray, ALLO-ASC-DFU, Cell2Cure, Nu-3 gel, CYW 628, and others.
• In July 2025, Eluciderm, Inc. announced FDA clearance of its Investigational New Drug (IND) ELU42 for a Phase 1/2a study. ELU42 is a topical small-molecule Wnt modulator with bacteriostatic properties, being evaluated for safety and efficacy in patients with diabetic foot ulcers (DFUs), aiming to promote healing and regenerative repair of chronic wounds.
• In March 2025, Orthofix Medical Inc. (NASDAQ: OFIX), a global leader in medical technology, announced it obtained FDA 510(k) clearance and the European CE Mark for its TrueLokTM Elevate Transverse Bone Transport (TBT) System.
• In February 2025, PolarityBio announced that its regenerative tissue product, SkinTE, received Breakthrough Therapy Designation (BTD) from the U.S. FDA for treating Wagner Grade 1 Diabetic Foot Ulcers (DFU).

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Diabetic Foot Ulcers Overview
Diabetic Foot Ulcers (DFUs) are a common and serious complication of diabetes, resulting from a combination of factors such as peripheral neuropathy, poor circulation, and impaired wound healing. These open sores or wounds typically develop on the feet, especially the soles, and can become infected if not treated promptly. DFUs not only reduce quality of life but also carry a high risk of hospitalization and amputation. Early detection, proper wound care, blood sugar control, and pressure offloading are crucial to prevent complications and promote healing.

Find out more about Diabetic Foot Ulcers medication @ https://www.delveinsight.com/report-store/diabetic-foot-ulcers-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Diabetic Foot Ulcers Treatment Analysis: Drug Profile
ENERGI-F703 GEL: Energenesis Biomedical Co., Ltd.
ENERGI-F703 is a topical gel designed to accelerate the healing of diabetes-related wounds by activating AMPK within cells, thereby increasing ATP levels in tissues surrounding the wound. Preclinical studies, including cellular and animal models, demonstrate multiple beneficial effects of ENERGI-F703. The gel reduces inflammation in endothelial cells of blood vessels, enhances fibroblast fibrosis, promotes collagen deposition, and supports granulation tissue formation. Additionally, it facilitates wound healing by stimulating epithelial cell migration. Studies using diabetic model mice confirm its efficacy in accelerating wound recovery. Currently, ENERGI-F703 is in Phase III clinical trials for the treatment of Diabetic Foot Ulcers.

Topical Pravibismane: Microbion Corporation
Topical pravibismane, formulated as a hydrogel suspension (MBN-101), offers significant potential for treating diabetic foot infections (DFIs) due to its dual broad-spectrum antimicrobial and anti-biofilm properties. It effectively targets antibiotic-resistant bacterial strains, addressing a major limitation of standard treatments, which often fail to prevent severe complications such as lower limb amputations, prolonged hospitalizations, and high treatment costs. Pravibismane has received Qualified Infectious Disease Product (QIDP) designation and Fast Track status from the US FDA for its role in the adjunctive treatment of moderate to severe diabetic foot ulcer infections. The drug is currently in Phase II clinical development for the treatment of Diabetic Foot Ulcers.

Learn more about the novel and emerging Diabetic Foot Ulcers pipeline therapies @ https://www.delveinsight.com/report-store/diabetic-foot-ulcers-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Diabetic Foot Ulcers 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 Foot Ulcers Pipeline Report
• Coverage: Global
• Key Diabetic Foot Ulcers Companies: Energenesis Biomedical Co., Ltd, Microbion Corporation, Rion Inc., Aurealis Oy, BioTissue Holdings, Inc, Technophage, SA, Biocomposites Ltd, PolarityTE, NOxy Health Products, LLC, Cytora Ltd., Jiangsu ProteLight Pharmaceutical & Biotechnology Co., Ltd., Anterogen Co., Ltd., Cell2Cure ApS, Lakewood-Amedex Inc, FibroBiologics, and others.
• Key Diabetic Foot Ulcers Pipeline Therapies: ENERGI-F703 GEL, Topical Pravibismane, PEP (Purified Exosome Product), AUP1602-C, TTAX01, TP-102, STIMULAN VG, SkinTE, NOX1416, hOMSC200, Antimicrobial Peptide PL-5 Topical Spray, ALLO-ASC-DFU, Cell2Cure, Nu-3 gel, CYW 628, and others.

Dive deep into rich insights for drugs used for Diabetic Foot Ulcers treatment; visit @ https://www.delveinsight.com/report-store/diabetic-foot-ulcers-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

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

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.