Diabetic Nephropathy Pipeline 2025: FDA Approvals, Therapies, Clinical Trials, And Latest Developments Unveiled By Delveinsight Helixmith, Lexicon Pharmaceuticals, Glenmark Pharmaceuticals, Regenacy

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As per DelveInsight's assessment, globally, Diabetic Nephropathy pipeline constitutes 20+ key companies continuously working towards developing 25+ Diabetic Nephropathy treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

“Diabetic Nephropathy Pipeline Insight, 2025 " report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Diabetic Nephropathy Market.

The Diabetic Nephropathy Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

Some of the key takeaways from the Diabetic Nephropathy Pipeline Report:

• Companies across the globe are diligently working toward developing novel Diabetic Nephropathy treatment therapies with a considerable amount of success over the years.

• Diabetic Nephropathy companies working in the treatment market are Praetego, Mitsubishi Tanabe Pharma, Regenacy Pharmaceuticals, WinSanTor, Helixmith, Lexicon Pharmaceuticals, Glenmark Pharmaceuticals, Regenacy Pharmaceuticals, Pure Green, Vertex Pharmaceuticals Incorporated, Eli Lilly and Company, and others, are developing therapies for the Diabetic Nephropathy treatment

• Emerging Diabetic Nephropathy therapies in the different phases of clinical trials are- PTG-630, MT-8554, Ricolinostat, WST 057, Engensis, VM202, LX9211, GRC 17536, Ricolinostat, CBD, VX-548, LY3857210, and others are expected to have a significant impact on the Diabetic Nephropathy market in the coming years.

• In December 2024, Palatin Technologies, Inc. (NYSE American: PTN) , a biopharmaceutical company specializing in developing first-in-class medicines that modulate the melanocortin receptor system, has announced the topline results from the BREAKOUT study. The BREAKOUT study is a Phase IIb, multicenter, open-label, prospective trial investigating the efficacy of BREmelanotide in Diabetic Kidney Disease. The study aimed to assess the reduction of urinary protein and the maintenance of podocyte density and function. The BREAKOUT Study (BMT-701) included 16 patients with confirmed Type 2 diabetic nephropathy and a UP/Cr ratio greater than 1000 mg/gm, with 8 patients completing the six-month treatment regimen at multiple U.S. sites. Patients were administered bremelanotide subcutaneously twice daily, along with the maximum tolerated dose of renin-angiotensin-aldosterone system (RAAS) inhibitors and followed up throughout the study.

• In March 2024, China-based Hua Medicine plans to focus on advancing its type 2 diabetes (T2D) drug for diabetic kidney patients in the US. Chief Strategy Officer George Lin shared with Clinical Trials Arena that the company aims to develop a once-daily version of its drug, Huatangning (dorzagliatin), for the US market. The company has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the second-generation version of HuaTangNing, after conducting four Phase I trials in the US for the twice-daily formulation, which is currently marketed in China in collaboration with Bayer.

Diabetic Nephropathy Overview

Diabetic Nephropathy is a type of kidney disease that occurs as a complication of diabetes. It involves damage to the small blood vessels in the kidneys due to prolonged high blood sugar levels, leading to impaired kidney function. The condition progresses in stages, often beginning with microalbuminuria (small amounts of protein in the urine) and eventually advancing to more severe kidney damage, potentially leading to end-stage renal disease (ESRD). Diabetic nephropathy is a leading cause of kidney failure and is managed through blood sugar control, blood pressure management, and, in severe cases, dialysis or kidney transplantation.

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Emerging Diabetic Nephropathy Drugs Under Different Phases of Clinical Development Include:

• PTG-630: Praetego

• MT-8554: Mitsubishi Tanabe Pharma

• Ricolinostat: Regenacy Pharmaceuticals

• WST 057: WinSanTor

• Engensis: Helixmith

• VM202: Helixmith

• LX9211: Lexicon Pharmaceuticals

• GRC 17536: Glenmark Pharmaceuticals

• Ricolinostat: Regenacy Pharmaceuticals

• CBD: Pure Green

• VX-548: Vertex Pharmaceuticals Incorporated

• LY3857210: Eli Lilly and Company

Diabetic Nephropathy Route of Administration

Diabetic Nephropathy pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Infusion

• Intradermal

• Intramuscular

• Intranasal

• Oral

• Parenteral

• Subcutaneous

• Topical.

• Molecule Type

Diabetic Nephropathy Molecule Type

Diabetic Nephropathy Products have been categorized under various Molecule types, such as

• Gene therapies

• Small molecule

• Product Type

Diabetic Nephropathy Pipeline Therapeutics Assessment

• Diabetic Nephropathy Assessment by Product Type

• Diabetic Nephropathy By Stage and Product Type

• Diabetic Nephropathy Assessment by Route of Administration

• Diabetic Nephropathy By Stage and Route of Administration

• Diabetic Nephropathy Assessment by Molecule Type

• Diabetic Nephropathy by Stage and Molecule Type

DelveInsight's Diabetic Nephropathy 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)

• Pre-clinical and Discovery stage candidates

• Discontinued & Inactive candidates

• Route of Administration

Further Diabetic Nephropathy product details are provided in the report. Download the Diabetic Nephropathy pipeline report to learn more about the emerging Diabetic Nephropathy therapies

Some of the key companies in the Diabetic Nephropathy Therapeutics Market include:

Key companies developing therapies for Diabetic Nephropathy are - Eli Lilly and Company, CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Aptinyx, Lexicon Pharmaceuticals, Lateral Pharma Pty Ltd., SIMR (Australia) Biotech Pty Ltd., WinSanTor, Inc., Helixmith, Lexicon Pharmaceuticals, Glenmark Pharmaceuticals, Regenacy Pharmaceuticals, Pure Green, Vertex Pharmaceuticals Incorporated, Daiichi Sankyo, Inc., Avazzia, Inc., and others.

Diabetic Nephropathy Pipeline Analysis:

The Diabetic Nephropathy pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Diabetic Nephropathy with aggregate therapies developed by each company for the same.

• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Diabetic Nephropathy Treatment.

• Diabetic Nephropathy key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.

• Diabetic Nephropathy Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.

• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Diabetic Nephropathy market.

The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

Download Sample PDF Report to know more about Diabetic Nephropathy drugs and therapies

Diabetic Nephropathy Pipeline Market Drivers

• Increasing prevalence of diabetes cases and growing aging population, rising R&D activities for drug discovery and development are some of the important factors that are fueling the Diabetic Nephropathy Market.

Diabetic Nephropathy Pipeline Market Barriers

• However, high failure rate in clinical trials, stringent regulatory requirements, and longer approval time for drugs and other factors are creating obstacles in the Diabetic Nephropathy Market growth.

Scope of Diabetic Nephropathy Pipeline Drug Insight

• Coverage: Global

• Key Diabetic Nephropathy Companies: Praetego, Mitsubishi Tanabe Pharma, Regenacy Pharmaceuticals, WinSanTor, Helixmith, Lexicon Pharmaceuticals, Glenmark Pharmaceuticals, Regenacy Pharmaceuticals, Pure Green, Vertex Pharmaceuticals Incorporated, Eli Lilly and Company, and others

• Key Diabetic Nephropathy Therapies: PTG-630, MT-8554, Ricolinostat, WST 057, Engensis, VM202, LX9211, GRC 17536, Ricolinostat, CBD, VX-548, LY3857210, and others

• Diabetic Nephropathy Therapeutic Assessment: Diabetic Nephropathy current marketed and Diabetic Nephropathy emerging therapies

• Diabetic Nephropathy Market Dynamics: Diabetic Nephropathy market drivers and Diabetic Nephropathy market barriers

Request for Sample PDF Report for Diabetic Nephropathy Pipeline Assessment and clinical trials

Table of Contents

1. Diabetic Nephropathy Report Introduction

2. Diabetic Nephropathy Executive Summary

3. Diabetic Nephropathy Overview

4. Diabetic Nephropathy- Analytical Perspective In-depth Commercial Assessment

5. Diabetic Nephropathy Pipeline Therapeutics

6. Diabetic Nephropathy Late Stage Products (Phase II/III)

7. Diabetic Nephropathy Mid Stage Products (Phase II)

8. Diabetic Nephropathy Early Stage Products (Phase I)

9. Diabetic Nephropathy Preclinical Stage Products

10. Diabetic Nephropathy Therapeutics Assessment

11. Diabetic Nephropathy Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Diabetic Nephropathy Key Companies

14. Diabetic Nephropathy Key Products

15. Diabetic Nephropathy Unmet Needs

16 . Diabetic Nephropathy Market Drivers and Barriers

17. Diabetic Nephropathy Future Perspectives and Conclusion

18. Diabetic Nephropathy Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach.

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