Diabetic Nephropathy - Pipeline Insight, 2025

The “Diabetic Nephropathy- Pipeline Insight, 2025” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Diabetic Nephropathy 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 Nephropathy: Understanding

Diabetic Nephropathy: Overview

Diabetic nephropathy, a serious complication of diabetes, occurs when high blood sugar levels damage the kidneys' delicate filtering system. The kidneys play a crucial role in filtering waste products from the blood, and when they are impaired, it can lead to kidney failure. This condition is a leading cause of end-stage renal disease (ESRD), necessitating dialysis or kidney transplantation for survival. Diabetic nephropathy typically develops over many years, often without noticeable symptoms until significant kidney damage has occurred.

Signs and symptoms of diabetic nephropathy may include persistent proteinuria (protein in the urine), swelling of the ankles, feet, or hands due to fluid retention (edema), increased need to urinate, especially at night (nocturia), fatigue, nausea, vomiting, unexplained weight loss, and decreased appetite. As the condition progresses, individuals may experience high blood pressure and worsening kidney function, leading to ESRD.The primary cause of diabetic nephropathy is prolonged exposure to high blood sugar levels. Chronically elevated glucose levels can damage the small blood vessels in the kidneys, impairing their ability to filter waste effectively. Other factors contributing to diabetic nephropathy include genetics, hypertension (high blood pressure), smoking, and dyslipidemia (abnormal levels of lipids in the blood).

Diagnosis of diabetic nephropathy typically involves urine tests to detect proteinuria and blood tests to assess kidney function. A urine albumin-to-creatinine ratio (UACR) test measures the amount of albumin (a type of protein) in the urine relative to creatinine, while blood tests measure serum creatinine levels and estimate the glomerular filtration rate (eGFR), which indicates how well the kidneys are filtering waste from the blood. Imaging studies such as ultrasound may also be used to assess the kidneys' structure and identify any abnormalities.Several risk factors increase the likelihood of developing diabetic nephropathy, including poorly controlled blood sugar levels, long-standing diabetes, high blood pressure, smoking, obesity, and a family history of kidney disease. Additionally, certain ethnic groups, such as African Americans, Hispanics, and Native Americans, have a higher risk of developing diabetic nephropathy.

Treatment aims to slow the progression of kidney damage, manage symptoms, and reduce the risk of complications. This typically involves tight control of blood sugar levels through diet, exercise, and medication, such as insulin or oral hypoglycemic agents. Blood pressure management is also crucial, often requiring medications such as angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs) to help protect the kidneys. Lifestyle modifications, including smoking cessation and maintaining a healthy weight, are essential for managing diabetic nephropathy. In advanced stages, dialysis or kidney transplantation may be necessary to sustain life. Early detection and proactive management of diabetes and its complications are vital for minimizing the impact of diabetic nephropathy on kidney function and overall health.

"Diabetic Nephropathy- Pipeline Insight, 2025" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Diabetic Nephropathy pipeline landscape is provided which includes the disease overview and Diabetic Nephropathy treatment guidelines. The assessment part of the report embraces, in depth Diabetic Nephropathy 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 Nephropathy 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 Nephropathy R&D. The therapies under development are focused on novel approaches to treat/improve Diabetic Nephropathy.

Diabetic Nephropathy Emerging Drugs Chapters

This segment of the Diabetic Nephropathy 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 Nephropathy Emerging Drugs

• SER150: Serodus AS

SER150 is an anti-inflammatory compound with a novel mode of action both inhibiting thromboxane synthase as well as blocking the thromboxane (TP) receptor. SER150 is expected to specifically inhibit the inflammatory processes in various segments of the diabetic kidney and reduce the progression of renal impairment whereby the amount of protein excreted in urine will decrease. Treatment with ACE-inhibitor antihypertensives is the golden standard of treatment of diabetic nephropathy but that treatment does not inhibit the fundamental causes of renal damage nor does it cure the disease. Newer antidiabetic drugs have demonstrated a decrease in loss of kidney function over time. Since the inflammation is a progressive process causing loss of the renal function, SER150 could potentially become a very significant combination (add-on) therapy as standard daily treatment in patients with diabetic kidney disease. It is expected that SER150 treatment delays progression or even prevents development of the disease. Consequently, SER150 may have a blockbuster market potential. Currently, the drug is in Phase II/III stage of its development for the treatment of diabetic kidney disease.

• CU01: Curacle

CU01 Dimethyl fumarate (DMF) which is being developed by Curacle. CU01 inhibits TGF-β/SMAD signaling by activating Nrf2 and has an excellent therapeutic effect in reducing renal fibrosis by suppressing the expression of extracellular matrix. In the previous clinical studies CU01 showed a significant improvement in the amount of change in eGFR from week 6 after administration, and the consistently increasing change in GFR continued until week 12. CU01 group suppressed the progression of diabetic nephropathy by gradually increasing eGFR during the administration period, so it is presumed to have an improvement effect on diabetic nephropathy. In the CU01 group, the ACR value at week 12 compared to the baseline was statistically significantly decreased (p=0.0441). Currently, the drug is in Phase II stage of its development for the treatment of diabetic nephropathy.

• CTA 382: Certa Therapeutics

CTA 382 is a novel small molecule therapy developed by Certa Therapeutics targeting chronic inflammatory and fibrotic diseases. It selectively inhibits the activity of key pro-inflammatory pathways involved in fibrosis and tissue damage. The drug is being investigated for conditions such as idiopathic pulmonary fibrosis (IPF) and chronic kidney disease (CKD) to improve clinical outcomes by reducing fibrosis and inflammation. Currently, the drug is in Preclinical stage of its development for the treatment of diabetic nephropathy.

Diabetic Nephropathy: Therapeutic Assessment

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

Major Players in Diabetic Nephropathy

• There are approx. 20+ key companies which are developing the therapies for Diabetic Nephropathy. The companies which have their Diabetic Nephropathy drug candidates in the most advanced stage, i.e. phase II/III include, Serodus AS.

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 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

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Product Type

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

Diabetic Nephropathy: Pipeline Development Activities

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

Diabetic Nephropathy Report Insights

• Diabetic Nephropathy Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Serodus AS
• Curacle
• Certa Therapeutics
• Cosette Pharmaceuticals
• Boehringer Ingelheim
• Lewis and Clark Pharmaceuticals
• Shanghai Alebund Pharmaceuticals
• Celros Biotech
• Inversago Pharma Inc.
• Akebia Therapeutics
• Palatin Technologies, Inc
• Chinook Therapeutics

Key Products

• SER150
• CU01
• CTA 382
• Bremelanotide
• BI 685509
• Research programme: adenosine A2A receptor agonists
• AP 303
• CRB A4
• INV-202
• IW-1973
• MCr Agonist
• Atrasentan

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