Diabetic nephropathy is a complication of diabetes characterised by damage to the kidneys filtering system. It hampers the ability of kidneys to remove waste products and extra fluid from body. Some of the most common symptoms of diabetic nephropathy include high blood pressure, fatigue, anorexia, headache, skin dryness, and swelling of limbs. The most common risk factors of diabetic nephropathy include diabetes, high blood sugar, high blood pressure, smoking, and heredity. Approximately 40% of people with diabetes eventually develop kidney disease. According to an estimate approximately 180,000 people are suffering from kidney failure caused by diabetes.
The main growth drivers for the therapeutic pipeline of diabetic nephropathy are increasing investment in research and development of new drugs for the disease, rising prevalence of diabetes and obesity, elevated awareness about diabetes and kidney-related disorders. According to International Diabetes Federation the prevalence of diabetes worldwide is 415 million people globally and it is estimated to reach to 642 million people by 2040.
In recent years, many big pharmaceutical companies have invested significant amount of capital on the research and development of drugs for nephropathy. In March 2017, Ironwood Pharmaceuticals, Inc. announced that it will initiate a Phase II clinical trial investigating IW-1973 in diabetic nephropathy. IW-1973 is an investigational soluble guanylate cyclase (sGC) stimulator which plays an important role in regulating diverse physiological processes such as blood flow, inflammation, fibrosis, and metabolism. The company expects that IW-1973 could generate annual peak sales of more than $5.0 billion, globally.
In August 2015, Bayer HealthCare announced to expand its clinical development program for finerenone (BAY 94-8862). Finerenone is a non-steroidal mineralocorticoid receptor antagonist with three Phase III studies. The planned Phase III study will investigate finerenone compared to eplerenone in chronic heart failure patients with reduced ejection fraction and type 2 diabetes mellitus and / or chronic kidney disease in more than 35 countries. The studies were designed to evaluate the efficacy and safety of finerenone in patients with diabetic kidney disease, and in patients with chronic heart failure. In October 2014, twoXAR, Inc. collaborated with scientists from the Icahn School of Medicine at Mount Sinai to validate computational approaches in early-stage drug discovery for diabetic nephropathy. In August 2014, AstraZeneca plc and Mitsubishi Tanabe Pharma entered into a research collaboration for diabetic nephropathy focused on early-stage research. The companies expect to discover promising drug candidates much faster in collaboration than working alone.
In 2013, AbbVie, Inc. initiated Phase III clinical trial of its investigational compound atrasentan for treatment of diabetic nephropathy. Atrasentan is a selective endothelin-A receptor antagonists, which antagonizes the effect of endothelin-l (ET-l), a peptide involved in constriction of blood vessels in the kidney.
The major market players having drugs in pipeline for diabetic nephropathy includes Eli Lilly and Company, Reata Pharmaceuticals, Inc., Abbott Laboratories, AbbVie Inc., Bayer AG, Novartis AG, Pfizer, Inc., Mitsubishi Tanabe Pharma Corporation, and Daiichi Sankyo Co., Ltd., ChemoCentryx Inc., Mallinckrodt Pharmaceuticals and GenKyoTex S.A.