The PMDA’s view on the limited pipeline of nephrology drugs in Japan

In 2004, the nephrology community took an introspective look at the state of clinical trials for kidney disease and realized the subspecialty holds the dubious distinction of being in last place in the performance and completion of trials compared with other disciplines.1 However, some recent successes, including US Food and Drug Administration–approved drugs for autosomal dominant polycystic kidney disease, diabetic kidney disease, and anti–neutrophil cytoplasmic antibody–associated vasculitis and positive interventional trials in focal segmental glomerular sclerosis and lupus nephritis, provide cause for encouragement.

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