When will sparsentan/sparsentan be available? Domestic and overseas listing time and approval progress tracking

As an innovative drug, Sparsentan has been approved and marketed in many countries. The drug was first developed by Eckerd Pharma in the United States and has undergone clinical trials and approval processes in many countries and regions.

In the United States, sparsentan was approved by the U.S. Food and Drug Administration (FDA) in 2021 for the treatment of adults with primary immunoglobulin A nephropathy (IgAN), particularly those with hyperalbuminuria. The approval was based on the results of a clinical trial called "PROTECT", which showed that sparsentan has significant efficacy in improving proteinuria and protecting kidney function. The approval of the US FDA makes sparsentan a new treatment option for the treatment of IgA nephropathy, especially for patients who have failed to respond to traditional treatments.

As for Europe, spaxentan is also undergoing the approval process and is expected to receive approval from the European Medicines Agency (EMA) in the near future. As early as 2020, sparsentan has entered the EMA's approval process, and based on the drug's clinical trial data, it is expected to be approved smoothly. Although the market for sparsentane in Europe is not yet fully open, as approval progresses, patients are expected to have access to the drug in the European market in the next few years.

In China, the launch of Sparsentan has been relatively slow. Although the drug has made significant progress in many countries and regions around the world, the approval process in China is still ongoing. At present, the market of sparsentane in China has not yet been opened, and the relevant clinical trials and approval processes are still in progress. According to industry expert analysis, as the drug has great clinical demand in the field of chronic kidney disease, China's regulatory agencies are expected to approve the drug's marketing in the next few years.

Reference materials:https://www.sparsentan.com/