About This Statistic
This statistic displays the median number of required patients for orphan and non-orphan products in phase III trial as of 2015. There is a median number of 538 patients needed for orphan drug phase III trials. Orphan drugs are used to target rare diseases or disorders, which in the United States is defined as less than 200,000 patients. The development of orphan drugs are currently incentivized in the United States through the Orphan Drug Act of 1983.