Required number of patients for phase III trials of orphan and non-orphan drugs as of 2015*

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Median number of patients required
Orphan538
Non-orphan1,558
All921
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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.

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