U.S. development Phase success rates for rare and common disease drugs 2011-2020

Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2011 to 2020

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Release date

February 2021


United States

Survey time period

January 1, 2011, to November 30, 2020

Supplementary notes

Only company-sponsored, FDA registration-enabling development programs were included in this analysis. Investigator-sponsored studies and combinations with other investigational drugs were excluded.
* NDA - New Drug Application / BLA - Biologic License Application.

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