U.S. drug development phase success rates 2011-2020

Published by
Matej Mikulic,
Jun 3, 2022
This statistic shows the probability of success for new drugs in the U.S. through the various stages of development, within the period from January 1, 2011, to November 30, 2020. It was found that the probability that a new drug makes it from phase I to phase II was 52 percent.

Probability of success for drugs in the U.S. in different development phases between 2011 and 2020

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Release date

February 2021

Region

United States

Survey time period

January 1, 2011, to November 30, 2020

Supplementary notes

For all diseases and modalities. 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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