Only company-sponsored, FDA registration-enabling development
programs were included in this analysis. Investigator-sponsored studies and combinations with other
investigational drugs were excluded.
Citation formats
U.S. drug development phase I to approval success rates 2011-2020 by disease area
This statistic shows the likelihood of approval from Phase I for new drugs in the U.S., within the period from , to **, by disease area. It was found that the likelihood of approval from Phase I of drug development was highest for drugs in hematology.
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Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors. (February 26, 2021). Likelihood of approval from phase I for new drugs in select disease areas in the U.S. between 2011 and 2020 [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 28, 2026, from /statistics/597676/drug-development-phase-one-to-approval-probability-of-success/
Biotechnology Innovation Organization, und Pharma Intelligence, und QLS Advisors. "Likelihood of approval from phase I for new drugs in select disease areas in the U.S. between 2011 and 2020." Chart. February 26, 2021. ÌÇÐÄÆƽâ°æ. Accessed July 28, 2026. /statistics/597676/drug-development-phase-one-to-approval-probability-of-success/
Biotechnology Innovation Organization, Pharma Intelligence, QLS Advisors. (2021). Likelihood of approval from phase I for new drugs in select disease areas in the U.S. between 2011 and 2020. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 28, 2026. /statistics/597676/drug-development-phase-one-to-approval-probability-of-success/
Biotechnology Innovation Organization, and Pharma Intelligence, and QLS Advisors. "Likelihood of Approval from Phase I for New Drugs in Select Disease Areas in The U.S. between 2011 and 2020." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 26 Feb 2021, /statistics/597676/drug-development-phase-one-to-approval-probability-of-success/
Biotechnology Innovation Organization & Pharma Intelligence & QLS Advisors, Likelihood of approval from phase I for new drugs in select disease areas in the U.S. between 2011 and 2020 ÌÇÐÄÆƽâ°æ, /statistics/597676/drug-development-phase-one-to-approval-probability-of-success/ (last visited July 28, 2026)
Likelihood of approval from phase I for new drugs in select disease areas in the U.S. between 2011 and 2020 [Graph], Biotechnology Innovation Organization, & Pharma Intelligence, & QLS Advisors, February 26, 2021. [Online]. Available: /statistics/597676/drug-development-phase-one-to-approval-probability-of-success/
