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U.S. development Phase success rates for rare and common disease drugs 2006-2015

Probability of success for new rare disease and high prevalence disease drugs in the U.S. by development phase from 2006 to 2015

The data displays the probability of success for new rare disease and high prevalence disease drugs in the United States through the various stages of development, from January 1, 2006 to December 31, 2015. It was found that while the probability that a new drug for a chronic high prevalence disease makes it from Phase I to approval was only 8.7 percent, it was 25.3% for rare disease drugs.

Phase I to phase II 63 58 76
Phase II to phase III 30 27 50
Phase III to NDA/BLA 58 61 73
NDA/BLA to approval 85 87 89
Phase I to approval 9.6 8.7 25.3