Approval success rates of drug candidates based on target, action, modality, application, and their combinations

Shingo Yamaguchi; Masayuki Kaneko; Mamoru Narukawa

doi:10.1111/cts.12980

journal article Open Access Apr 08, 2021

Approval success rates of drug candidates based on target, action, modality, application, and their combinations

Shingo Yamaguchi

Masayuki Kaneko

Mamoru Narukawa

Clinical and Translational Science Vol. 14 No. 3 pp. 1113-1122 · Wiley

View at Publisher Save 10.1111/cts.12980

Abstract

AbstractThe current success rate of a drug candidate, from the beginning of the clinical trial to receiving marketing approval, is about 10%–20%, and it has not changed during the past few decades. Therefore, pharmaceutical companies are under pressure to select one compound, among many others, with a high probability of success. The differences in drug features affect their probabilities of approval success. In this study, we examined the approval success rates of drug candidates, developed in the United States, the European Union, or Japan, by focusing on four parameters (“drug target,” “drug action,” “drug modality,” and “drug application”) and their combinations, and identified factors that conditioned the outcome of the drug development process. We obtained a total success rate of 12.8%, after evaluating 3999 compounds. Moreover, after analyzing the combinations of these parameters, the approval success rates of drugs that corresponded to the following categories—a stimulant in drug action or an enzyme in drug target and biologics (excluding monoclonal antibody) in drug modality—were high (34.1% and 31.3%, respectively). Univariate and multivariate logistic regression analyses revealed that stimulant in drug action, and “B” (blood and blood forming organs), “G” (genito‐urinary system and sex), and “J” (anti‐infectives for systemic use) in drug application were statistically associated with high approval success rates. We found several parameters and their combinations that affected drug approval success rates. Our results could assist pharmaceutical companies in evaluating the probability of success of their drug candidates and, thus, in efficiently conducting the clinical development process.

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Details

Published: Apr 08, 2021
Vol/Issue: 14(3)
Pages: 1113-1122
License: View

Authors

S

Shingo Yamaguchi

Department of Clinical Medicine (Pharmaceutical Medicine) Graduate School of Pharmaceutical Sciences Kitasato University Minato‐ku Tokyo Japan; GlaxoSmithKline K.K. Tokyo Japan

M

Masayuki Kaneko

Department of Clinical Medicine (Pharmaceutical Medicine) Graduate School of Pharmaceutical Sciences Kitasato University Minato‐ku Tokyo Japan

M

Mamoru Narukawa

Department of Clinical Medicine (Pharmaceutical Medicine) Graduate School of Pharmaceutical Sciences Kitasato University Minato‐ku Tokyo Japan

Cite This Article

Shingo Yamaguchi, Masayuki Kaneko, Mamoru Narukawa (2021). Approval success rates of drug candidates based on target, action, modality, application, and their combinations. Clinical and Translational Science, 14(3), 1113-1122. https://doi.org/10.1111/cts.12980

Approval success rates of drug candidates based on target, action, modality, application, and their combinations

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