TY - JOUR A1 - Schuhmacher, Alexander A1 - Hinder, Markus A1 - Brief, Elazar A1 - Gassmann, Oliver A1 - Hartl, Dominik T1 - Benchmarking R&D success rates of leading pharmaceutical companies: an empirical analysis of FDA approvals (2006–2022) JF - Drug Discovery Today N2 - Previous analyses provide an industry benchmark of ∼10% for the success rate in clinical development. However, prior analyses were limited by a narrow timeframe, a diverse research focus, biases in phase-to-phase transition methodology or a focus on specific use cases. We calculated unbiased input:output ratios (Phase I to FDA new drug approval) to analyze the likelihood of first approval using data from clinicaltrials.gov, encompassing a total of 2092 active ingredients, 19 927 clinical trials conducted by 18 leading pharmaceutical companies (2006–2022) and 274 new drug approvals. Our study reveals an average likelihood of first approval rate of 14.3% across leading research-based pharmaceutical companies, broadly ranging from 8% to 23%. UR - https://doi.org/10.1016/j.drudis.2025.104291 Y1 - 2025 UR - https://doi.org/10.1016/j.drudis.2025.104291 UR - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:573-56382 SN - 1878-5832 N1 - Corrigendum verfügbar unter https://doi.org/10.1016/j.drudis.2025.104326 VL - 30 IS - 2 PB - Elsevier CY - Amsterdam ER -