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. 2026 Oct 5;17:1936459. doi: 10.3389/fphar.2026.1936459

FIGURE 2.

Infographic showing a wavy timeline of drug development stages: discovery and compound screening, toxicology and animal studies, phase I to III clinical trials, and regulatory submission and approval, with key tasks and years for each phase.

Research and Development History of Hybutimibe. The timeline shows the systematic process of hybutimibe from preclinical research to marketing application, reflecting the rigor of research and development for domestic innovative drugs. Pre-2011: Completion of compound screening and medicinal chemistry optimization, confirmation of selective NPC1L1 inhibitory activity; 2011-2013: Conduct of preclinical toxicology and animal experiments to verify safety, simultaneous initiation of Phase I clinical trials (2012–2013) to clarify pharmacokinetic characteristics and safety in healthy populations; 2014-2015: Phase II clinical trials to explore dose-effect relationship and verify preliminary lipid-lowering efficacy; 2015-2019: Phase III clinical trials to verify long-term efficacy and safety in a broad population; 2019-2021: Completion of regulatory submission and marketing approval in China, becoming the first domestic cholesterol absorption inhibitor. The timeline clearly presents the researchanddevelopment logic of hybutimibe, providing evidence-based support for its clinical application.