RECENTLY APPROVED ANTIDIABETIC DRUGS BY FDA AND METABOLITE CHARACTERIZATION STUDIES USING LC/MS: A COMPREHENSIVE REVIEW

Abstract

Type 2 diabetes mellitus (T2DM) represents a significant global health burden, with over 38 million Americans currently affected. The FDA has approved nearly 60 antidiabetic agents, with continuous expansion of therapeutic options including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), sodium-glucose cotransporter-2 inhibitors (SGLT2i), and novel co-agonists. This review synthesizes recent FDA approvals in antidiabetic therapeutics (2023-2025), with particular emphasis on GLP-1 RAs, SGLT2 inhibitors, and emerging combination therapies. Additionally, this paper comprehensively discusses the role of liquid chromatography-mass spectrometry (LC/MS) in metabolite identification and characterization studies, including FDA compliance protocols and method validation guidelines. The review highlights key regulatory considerations, including GLP status, bioanalytical method validation parameters, and metabolite profiling strategies relevant to drug development. This work synthesizes current literature, regulatory guidance, and clinical data to provide a comprehensive understanding of modern antidiabetic drug development and metabolite assessment methodologies.