A Comprehensive Monograph on Alogliptin (DB06203)

Section 1: Executive Summary and Drug Identification

1.1 Overview

Alogliptin is a potent, highly selective, and orally administered small molecule inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme.[1] It is clinically indicated as an adjunct to diet and exercise for the improvement of glycemic control in adult patients with type 2 diabetes mellitus (T2DM).[1] The therapeutic mechanism of Alogliptin is centered on the potentiation of the endogenous incretin system. By inhibiting DPP-4, Alogliptin prevents the rapid degradation of incretin hormones, primarily glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP). This action prolongs their physiological activity, leading to enhanced glucose-dependent insulin secretion from pancreatic β-cells and suppression of glucagon release from pancreatic α-cells, thereby lowering blood glucose levels.[2] Alogliptin is available for clinical use as a monotherapy agent and in fixed-dose combinations with other cornerstone antidiabetic medications, namely metformin and pioglitazone, to simplify treatment regimens and improve patient adherence.[2]

1.2 Drug Identification

Precise identification of a pharmaceutical agent is fundamental for research, clinical practice, and regulatory affairs. Alogliptin is known by several names and is cataloged across numerous international scientific and regulatory databases. While most sources are consistent, it is important to note a discrepancy in some commercial data, which incorrectly lists "Trajenta" as a synonym; Trajenta is the brand name for linagliptin, a distinct DPP-4 inhibitor.[8] Correcting this distinction is critical to avoid clinical confusion. The definitive identifiers for Alogliptin are consolidated in Table 1.

Table 1: Drug Identification and Nomenclature