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Abstract

Alogliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor used in the management of type 2 diabetes mellitus. Developed by Takeda Pharmaceutical Company, it offers an alternative to other DPP-4 inhibitors in the market. This paper provides an in-depth analysis of alogliptin, covering its chemical properties, development timeline, market presence, competitive landscape, and the impact of generic formulations.

Keywords

Alogliptin, DPP-4 inhibitor, type 2 diabetes mellitus, chemical properties, market analysis, global sales, generics.

Introduction

Alogliptin, marketed under the brand names Nesina and Vipidia, is an oral medication prescribed for the treatment of type 2 diabetes mellitus. As a member of the DPP-4 inhibitor class, it functions by enhancing insulin secretion and inhibiting glucagon release, thereby improving glycemic control.

Chemical Properties

The chemical formula of alogliptin is C18H21N5O2, with a molar mass of approximately 339.4 g·mol−1. Its IUPAC name is 2-({6-[(3R)-3-Aminopiperidin-1-yl]-3-methyl-2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl}methyl)benzonitrile. The structural design of alogliptin contributes to its selective inhibition of DPP-4, distinguishing it from other proteases.

Development and Approval Timeline

Alogliptin was developed by Syrrx, a company acquired by Takeda Pharmaceutical Company in 2005. The development process involved replacing quinazolinone with pyrimidinedione to enhance metabolic stability and selectivity. Takeda submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in December 2007, following positive Phase III trial results. However, the initial application was not approved, leading to additional data submissions. In 2013, the FDA approved alogliptin in three formulations: as a standalone medication (Nesina), in combination with metformin (Kazano), and with pioglitazone (Oseni).

Time on the Market

Since its approval in 2013, alogliptin has been available in the United States for over a decade. Its presence in the market reflects its role as a therapeutic option for patients with type 2 diabetes mellitus.

Global Sales and Market Competition

While specific global sales figures for alogliptin are not publicly disclosed, its market position is influenced by competition from other DPP-4 inhibitors such as sitagliptin, saxagliptin, and linagliptin. The diabetes medication market is characterized by a variety of treatment options, including both oral and injectable therapies, catering to diverse patient needs.

Generics and Related Developments

The expiration of alogliptin's patent has led to the development of generic versions, increasing accessibility and affordability for patients. Generic formulations play a crucial role in healthcare by providing cost-effective alternatives to brand-name drugs, thereby improving patient adherence to treatment regimens.

Conclusion

Alogliptin represents a significant advancement in the pharmacological management of type 2 diabetes mellitus. Its development, characterized by strategic chemical modifications, has resulted in a medication that offers efficacy with a favorable side effect profile. The introduction of generics has further expanded its reach, underscoring the importance of such therapies in global diabetes care.

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References or other information:

Wikipedia about Alogliptin
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