REVIEW article
Front. Endocrinol.
Sec. Diabetes: Molecular Mechanisms
Volume 16 - 2025 | doi: 10.3389/fendo.2025.1601119
This article is part of the Research TopicAdvances in Novel Pharmacotherapeutics and Drug Discovery: Computational, Experimental, Translational, and Clinical Models, Volume IIView all 8 articles
Impact of structure and formulation changes on the function of insulin products
Provisionally accepted
- United States Food and Drug Administration, Silver Spring, United States
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Insulin has played an important role in the treatment of diabetes since its discovery in the early 1920s. Initially derived from animal sources, insulin production underwent significant changes with the advent of recombinant DNA technology, allowing for the development of insulin analogs and biosimilar products. Through scientific and technological advances, various types of insulin have been engineered to cater to diverse patient populations, improving the quality, safety, efficacy, and accessibility of these products. There are currently over 50 insulin products approved by the U.S. Food and Drug Administration (FDA), each tailored to meet specific therapeutic needs. This review traces the journey of insulin, from its discovery and purification to recombinant DNA technology, biosimilar developments, and recent advancements in formulation including ultra-rapid formulations and combination therapies. The review also examines the impact of structural and formulation modifications on the pharmacokinetics and pharmacodynamics of insulin, resulting in a range of insulin products with different time-action profiles (rapid-, short-, intermediate-, and long-acting insulins). These technological and manufacturing developments have improved the quality of insulin products available to the public and have made insulin therapy safer, more effective, and more adaptable to individual patient needs, greatly enhancing the management of diabetes over time and patient quality of life. Disclaimer: This article reflects the views of the authors and should not be construed to represent US FDA's views or policies.
Keywords: insulin analogs, Glucose, pharmacometrics, diabetes, Metabolism
Received: 27 Mar 2025; Accepted: 21 Oct 2025.
Copyright: © 2025 Yang, Shahinozzaman, Shin, Bupp and Sourbier. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Carole Sourbier, carole.sourbier@fda.hhs.gov
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.