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Current Diabetes Reviews

Eiditor-in-Chief

ISSN (Print): 1573-3998
ISSN (Online): 1875-6417

Review Article

Addressing Unmet Medical Needs in Type 1 Diabetes: A Review of Drugs Under Development

Author(s): Friedrich Mittermayer*, Erica Caveney, Claudia De Oliveira, G. Alexander Fleming, Loukas Gourgiotis, Mala Puri, Li-Jung Tai and J. Rick Turner

Volume 13 , Issue 3 , 2017

Page: [300 - 314] Pages: 15

DOI: 10.2174/1573399812666160413115655

Price: $58

Abstract

Introduction: The incidence of type 1 diabetes (T1D) is increasing worldwide and there is a very large need for effective therapies. Essentially no therapies other than insulin are currently approved for the treatment of T1D. Drugs already in use for type 2 diabetes and many new drugs are under clinical development for T1D, including compounds with both established and new mechanisms of action.

Content of the Review: Most of the new compounds in clinical development are currently in Phase 1 and 2. Drug classes discussed in this review include new insulins, SGLT inhibitors, GLP-1 agonists, immunomodulatory drugs including autoantigens and anti-cytokines, agents that regenerate β-cells and others.

Regulatory Considerations: In addition, considerations are provided with regard to the regulatory environment for the clinical development of drugs for T1D, with a focus on the United States Food and Drug Administration and the European Medicines Agency. Future opportunities, such as combination treatments of immunomodulatory and beta-cell regenerating therapies, are also discussed.

Keywords: Type 1 diabetes, new drug development, regulatory environment, FDA, EMA, new mechanisms of action, insulins; anti-inflammatory drugs, immunomodulatory, islet regeneration.


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