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

• Published in: Current diabetes reviews Vol. 13; no. 3; p. 300
• Main Authors: Mittermayer, Friedrich, Caveney, Erica, De Oliveira, Claudia, Fleming, G Alexander, Gourgiotis, Loukas, Puri, Mala, Tai, Li-Jung, Turner, J Rick
• Format: Journal Article
• Language: English
• Published: United Arab Emirates 01.01.2017
• Subjects: Animals; Diabetes Mellitus, Type 1 - drug therapy; Drug Discovery; Humans; Hypoglycemic Agents - pharmacology; Hypoglycemic Agents - therapeutic use; FDA; new mechanisms of action; Type 1 diabetes; regulatory environment; islet regeneration; EMA; new drug development; insulins; anti-inflammatory drugs; immunomodulatory
• ISSN: 1875-6417
• DOI: 10.2174/1573399812666160413115655

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.