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
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.