Journal
TOXICOLOGIC PATHOLOGY
Volume 43, Issue 1, Pages 48-56Publisher
SAGE PUBLICATIONS INC
DOI: 10.1177/0192623314557179
Keywords
SGLT2 inhibitor; canagliflozin; rat carcinogenicity; pheochromocytomas; renal tubular tumors; Leydig cell tumors; carbohydrate malabsorption
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Funding
- Janssen Research & Development, LLC
- Janssen Global Services, LLC
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Canagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, has been developed for the treatment of adults with type 2 diabetes mellitus (T2DM). During the phase 3 program, treatment-related pheochromocytomas, renal tubular tumors, and testicular Leydig cell tumors were reported in the 2-year rat toxicology study. Treatment-related tumors were not seen in the 2-year mouse study. A cross-functional, mechanism-based approach was undertaken to determine whether the mechanisms responsible for tumorigenesis in the rat were of relevance to humans. Based on findings from nonclinical and clinical studies, the treatment-related tumors observed in rats were not deemed to be of clinical relevance. Here, we describe the scientific and regulatory journey from learning of the 2-year rat study findings to the approval of canagliflozin for the treatment of T2DM.
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