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The Development And Evaluation Of Januvia Essay

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The development and evaluation of Januvia® (Sitagliptin Phosphate) are illustrative of the activities that are needed to assess the efficacy, safety and effectiveness of a new product for treating type 2 diabetes milieus. It is the first drug of dipeptidyl peptidase-4 (DPP-4) inhibitors class that is approved as an adjunct to diet and exercise to improve the glycemic control.1 Januvia was developed by Merck Research Laboratories and received the FDA approval on 16 October 2006.2 Preclinical/Animal study: The animal study of MK-0431, the code name for Sitagliptin in early development phase, was done in mice, rat, and dog. Maximum recommended daily adult human dose (MRHD) of Sitagliptin was found 100mg/day and NOAEL 50mg/kg based on dog study.3 Two years of carcinogenic study was conducted on mice and rat. In rat, liver adenoma/carcinoma has been seen at 60 times of MHRD. This is probably due to chronic hepatotoxicity of the drug. No tumor incidence was observed in case of mice up to 70 times of MHRD. Both in vitro assay and in vivo mice assay was not suggestive of mutagenic and clastogenic nature of MK-0431. Fertility adverse effect was also not at 12 times of MHRD)3 and Sitagliptin was labeled as pregnancy category B.4 Based on these preclinical studies on animal, Merck submitted their Investigational New Drug (IND 65, 495) application to FDA was on August 2002.4 Phase I: Phase I of Sitagliptin study was done on 33 volunteer humans. Following 100mg of Sitagliptin oral
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