Research & Development
US FDA approves Oramed Pharmaceuticals' Investigational New Drug application for human trials of ORMD-0901
18 September 2018 -

The United States Food and Drug Administration (FDA) has approved Israel-based Oramed Pharmaceuticals Inc's (NASDAQ :ORMP)(TASE: ORMP) Investigational New Drug application (IND) for human trials of its oral GLP-1 analogue capsule ORMD-0901, it was reported yesterday.

The product is utilised in the treatment of type 2 diabetes and presently only offered through injection. In a prior Phase one study on type two diabetic patients, the company's ORMD-0901 capsule was well tolerated and indicated encouraging efficacy, including decreasing blood sugar levels following a standard meal as compared to a placebo.

The company's planned Phase one pharmacokinetic study is a fully-randomised, single-blind, placebo-controlled four-way crossover study that will assess safety in addition to the pharmacokinetics of ORMD-0901 compared to placebo and to open label Byetta, a GLP-1 analogue presently on the market, in up to 15 healthy subjects.

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