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news.Addrenex Pharmaceuticals has announced that the FDA has approved its investigational new drug application for ADX415, a novel hypertension drug. With the approval, Addrenex has launched a Phase II clinical trial to study ADX415 as a targeted therapy for hypertension.
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The Phase II trial is a multicenter, double-blind, placebo-controlled, dose-ranging study that will involve 80 patients. ADX415 is a novel, patented, centrally acting, alpha-adrenergic receptor agonist specific to alpha-2 receptors.
The company’s first two drug candidates are Clonicel to treat attention deficit hyperactivity disorder and CloniBID to treat hypertension. Clonicel is currently in Phase III trials, and a new drug application has been filed for CloniBID with FDA review expected by the end of 2008. Commercial rights to both drugs, and to ADX415, have been granted to Atlanta-based Sciele Pharma, a Shionogi company.
ADX415 is the company’s third drug to receive investigational new drug approval and enter human trials in a two-year period, said Addrenex.
Moise Khayrallah, co-founder and CEO of Addrenex, said: “We built our company to address a wide range of conditions whose symptoms are not fully managed by drugs currently on the market. Our scientific team continues to identify and analyze alpha-2 compounds that could potentially address the unmet needs of patients across a wide range of conditions.”