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news.Hyperion Therapeutics has reported that the first patient has been enrolled in a Phase II clinical trial of Ammonul or sodium phenylacetate and sodium benzoate injection 10%/10% in patients with grade III or IV hepatic encephalopathy.
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The randomized, double-blind study is designed to evaluate the safety and efficacy of Ammonul versus standard of care in hospitalized adults. The FDA has granted Ammonul orphan drug designation for the treatment of grade III and IV hepatic encephalopathy.