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news.Tranzyme Pharma and Norgine have started dosing an intravenous ghrelin agonist, Ulimorelin in the first two patients of ULISES (ULImorelin Safety and Efficacy Study) Phase 3 trials.
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Tranzyme Pharma’s Ulimorelin is indicated for the management of postoperative ileus (POI) in hospital and acute care settings.
The companies are expecting to enroll about 300 bowel surgery patients across US and Europe.
The objective is to evaluate the efficacy and safety of two, once-daily, dosage regimens of Ulimorelin (160 and 480µg/kg) in accelerating gastrointestinal (GI) recovery in patients undergoing partial bowel resection.
Tranzyme Pharma president and CEO Vipin Garg said they are committed to finding new and safe therapeutics for critical, unmet medical needs, and the commencement of this Phase 3 program is a vital step towards achieving that goal.