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news.Tranzyme Pharma's first product candidate to enter clinical development, TZP-101, which is being developed for post-operative ileus and other gastrointestinal motility disorders, has been shown to be safe and well tolerated in a phase I trial.
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TZP-101 is a selective ghrelin receptor agonist with potent gastroprokinetic properties that represents the first in its class to enter into a clinical trial.
The trial was an ascending dose, placebo-controlled study in which 48 healthy volunteers were randomly assigned to receive one of six TZP-101 dose levels or placebo as a 30-minute intravenous infusion.
“These data demonstrate that the tolerability, safety and a highly attractive pharmacokinetic profile of TZP-101 support continuing clinical development,” said Dr Gordana Kosutic, vice president of clinical and regulatory affairs for Tranzyme.
Dr Kosutic went on to say that the company would now go on to evaluate the drug in a single dose study in type 1 diabetic patients experiencing delayed gastric emptying.
Tranzyme is developing its ghrelin agonists both as an intravenous therapy (TZP-101) for acute, hospital-based applications and as an orally administered product (TZP-102) for chronic GI disorders.