Theravance announced that the Food and Drug Administration (FDA) has granted Fast Track designation to to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.

Velusetrag, an oral, once-daily investigational medicine, is a highly selective agonist with high intrinsic activity at the human 5-hydroxtryptamine 4 (5-HT4) receptor. It is being developed internally by Theravance and is currently being studied in a large, multinational Phase 2b study in patients with confirmed gastroparesis of either diabetic or idiopathic origin

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The study is evaluating three doses of velusetrag (5, 15, and 30mg once daily for 12 weeks), with the primary endpoint being the effect of velusetrag on symptoms in patients with gastroparesis. In a completed Phase 2 study, velusetrag (in all 3 doses) was tied to a reduction in gastric emptying time (GE t1/2) compared to placebo.

Gastroparesis is characterized by delayed gastric emptying of food with symptoms of nausea, vomiting, early satiety, postprandial fullness, and upper abdominal pain. Two major sub-classes for this condition include: diabetic gastroparesis (29% of overall gastroparesis population) and idiopathic gastroparesis (36%).

“The valuable development and regulatory opportunities provided to the velusetrag program by Fast Track designation will augment our efforts to bring this important therapy to patients who currently have very few effective treatment options,” said Brett Haumann, MD, CMO at Theravance. “We look forward to results from our Phase 2b study in mid-2017.”

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