Tranzyme GI Candidate Gets Fast Tracked

Tranzyme Pharma’s oral gastrointestinal (GI) prokinetic drug candidate TZP-102, for the treatment of gastroparesis in diabetic patients, was granted Fast Track designation from the FDA. Gastroparesis is a serious complication of diabetes mellitus that affects approximately 30-60% of diabetic patients.

Fast track designation is designed to facilitate the development and expedite the review of a drug candidate that treats a serious or life-threatening condition and addresses an unmet medical need. Tranzyme is currently enrolling patients in a multi-national Phase II, randomized, double-blind, placebo-controlled study of TZP-102. The trial will evaluate the safety and efficacy of TZP-102 in accelerating gastric emptying and improving symptoms of gastroparesis in diabetic patients.

“We are extremely pleased that TZP-102 has received the FDA’s designation as a Fast Track product,” said Gordana Kosutic, M.D., Tranzyme’s vice president of Clinical and Regulatory Affairs. “We routinely hear from patients suffering from gastroparesis who are excited about the progress of our clinical programs and hopeful that a safe and effective therapy is forthcoming. Being granted Fast Track status is another milestone in helping to meet that need.”

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