Tranzyme has received FDA Fast Track status for the company’s oral gastrointestinal (GI) prokinetic drug candidate TZP-102. It is intended for the treatment of gastroparesis in diabetic patients.
Tranzyme is currently enrolling patients in a multi-national phase 2, randomized, double-blind, placebo-controlled study of TZP-102.
Reportedly, the outcomes will evaluate the safety and efficacy of TZP-102 in accelerating gastric emptying and improving symptoms of gastroparesis in diabetic patients.
Gordana Kosutic, vice president of Clinical and Regulatory Affairs at Tranzyme, said: “We are extremely pleased that TZP-102 has received the FDA’s designation as a Fast Track product. 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.”