Tranzyme Pharma of Durham has won approval from the federal Food & Drug Administration to begin a Phase I safety and tolerability trial for its gastroparesis drug candidate.
Tranzyme develops small molecule drugs to treat gastrointestinal and metabolic diseases. Its gastroparesis drug candidate, TZP-102, is a second generation prokinetic drug. The company has another compound to treat post-operative ileus and severe gastroparesis undergoing Phase IIb trials.
"Advancing TZP-102 into clinical development further strengthens our product pipeline," Company President and CEO Vipin K. Garg, Ph.D., said. "Acceptance of this IND by the FDA represents a significant milestone for Tranzyme as well as for the technology underlying the discovery and development of this product. TZP-102 is the second clinical candidate to originate from our proprietary macrocyclic chemistry platform, MATCH."