FDA Clears IND Application of Tranzyme's Gastric Drug
Posted on: Friday, 1 February 2008, 12:00 CST
The FDA has accepted Tranzyme Pharma's investigational new drug application for TZP-102 for the treatment of gastroparesis.
TZP-102 is a second generation prokinetic drug that Tranzyme intends to develop for the treatment of mild-to-moderate gastroparesis and other chronic gastrointestinal motility disorders. A Phase I safety and tolerability trial of TZP-102 will begin immediately.
Vipin Garg, president and CEO of Tranzyme, said: "Advancing TZP-102 into clinical development further strengthens our product pipeline. 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."
Source: Datamonitor
Related Articles
- Tranzyme Pharma Announces Positive Phase IIb Results With Its Ghrelin Agonist, TZP-101, for Postoperative Ileus (POI)
- Tranzyme Pharma Announces Successful Thorough QT/QTc Study of Ghrelin Agonist TZP-101
- Tranzyme Pharma's Ghrelin Agonist TZP-102 Demonstrates Safety and High Oral Bioavailability in the Successful Completion of a Phase I Trial
- Tranzyme Pharma Initiates Dosing in Humans With Second Drug Candidate TZP-102
- Tranzyme Pharma Receives IND Clearance for Its Oral Ghrelin Agonist, TZP-102, for the Treatment of Gastroparesis
- Tranzyme Pharma Initiates Dosing of Patients in a Multi-National Phase IIb Clinical Trial With Its Novel Ghrelin Agonist, TZP-101, for Post-Operative Ileus
- Tranzyme Pharma Presents Initial Phase IIa Data for Its Novel Ghrelin Agonist, TZP-101, in Patients With Diabetic Gastroparesis
- Tranzyme Pharma Expands Clinical Program of Its Novel Ghrelin Agonist, TZP-101, to Include Patients With Gastroparesis
- Tranzyme Pharma Announces Successful Completion of Phase I Clinical Trial of Its Novel Ghrelin Agonist, TZP-101
- Tranzyme Pharma Presents Positive Preclinical Efficacy Data for Its Lead GI Therapeutic, TZP-101; Data Presented at Digestive Disease Week 2005
User Comments (0)
RSS Feeds