> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Tells Tetraphase It Needs Another Trial for NDA
- URL: https://www.fdaweb.com/fda-tells-tetraphase-it-needs-another-trial-for-nda/
- Published: 2016-05-13T12:00:00.000Z
- Updated: 2026-09-14T21:02:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5135665

FDA has told Tetraphase Pharmaceuticals that it will need positive data from an additional Phase 3 trial for its lead candidate, eravacycline, in order to support an NDA for the antibiotic. The drug has shown potent activity against drug-resistant bacteria, including multidrug-resistant pathogens, the company says.

Based on the feedback, Tetraphase says it plans to conduct a pivotal Phase 3 clinical trial to evaluate the efficacy and safety of twice-daily intravenous eravacycline in patients with complicated intra-abdominal infections. It says the study should begin in the fourth quarter, and top-line results could be available as early as the fourth quarter of 2017\. In addition, Tetraphase also plans to conduct a Phase 3 clinical trial evaluating eravacycline’s efficacy and safety in patients with complicated urinary tract infections.