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# FDA Wants Another Trial for Motif Bio’s Iclaprim
- URL: https://www.fdaweb.com/fda-wants-another-trial-for-motif-bios-iclaprim/
- Published: 2019-06-06T12:00:00.000Z
- Updated: 2026-09-15T01:31:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144281

Motif Bio says FDA is requiring an additional clinical trial before it can approve the company’s NDA for iclaprim, indicated for treating acute bacterial skin and skin structure infections. The agency expressed its position at a recent Type A meeting about a [complete response letter](https://www.fdaweb.com/complete-response-for-motif-bio-nda/) that was issued in February. FDA said that the trial needs to further evaluate the risk for liver toxicity. The submission was based on data from REVIVE Phase 3 trials in patients who had wound infections, and showed that iclaprim was non-inferior to vancomycin in a pooled analysis of a subgroup of patients. The company says that iclaprim and vancomycin had similar adverse event profiles in patients with wound infections.