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# Cellceutix Submits Protocol to FDA on Novel Antibiotic
- URL: https://www.fdaweb.com/cellceutix-submits-protocol-to-fda-on-novel-antibiotic/
- Published: 2016-02-26T12:00:00.000Z
- Updated: 2026-09-15T02:39:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134894

Cellceutix Corp. has submitted a Special Protocol Assessment request and a final protocol to FDA for a Phase 3 clinical trial of its antibiotic, Brilacidin, for treating acute bacterial skin and skin structure infection (ABSSSI) caused by Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus. The company says it met with FDA for an end-of-Phase 2 meeting last July and is now submitting a protocol to evaluate the efficacy and safety of single-dose IV Brilacidin vs. IV vancomycin followed by optional PO linezolid to treat patients with ABSSSI. Brilacidin is in a new class of antibiotics, the HDP mimics, according to the company, and has an advantage of an intermediate half-life vs. other single-dose ABSSSI regimens with very long half-lives, which can remain in the body for weeks at low levels and may further promote the development of resistance.  
  
Cellceutix says Brilacidin also has activity against stationary phase bacteria, which play a role in persistent infections and biofilm formation and has anti-inflammatory properties that may accelerate and promote clinical healing.