The company expects to recruit around 1700 patients to evaluate the effectiveness of NB-001 at 72 clinical sites.
The patient recruitment will be completed in 2012.
NanoBio Clinical Research vice president Mary Flack said based on the efficacy of NB-001 in Phase 2, they are very optimistic about these trials and the path to FDA approval.
"The initiation of these trials marks a significant step towards the commercialization of a new treatment offering for cold sores, as well as potential other new offerings to come from our nanoemulsion-based platform technology," Flack said.