RJV001 is being developed as an injectable biologic to reduce submental fat, thus providing a non-invasive alternative for patients troubled by the problem. Once approved, RJV001 may surpass the conventional liposuction surgeries to minimize surgical trauma, reduce medical cost and shorten recovery. RJV001 is expected to fulfill all required tests and an Investigative Drug Application for Clinical Studies (IND) will be submitted to the Food and Drug Administration (FDA) of the United States in the first half of 2019. Clinical Phase I study is expected to commence in later 2019.
Currently, the following preclinical studies have been or nearly completed:
- CMC -
- Product Validation -
- Efficacy Studies -
- Safety Evaluation -