The FDA has given the go-ahead for human clinical trials of the oral insulin formulation made by Generex Biotechnology. Called Oralgen in the United States, the liquid insulin is taken with Generex’s aerosol applicator.
Yet news from other clinical trials may be hard for people with diabetes to swallow. Generex says Oralgen “fell somewhere between” a placebo and injected insulin” when tested in other countries.
After analyzing the results of all trials performed so far, Bernard Zinman, MD, University of Toronto professor and director of the Banting and Best Diabetes Center, will develop Generex’s research plan for FDA approval.