D-Pharm Ltd., a Challenge Fund II Portfolio Company, has obtained US Food and Drug Administration (FDA) approval for the company's protocol for its Phase III clinical trial of DP-b99, a treatment for strokes. The trial will include 750 patients.

If the trial shows significant results with regard to safety and efficacy, the FDA will recognize the test results as "first pivotal trial". D-Pharm will, however, still have to carry out a number of preclinical and clinical trials for the registration procedure of the drug, some of which are before the company files its Investigational New Drug (IND) application with the FDA and the start of the Phase III trial.