Diazoxide Choline Controlled Release

Diazoxide choline controlled release is a novel, crystalline patent-protected salt of diazoxide in a controlled release once-per-day tablet.

Diazoxide free base is approved as a t.i.d oral suspension (proglycem) that has been used safely for decades in tens of thousands of patients.

Essentialis is pursuing a 505(b)(2) registration process for Diazoxide Choline Controlled Release.

Essentialis has filed multiple patent applications covering the product and its uses. The patent applications provide composition of matter protection on the product.

Essentialis has assembled an extensive toxicological package on the product which shows a wide-margin of safety for therapeutically relevant doses.

The ompany has completed 4 clinical trials with diazoxide choline controlled release, which have included more than 100 subjects treated with the drug for periods ranging from 1 day to 7 weeks. The ongoing Phase II trial is described on the clinical trial page.

Back-ups

Essentialis has identified and fully characterized other patent-protected salts of diazoxide that would be available for use in other indications and uses.