Most of the products developed by Bioprojet are “First in Class”, in other words, they are the leaders in a new class of drugs. These include Racecadotril, an enkephalinase inhibitor, and Pitolisant, antagonist/inverse agonist of histamine H3 presynaptic receptors, or BP1.4979, a partial agonist of the dopamine D3 receptor.
These products are new chemical entities, and most of them have original mechanisms of action. Obtaining a marketing authorisation (MA) entails completing a comprehensive pharmaceutical, preclinical and clinical development process.
The Clinical Development Department in Paris takes charge of the drug candidates from the Bioprojet Biotech research centre to conduct the pharmaceutical development and therapeutic trials in humans from phase I to phase III and to obtain product regulatory registration in the selected indications.