Consegna reformulates FDA approved drugs and creates new, long-acting injectable (LAI) medications with improved clinical and economic benefits. Our product pipeline focuses on therapeutic areas where LAIs offer high therapeutic and economic value, such as addressing high non-adherence, solving specific drug delivery challenges, or reducing side effects.
Using our computational drug delivery technology, we can design LAIs faster and better than legacy practice and with reduced regulatory and technical risk. We further reduce risk since we are starting with FDA approved drugs that have known safety, known efficacy, and known market success.
We use the accelerated FDA 505(b)(2) regulatory process that enables regulatory approvals 3X as fast at 1/3 the cost of new drug applications. In some cases we can use the generic ANDA process.