Preclinical Drug Development Testing for Oligonucleotide Drugs

Since the first siRNA drug was approved in 2018, oligonucleotide therapeutics have increased as an emerging drug modality. Oligonucleotides are short single or double-stranded fragments of DNA or RNA molecules that have a wide range of potential applications. However, due to its novelty and complexity, oligonucleotides have more technical challenges and unknown consequences for drug developers compared to many more conventional drugs. As such, oligonucleotides require pharmacokinetic evaluation systems that differ from traditional testing methods. WuXi AppTec’s Drug Metabolism and Pharmacokinetics (DMPK) Service Department’s extensive experience with oligonucleotide studies – combined with guidelines issued by various drug regulatory authorities on oligonucleotide development and studies in frontier literatures has enabled us to build a set of ADME evaluation systems for oligonucleotides that significantly shorten development cycles.