Oligonucleotide-Based Drug Development: Considerations for Clinical Pharmacology and Immunogenicity.

Journal Article (Journal Article)

The field of oligonucleotide (OGN)-based therapeutics has been growing dramatically in the past decade, providing innovative platforms to develop agents for the treatment of a wide variety of clinical conditions. OGN agents have unique physicochemical properties and pharmacokinetic/pharmacodynamic characteristics. This review considers findings from the literature and information on new molecular entities submitted to the US Food and Drug Administration as OGN-based therapeutics. In addition, the article discusses several challenging issues from the perspective of clinical pharmacology, emphasizing the potential of immunogenicity, the effect of renal impairment on OGN exposure, drug-drug interactions, and the utility of pharmacokinetic/pharmacodynamic modeling. The field of OGN-based therapeutics is in evolution and will benefit from further studies as well as clinical experience to formulate guidelines and promote the development of this class of agents.

Full Text

Duke Authors

Cited Authors

  • Wang, J; Lon, H-K; Lee, S-L; Burckart, GJ; Pisetsky, DS

Published Date

  • November 2015

Published In

Volume / Issue

  • 49 / 6

Start / End Page

  • 861 - 868

PubMed ID

  • 30222372

Electronic International Standard Serial Number (EISSN)

  • 2168-4804

Digital Object Identifier (DOI)

  • 10.1177/2168479015592195


  • eng

Conference Location

  • Switzerland