2022 FDA TIDES (Peptides and Oligonucleotides) Harvest

Pharmaceuticals (Basel). 2023 Feb 22;16(3):336. doi: 10.3390/ph16030336.

Abstract

A total of 37 new drug entities were approved in 2022; although that year registered the lowest number of drug approvals since 2016, the TIDES class consolidated its presence with a total of five authorizations (four peptides and one oligonucleotide). Interestingly, 23 out of 37 drugs were first-in-class and thus received fast-track designation by the FDA in categories such as breakthrough therapy, priority review voucher, orphan drug, accelerated approval, and so on. Here, we analyze the TIDES approved in 2022 on the basis of their chemical structure, medical target, mode of action, administration route, and common adverse effects.

Keywords: FDA; drugs; gadopiclenol; lutetium (177Lu) vipivotide tetraxetan; oligonucleotides; peptides; terlipressin; tirzepatide; vutrisiran.