2025 FDA TIDES (Peptides and Oligonucleotides) Harvest

In 2025, the FDA approved 46 novel drugs, including four TIDEs (one peptide, three oligonucleotides, and one antibody drug conjugate containing peptide as a payload). The three approved oligonucleotide therapeutics-fitusiran, donidalorsen, and plozasiran-bring the total number of approved oligonucleotide drugs to 24 across 16 clinical indications since 1998. Fitusiran and donidalorsen are the first oligonucleotide therapies approved for antithrombin deficiency and hereditary angioedema, respectively, while plozasiran represents the second approved therapy for familial chylomicronemia syndrome. All three agents employ GalNAc-mediated hepatocyte targeting, highlighting the continued importance of liver-directed…

• NR
  National Research Foundation
• IY
  Inyuvesi Yakwazulu-Natali