2025 FDA TIDES (Peptides and Oligonucleotides) Harvest

Area of Science:

• Biotechnology
• Pharmacology
• Drug Development

Background:

• The FDA approved 46 novel drugs in 2025, including four TIDES (therapeutics, including peptides, oligonucleotides, and antibody drug conjugates).
• Three new oligonucleotide therapeutics (fitusiran, donidalorsen, plozasiran) were approved, bringing the total to 24 approved oligonucleotide drugs across 16 indications since 1998.
• Peptide therapeutics also advanced, with elamipretide approved as the first disease-specific treatment for Barth syndrome.

Purpose of the Study:

• To review TIDES approved in 2025.
• To emphasize their chemical structures, medical targets, and modes of action.
• To provide an overview of routes of administration and adverse effects.

Main Methods:

• Review of FDA-approved TIDES in 2025.
• Analysis of chemical structures, targets, mechanisms of action, administration routes, and adverse effects.
• Focus on oligonucleotide and peptide therapeutics.

Main Results:

• Three oligonucleotide therapeutics (fitusiran, donidalorsen, plozasiran) were approved, targeting antithrombin deficiency, hereditary angioedema, and familial chylomicronemia syndrome.
• These oligonucleotide therapies utilize GalNAc-mediated hepatocyte targeting, indicating the significance of liver-directed delivery.
• Elamipretide was approved for Barth syndrome, marking a significant advancement in peptide therapeutics.

Conclusions:

• The approval of new oligonucleotide and peptide therapeutics in 2025 underscores the growing clinical maturity and expanding applications of these drug classes.
• GalNAc-mediated delivery is a key platform for oligonucleotide drug development, particularly for liver-targeted therapies.
• Novel TIDES are providing disease-specific treatments for rare genetic disorders, expanding therapeutic options for patients.