2025 FDA TIDES (peptides and oligonucleotides) Harvest
File(s)
Published version
Author(s)
AlShaer, Danah
Al Musaimi, Othman
Albericio, Fernando
de la Torre, Beatriz G
Type
Journal Article
Abstract
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 delivery platforms in oligonucleotide drug development and underscoring the growing clinical maturity of this therapeutic class. Peptide-based therapeutics continue to emerge as pioneering treatments for longstanding diseases. In 2025, elamipretide further expanded this paradigm by becoming the first disease-specific treatment approved for Barth syndrome. This review provides an overview of TIDES approved in 2025, with emphasis on their chemical structures, medical targets, modes of action, routes of administration, and associated adverse effects.
Date Issued
2026-01-30
Date Acceptance
2026-01-28
Citation
Pharmaceuticals, 2026, 19 (2)
ISSN
1424-8247
Publisher
MDPI AG
Journal / Book Title
Pharmaceuticals
Volume
19
Issue
2
Copyright Statement
© 2026 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license
License URL
Publication Status
Published
Date Publish Online
2026-01-30