FDA approvals for peptide and oligonucleotide drugs more than doubled in 2019
Background
Peptides and oligonucleotides, collectively known as TIDES, represent a growing class of therapeutic agents. Historically, drug development has focused heavily on small molecules and large biologics like antibodies. However, TIDES occupy a unique space, offering high specificity and potency often with fewer off-target effects. Despite a general decrease in the total number of drugs approved by the FDA in 2019 compared to 2018, the number of TIDES gaining approval significantly increased. This trend highlights their rising importance not just as standalone therapies, but also as imaging agents, theranostics, and key components of more complex drugs like antibody-drug conjugates. This review analyzes the newly approved TIDES to understand their chemical structures, mechanisms, and therapeutic roles, reflecting their firm establishment in modern medicine.
Study Design
This paper is a review and analysis of the therapeutic peptides and oligonucleotides (TIDES) that received U.S. Food and Drug Administration (FDA) approval in 2019. The authors examined the publicly available data for these newly authorized drugs. The analysis focused on several key characteristics for each approved compound: its specific chemical structure, its intended medical target (e.g., receptor or pathway), its pharmacological mode of action, and any reported adverse effects. The review compared the number of TIDES approvals in 2019 to the number from 2018 to contextualize the growth trend in this drug category.
Results
The analysis revealed a significant increase in the number of TIDES approved by the FDA in 2019. A total of seven TIDES were authorized, which is more than double the three that were approved in 2018. This increase occurred despite an overall drop in total new drug approvals by the FDA, which fell from 59 in 2018 to 48 in 2019. The approved TIDES spanned diverse medical indications and utilized various mechanisms of action. The paper highlights that these compounds are solidifying their place in therapy, not only as primary treatments but also in specialized roles such as imaging and theragnostics, and as parts of larger drug constructs.
The total number of TIDES authorized in 2019 increased to seven, a notable rise from the three approved in the previous year.
The findings underscore a clear trend: TIDES are becoming increasingly prevalent in the pharmaceutical arena. This consolidation paves the way for future approvals of other peptide and oligonucleotide drugs for a wide range of medical conditions.
Key Findings
- The FDA approved 7 new peptide and oligonucleotide (TIDES) drugs in 2019.
- This represents a significant increase from the 3 TIDES approved by the FDA in 2018.
- The rise in TIDES approvals occurred despite a decrease in total FDA drug approvals (48 in 2019 vs. 59 in 2018).
Why It Matters
This review confirms that peptide and oligonucleotide-based therapies are no longer a niche category but a rapidly expanding and integral part of the pharmaceutical pipeline. For clinicians and researchers, this signals a need to stay current with this class of drugs, which often have highly specific mechanisms and unique therapeutic profiles. The increasing number of approvals suggests that regulatory pathways are becoming more established for these complex molecules, potentially accelerating future development. This trend indicates a robust future for peptide-based medicine, with more sophisticated and targeted treatments for various diseases likely to emerge in the coming years. For biohackers and early adopters, this institutional validation may foreshadow greater availability and a wider range of compounds moving from research to clinical application, though it also underscores the importance of adhering to approved indications and safety profiles.
review
fda approval
peptides
oligonucleotides
drug development
pharmaceuticals
