Current Status of Oligonucleotide Therapeutics in the Market and Clinical Development

Moumné and coworkers searched GlobalData, Clinicaltrials.gov (accessed on 20 November 2021), and PubMed for relevant information on oligonucleotide therapeutics targeting gene expression through direct interaction with RNA or DNA, with a focus on compounds that have hit the market or are in advanced stages of clinical development (phases II and III). They identified 93 compounds, and among these oligonucleotide therapeutics, 13 obtained approval between 1998 and 2021. One hundred and thirty phase II or phase III clinical trials are currently underway involving 80 oligonucleotide therapeutics that have been approved or tested in 102 different indications across 14 therapeutic areas. These oligonucleotide therapeutics target 66 different genes. The specific statistical analysis data of oligonucleotide therapeutics in the market and clinical development are listed below^[1].

• According to figure a, ASO is the most representative of oligonucleotides.
• Regarding the mode of action, among the 93 oligonucleotides, expression inhibitors (such as ASO or siRNA) represent 85% of the molecules (79 out of 93) and expression activators (like splicing modulating ASOs, mir mimics, or saRNAs) represent 15% (Figure b).
• Oligonucleotides can target all organs in the human body, and the liver is the most represented tissue and is targeted by 46% of oligonucleotides (Figure c).
• The majority of oligonucleotides are administered systemically (two thirds), mainly by a subcutaneous or intravenous route, and a significant proportion of oligonucleotides are injected topically (one third) (Figure d).
• Given the wide variety of tissues that can be targeted, oligonucleotide-based therapies can potentially be applied to all therapeutic areas and for many indications (Figure e).

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