Despite progress, miRNA therapeutics faces several challenges that need to be addressed for clinical success. 

1.  Delivery Challenges 

     ●      Effective delivery to target tissues or cells without degradation remains a major hurdle. 

     ●      The lack of non-toxic and efficient delivery vehicles limits widespread clinical application. 

2.  Off-Target Effects 

     ●      miRNAs regulate multiple genes and pathways. Altering their expression may cause unintended effects on non-target genes, leading to toxicity or adverse outcomes. 

3.  Safety Concerns 

     ●      Synthetic miRNA molecules and delivery carriers can trigger immune responses or inflammation, posing challenges for long-term safety. 

4.  Complex Biological Roles 

     ●      The functions of miRNAs can vary depending on the disease context, making therapeutic design and validation more difficult. 

5.  Regulatory and Economic Barriers 

     ●      Demonstrating long-term safety, efficacy, and consistent manufacturing processes is challenging under current regulatory frameworks. 

     ●      The high cost of development and scaling production can limit commercial viability. 

While miRNA therapeutics offer significant promise, challenges such as delivery efficiency, off-target effects, and regulatory hurdles remain obstacles to clinical success. Continued innovations in nanotechnology, precision medicine, and delivery systems will be critical for overcoming these barriers and fully unlocking the potential of miRNA-based treatments.