A review of mitochondrial gene therapy summarized recent advances in treating mtDNA disorders and highlighted technical and regulatory challenges that remain. Authors cataloged delivery approaches, from allotopic expression to mitochondrial editing, and assessed preclinical successes alongside barriers in achieving durable, tissue‑specific correction of mitochondrial defects. The paper discussed vector design, intramitochondrial targeting, immune considerations and manufacturing constraints that slow clinical translation. It called for standardized outcome measures and coordinated regulatory pathways for rare mitochondrial indications. For investors and biotech teams, the review signals scientific momentum but also the need for platform innovations in targeting, scale‑up and safety de‑risking before large‑scale trials.