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Jan 06, 2026

World’s First Clinical Trial of Mitochondrial Therapy by Pian Biotechnology

World’s First Clinical Trial of Mitochondrial Therapy by Pian Biotechnology

Pian Biotechnology has officially launched the world’s first clinical trial of a mitochondrial therapy, a major advancement in regenerative medicine. The therapy, PN-101, is engineered to restore mitochondrial function, improve cellular energy production, and potentially treat degenerative diseases and conditions associated with mitochondrial dysfunction.

Following promising preclinical results, PN-101 received regulatory approval to enter Phase 1 clinical trials. This study will focus on evaluating safety, tolerability, and early efficacy in a small patient cohort. Scientists believe that targeting mitochondrial dysfunction can address underlying causes of aging-related and chronic diseases, making PN-101 a potentially transformative therapy.

The CEO of Pian Biotechnology highlighted the historic nature of the trial: “Launching the first clinical trial for a mitochondrial therapy is a pivotal moment in medicine. We aim to deliver innovative treatments that can improve patient quality of life worldwide.”

The company plans to expand into later-phase trials to optimize dosing and explore broader therapeutic applications. PN-101 represents a first-in-class mitochondrial therapy, opening new frontiers in regenerative medicine. This clinical trial not only sets a global precedent but also demonstrates the growing potential of mitochondria-targeted therapies to revolutionize treatment for degenerative diseases.

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