Innorna has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IN026, an investigational mRNA-based therapy for refractory gout.
The IND clearance enables the company to initiate a phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of IN026 in this currently underserved patient population.
IN026 delivers mRNA encoding urate oxidase (uricase; UOX) to the liver to enable systemic uric acid breakdown.
Refractory or difficult‑to‑treat gout refers to patients who continue to experience frequent flares, progressive tophi, or cannot achieve target serum urate despite guideline‑directed urate‑lowering therapy, representing a population with substantial unmet medical need. In 2026, refractory gout is estimated to affect approximately 1.9m people worldwide, representing about 3% of all gout patients.
“Refractory gout remains a severely debilitating condition, and existing biologic treatments are limited by immunogenicity, tolerability challenges, and diminishing efficacy over time. We are proud to advance IN026 into clinical development as a potential first-in-class investigational mRNA therapeutic designed to overcome these limitations,” said Michael Beckert, chief medical officer of Innorna.
“We founded Innorna on the conviction that mRNA, as a new modality, can achieve what existing therapeutic approaches cannot,” said Linxian Li, founder and CEO of Innorna.
“With IN026 advancing into clinical development, we are pioneering a new chapter for mRNA-based protein-replacement therapies engineered for repeated administration and long-term control of chronic diseases.”