Fractyl Health has received clinical trial application approval in the Netherlands to commence a first-in-human Phase I/II trial for RJVA-001, the first candidate from its Rejuva Smart GLP-1 gene therapy platform. RJVA-001 is designed as a one-time, pancreas-targeted therapy that uses an AAV vector to enable pancreatic beta cells to physiologically secrete GLP-1 in response to nutrient intake. The approach aims to provide durable glucose control and weight management with a single administration, potentially overcoming the adherence challenges associated with chronic, high-dose GLP-1 agonist injections.

The therapy is delivered via a minimally invasive endoscopic ultrasound-guided procedure directly into pancreatic tissue. Fractyl plans to dose the first patient during H2 2026 and release initial data shortly thereafter. If successful, RJVA-001 could represent a paradigm shift in the treatment of type 2 diabetes (T2D), moving from lifelong pharmacological intervention to a single-dose, regenerative gene therapy.

PharmCube's NextBiopharm® database shows that the only other GLP-1 gene therapy under active development is China-based Kanglin Bio's preclinical candidate. Click here to request a free trial for NextBiopharm®.