Clinical TrialMay 11, 2026, 07:03 AM
Fractyl Health gets EU authorization for RJVA-001 gene therapy study
AI Summary
Fractyl Health, Inc. announced it has received Clinical Trial Application authorization in the Netherlands to initiate a Phase 1/2 first-in-human study for RJVA-001, its lead candidate from the Rejuva® Smart GLP-1™ gene therapy platform. This authorization makes Fractyl Health a dual clinical-stage company, with RJVA-001 being the first adeno-associated virus (AAV)-based gene therapy candidate to enter clinical development for type 2 diabetes. The company expects to dose the first patient and report preliminary data in the second half of 2026, with funding for Rejuva's clinical development secured within its existing cash runway into early 2027.
Key Highlights
- Fractyl Health received Clinical Trial Application authorization in the Netherlands for RJVA-001.
- RJVA-001 is the first AAV-based gene therapy candidate to enter clinical development for type 2 diabetes.
- The company is now a dual clinical-stage company with Revita® and Rejuva®.
- First-in-human dosing and preliminary data for RJVA-001 are expected in H2 2026.
- RJVA-001 is a one-time, beta-cell-targeted gene therapy for nutrient-responsive GLP-1 expression.
- Rejuva® clinical development is funded within existing cash runway into early 2027.
- The Phase 1/2 study will evaluate safety, tolerability, and preliminary efficacy in adults with inadequately controlled T2D.
- Fractyl also plans to conduct the study in Australia, with regulatory feedback expected in Q3 2026.
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