Clinical TrialMay 11, 2026, 07:06 AM
Fractyl Health Authorized for First-in-Human Trial of RJVA-001 in Netherlands
AI Summary
Fractyl Health, Inc. announced it has received Clinical Trial Application authorization in the Netherlands to initiate the Phase 1/2 first-in-human study of RJVA-001, the lead candidate from its Rejuva Smart GLP-1 gene therapy platform. This authorization makes Fractyl Health a dual clinical-stage company, with Revita in pivotal development and Rejuva entering clinical studies for Type 2 Diabetes. The company expects to dose the first patient and report preliminary data in the second half of 2026, with Rejuva's clinical development funded 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 clinical candidate from the Rejuva Smart GLP-1 gene therapy platform.
- Phase 1/2 first-in-human study will evaluate safety, tolerability, and preliminary efficacy in T2D.
- First patient dosing and preliminary data for RJVA-001 are expected in the second half of 2026.
- Rejuva clinical development is funded within existing cash runway into early 2027.
- The study involves three escalating dose cohorts of 3 participants each, plus an optional expansion cohort of up to 20.
- Participants will be monitored for 12 months, with long-term follow-up for up to 5 years.
Price Impact
More from GUTS