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Fractyl Health, Inc.

Pipeline2 assets

  • RevitaDuodenal mucosa / Endoscopic hydrothermal ablation / Obesity
    Weight maintenance post-GLP-1 in obesityPivotalREMAIN-1 randomization completed; 6-mo topline expected early Q4 2026US
  • RejuvaRJVA-001 / Pancreatic beta cells / AAV9 gene therapy / Type 2 Diabetes
    Type 2 diabetesPhase 1/2CTA submitted; FIH dosing & preliminary data expected H2 2026 pending approvalEUAustralia

Latest news10 items

All news

Fractyl Health Reports Positive Randomized Data from REMAIN-1 Midpoint Cohort Demonstrating Durable Weight Maintenance One Year After GLP-1 Discontinuation

Up to 84% of GLP-1 induced weight loss retained with Revita® versus 46% with sham at one year in patients receiving complete duodenal ablations Next anticipated Revita® milestones are topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026 and a potential FDA De Novo

Trial ResultsREMAIN-1 Midpoint Cohort one-year results Wed, Jul 15, 2026, 8:00 AM ET

Fractyl Health Reports Positive One-Year REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® Procedure

Participants retained ~78% of GLP-1 induced total body weight loss one year after discontinuation and a single Revita procedure 5.3% mean weight change observed with Revita (n=15); published third-party studies after GLP-1 withdrawal alone have shown ~15% weight regain at similar time points 33% of

Trial ResultsREVEAL-1 one-year results Thu, Jun 4, 2026

Fractyl Health Reports First Quarter 2026 Financial Results and Business Updates

Next anticipated Revita ® clinical data readouts are 1-year data from the REVEAL-1 Cohort in Q2 2026 and 1-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 Early Q4 2026 timing for topline 6-month randomized data from the REMAIN-1 Pivotal Cohort and late Q4 2026 timing for

Trial Results • Phase 2/3REMAIN-1 Pivotal Cohort topline data Thu, Oct 1, 2026, 4:30 PM ET

Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes

Authorization advances Fractyl Health to a dual clinical-stage company, with Revita ® in pivotal development for post-GLP-1 weight maintenance and Rejuva ® entering first-in-human studies for type 2 diabetes First-in-human dosing and preliminary data expected in the second half of 2026, subject to

Trial Start • Phase 1/2
Fractyl Health, Inc. • Endpoint Arena