Fractyl Health, Inc.GUTS
Metabolic9 cited findings · profile updated 2026-08-25
0.76 USDnot live — refreshed daily
About Fractyl Health, Inc.
Fractyl Health, Inc. (GUTS) is focused on metabolic therapeutic areas. The company is developing Revita, which has been studied for its ability to maintain GLP-1-induced weight loss. In the REMAIN-1 Midpoint Cohort, 84% of participants maintained GLP-1-induced weight loss with Revita, compared to 46% in the sham arm. The REVEAL-1 Cohort, comprising 15 participants, showed 78% of GLP-1-induced weight loss maintained with Revita, with a mean total body weight change of 5.3% after GLP-1 discontinuation. Fractyl Health, Inc. anticipates a potential U.S. Food and Drug Administration (FDA) De Novo marketing application submission for Revita in late Q4 2026.
Compiled from the cited findings below — figures are as stated in each company's published technical reports and filings.
Key figures — cited
| GLP-1-induced weight loss maintained | 84 % (Revita, REMAIN-1 Midpoint Cohort) vs 46 % (Revita, REMAIN-1 Midpoint Cohort, sham arm) | FRACTYL HEALTH, INC. — SEC 8-K (2026-08-10), p.1 |
| GLP-1-induced weight loss maintained | 78 % (Revita, REVEAL-1 Cohort) | FRACTYL HEALTH, INC. — SEC 8-K (2026-08-10), p.1 |
| mean total body weight change after GLP-1 discontinuation | 5.3 % (Revita, REVEAL-1 Cohort) | FRACTYL HEALTH, INC. — SEC 8-K (2026-08-10), p.2 |
| FDA De Novo submission | late Q4 2026 (Revita) | FRACTYL HEALTH, INC. — SEC 8-K (2026-08-10), p.1 |
Key projects
- Revita — United States
A potential U.S. Food and Drug Administration (FDA) De Novo marketing application submission for Revita is anticipated in late Q4 2026.
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