Asset profile
Denifanstat
Small molecule
Evidence outlook · lead readout
FASCINATE-2 (NCT04906421) · Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.
FASCINATE-2 (NCT04906421): The study randomized 168 participants in a 2:1 ratio and was double-blind with a placebo comparator. Both primary histological endpoints were met: NAS improvement occurred in 42/112 participants receiving TVB-2640 versus 9/56 receiving placebo (two-sided p=0.0035), while steatohepatitis resolution occurred in 29/112 versus 6/56 (two-sided p=0.0173).
Also in development:Metabolic Dysfunction-Associated Steatohepatitis · Phase 2
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
37 competitors in this universe: 0 direct rivals (same mechanism and indication), 1 same-class, 36 same-indication; 3 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Denifanstat: this drug | Phase 3 | Small molecule | FASN, Fatty acid synthase (FASN) | ||
| CMS121 | Phase 1 | Small molecule | Fatty acid synthase (FASN), Fatty acid synthase (FASN) | ||
| Resmetirom (Rezdiffra) | Approved | Small molecule | Thyroid hormone receptor-beta | ||
| Rosuvastatin | Approved | Small molecule | HMG-CoA reductase | ||
| Semaglutide (Wegovy / Ozempic / Rybelsus) | Approved | Peptide | GLP-1 receptor | ||
| ALN-CIDEB | Phase 3 | RNA / oligonucleotide | CIDEB | ||
| Aramchol | Phase 3 | — | Stearoyl-CoA desaturase 1 (SCD1) | ||
| Efimosfermin | Phase 3 | Protein / enzyme therapeutic | FGF21 | ||
| Efimosfermin Alfa | Phase 3 | Protein / enzyme therapeutic | FGF21 receptor | ||
| Lanifibranor | Phase 3 | Small molecule | Peroxisome proliferator-activated receptors (PPARs), PPAR (pan-agonist) | ||
| Lobeglitazone (Duvie) | Phase 3 | Small molecule | PPAR-gamma | ||
| Namodenoson | Phase 3 | — | Adenosine A3 receptor | ||
| ORMD-0801 | Phase 3 | Peptide | Insulin receptor (basal) | ||
| Pemvidutide | Phase 3 | Peptide | GLP-1/glucagon receptor (dual) | ||
| Survodutide | Phase 3 | Peptide | GLP-1/glucagon receptor (dual) | ||
| Belapectin | Phase 2/3 | Protein / enzyme therapeutic | Galectin-3 |
…and 22 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Upcoming events
(1 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (1)
January 2027 (1)
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.