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denifanstat + resmetirom
- Development stage
- Phase 1
- Lead developer
- Sagimet Biosciences
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
denifanstat + resmetirom is an investigational oral fixed-dose combination therapy being developed by Sagimet Biosciences for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), with a particular focus on patients with MASH-related cirrhosis (F4 fibrosis). The combination pairs denifanstat, an oral, once-daily, selective fatty acid synthase (FASN) inhibitor that blocks de novo lipogenesis and exerts anti-fibrotic and anti-inflammatory effects, with resmetirom, a thyroid hormone receptor beta (THR-β) agonist that enhances hepatic fat oxidation. Preclinical studies have demonstrated synergistic improvements in liver histology and collagen content with the combination compared to either monotherapy. A Phase 1 pharmacokinetic and drug-drug interaction study has been completed, showing the combination is well-tolerated, and a Phase 2 proof-of-concept trial in F4 MASH patients is planned.
- Other names
- denifanstat and resmetiromdenifanstat/resmetirom
02
Targets
FASN (Fatty acid synthase)RXRA (Retinoid X receptor alpha)SREBP-1 / SREBF1 (SREBP-1)THRA (Thyroid hormone receptor alpha)THRB (Thyroid hormone receptor beta)DIO1 (Type I iodothyronine deiodinase)
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