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Denifanstat (Denifanstat) | Accelerate Your Fibrosis Research

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Denifanstat

Denifanstat

Phase 3

Sponsor: Sagimet Biosciences

Indication: MASH

Mechanism of Action

FASN Inhibitor

Target: FASN

Clinical Information

Approval Year

Clinical Trials (ClinicalTrials.gov)

COMPLETEDNCT06192264

A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris

Phase:PHASE3Org:Ascletis Pharma Inc

ACTIVE_NOT_RECRUITING

Relevant Publications (PubMed)

Denifanstat for moderate-to-severe acne: A Phase 2, randomized, double-blind, placebo-controlled trial.

Chen Q, Chen R, Wu L et al.

J Eur Acad Dermatol Venereol2025 Nov 4

Fatty acid synthase in chemoresistance: mechanisms and therapeutic opportunities.

Huang L, Zhang M, Xiao Y

Front Pharmacol2025

Present and Future Perspectives in the Treatment of Liver Fibrosis.

Cerrito L, Galasso L, Iaccarino J et al.

Pharmaceuticals (Basel)2025 Sep 3

Targeting cancer metabolism: Therapeutic potential of the fatty acid synthase (FASN) inhibitors.

Validated Models

This drug has been validated in the following preclinical models:

NCT07216313

A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult Participants

Phase:PHASE1Org:Sagimet Biosciences Inc.

ACTIVE_NOT_RECRUITINGNCT03179904

TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer

Phase:PHASE2Org:Mayo Clinic

WITHDRAWNNCT06692283

A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH

Phase:PHASE3Org:Sagimet Biosciences Inc.

COMPLETEDNCT05835180

A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function

Phase:PHASE1Org:Sagimet Biosciences Inc.

View all trials on ClinicalTrials.gov

Nuzzo PV, Rodrigues S, Ribeiro CF et al.

Crit Rev Oncol Hematol2025 Oct

Fatty acid synthase (FASN) inhibition cooperates with BH3 mimetic drugs to overcome resistance to mitochondrial apoptosis in pancreatic cancer.

Steen TV, Espinoza I, Duran C et al.

Neoplasia2025 Apr

View more on PubMed