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Denifanstat

Alternative Names: Denifanstat, tvb-2640, tvb2640, tvb 2640, asc-40, asc40
Latest Update: 2025-01-06
Latest Update Note: News Article

Product Description

TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the _-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme. TVB-2640 is uncompetitive towards both NADPH and acetoacetyl-CoA in inhibiting KR activity. (Sourced from: https://clinicaltrials.gov/ct2/history/NCT02980029?V_2=View)

Mechanisms of Action: Fatty Acid Synthesis Inhibitor

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation:
Breakthrough Therapy - Non-alcoholic Steatohepatitis
Fast Track - Non-alcoholic Steatohepatitis *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: Ascletis
Company Location:
Company CEO:
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Denifanstat

Countries in Clinic: Canada, China, Hungary, Poland, Puerto Rico, United States

Active Clinical Trial Count: 15

Highest Development Phases

Phase 3: Acne Vulgaris|Fatty Liver, Alcoholic|Glioblastoma|Hepatitis, Alcoholic|Liver Cirrhosis|Liver Diseases, Alcoholic|Non-alcoholic Steatohepatitis

Phase 2: Non-Small-Cell Lung Cancer|Non-alcoholic Fatty Liver Disease

Phase 1: Healthy Volunteers|Liver Cirrhosis, Alcoholic|Prostate Cancer

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

FASCINATE-3

P3

Not yet recruiting

Hepatitis, Alcoholic|Fatty Liver, Alcoholic|Liver Cirrhosis|Non-alcoholic Steatohepatitis

2030-12-01

FASCINIT

P3

Not yet recruiting

Liver Diseases, Alcoholic|Hepatitis, Alcoholic|Fatty Liver, Alcoholic|Non-alcoholic Steatohepatitis

2026-06-01

NCT05743621

P1

Recruiting

Prostate Cancer

2025-11-01

ASC40-304

P3

Recruiting

Acne Vulgaris

2025-10-15

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