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 SteatohepatitisFast Track - Non-alcoholic Steatohepatitis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Sagimet
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Canada, China, Hungary, Poland, Puerto Rico, United States
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Sagimet announced they will present P1 Liver Cirrhosis, Alcoholic results in 1H26 for Denifanstat
- Clinical Outcomes Reported - Sagimet presented P2 Non-alcoholic Steatohepatitis results on 2025-11-10 for Denifanstat
- Clinical Outcomes Reported - Sagimet presented P3 Acne Vulgaris results on 2025-10-25 for Denifanstat
Highest Development Phases
Phase 3: Acne Vulgaris|Glioblastoma
Phase 2: Fatty Liver, Alcoholic|Hepatitis, Alcoholic|Liver Diseases, Alcoholic|Non-Small-Cell Lung Cancer|Non-alcoholic Steatohepatitis
Phase 1: Healthy Volunteers|Liver Cirrhosis, Alcoholic|Prostate Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03808558 |
STU 022017-058 | P2 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2025-04-03 |
12% |
2025-05-16 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT05835180 |
SB2640-CLIN-009 | P1 |
Completed |
Liver Diseases, Alcoholic|Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis|Liver Cirrhosis, Alcoholic|Fatty Liver, Alcoholic |
2023-12-18 |
23% |
2023-12-27 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT06248008 |
ASC40-304 | P3 |
Active, not recruiting |
Acne Vulgaris |
2025-10-15 |
11% |
2025-03-13 |
Primary Endpoints|Treatments|Trial Status |
NCT05118776 |
ASC40-301 | P3 |
Active, not recruiting |
Glioblastoma |
2025-06-01 |
24% |
2024-11-01 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05743621 |
NCT05743621 | P1 |
Recruiting |
Prostate Cancer |
2025-11-01 |
50% |
2024-01-18 |
|
NCT06192264 |
ASC40-303 | P3 |
Completed |
Acne Vulgaris |
2025-05-19 |
18% |
2025-06-21 |
Primary Endpoints |
NCT07216313 |
SB2640-CLIN-013 | P1 |
Active, not recruiting |
Healthy Volunteers |
2025-10-20 |
88% |
2025-10-17 |
Primary Endpoints|Treatments|Trial Status |
NCT04906421 |
FASCINATE-2 | P2 |
Completed |
Fatty Liver, Alcoholic|Non-alcoholic Steatohepatitis|Liver Diseases, Alcoholic|Hepatitis, Alcoholic |
2023-10-02 |
37% |
2025-05-10 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT05104125 |
ASC40-202 | P2 |
Completed |
Acne Vulgaris |
2023-04-10 |
50% |
2023-05-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
CTR20212992 |
CTR20212992 | P2 |
Completed |
Acne Vulgaris |
2023-03-10 |
2025-04-29 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/10/2025 |
News Article |
Sagimet Biosciences Presents Two Denifanstat Posters at AASLD—The Liver Meeting® 2025 |
|
10/14/2025 |
News Article |
Sagimet Biosciences Announces Participation in Three Upcoming Investor Conferences |
|
10/14/2025 |
News Article |
Ascletis Completes Denifanstat (ASC40) Pre-NDA Consultation with China National Medical Products Administration |
|
10/07/2025 |
News Article |
Sagimet Biosciences Announces Upcoming Presentation at AASLD—The Liver Meeting® 2025 |
|
03/15/2024 |
PubMed |
FASN Inhibition Decreases MHC-I Degradation and Synergizes with PD-L1 Checkpoint Blockade in Hepatocellular Carcinoma. |
|
03/01/2024 |
PubMed |
Fatty acid synthase (FASN) signalome: A molecular guide for precision oncology. |
|
12/08/2023 |
PubMed |
Lipidomics Profiling Reveals Differential Alterations after FAS Inhibition in 3D Colon Cancer Cell Culture Models. |