Clinical Trials

Denifanstat (TVB-2640), a fatty acid synthase inhibitor, has been evaluated in numerous clinical trials spanning Phase 1 through Phase 3 for metabolic disorders such as nonalcoholic steatohepatitis and fatty liver disease, dermatological conditions like acne, and solid tumors including prostate, breast, and colon cancers. Sponsored by organizations such as Sagimet Biosciences, Ascletis Pharmaceuticals, Weill Medical College of Cornell University, and Mayo Clinic, these studies encompass various recruitment statuses, including recruiting, active not recruiting, completed, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06594523 WITHDRAWN
MASH; NASH; Metabolic Dysfunction-associated Steatohepatitis; Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver
Sagimet Biosciences Inc.
 2025-03 PHASE3
NCT05743621 RECRUITING
Prostatic Neoplasms, Castration-Resistant
Weill Medical College of Cornell University
 2023-11-20 PHASE1
NCT06692283 WITHDRAWN
MASLD; MASH; NASH; Metabolic Dysfunction-Associated Steatotic Liver Disease; Metabolic Dysfunction-Associated Steatohepatitis; Nonalcoholic Steatohepatitis; Nonalcoholic Fatty Liver
Sagimet Biosciences Inc.
 2025-03 PHASE3
NCT06248008 COMPLETED
Acne
Ascletis Pharmaceuticals Co., Ltd.
 2024-04-18 PHASE3
NCT07216313 COMPLETED
Healthy
Sagimet Biosciences Inc.
 2025-09-30 PHASE1
NCT06192264 COMPLETED
Acne
Ascletis Pharmaceuticals Co., Ltd.
 2024-01-23 PHASE3
NCT03808558 ACTIVE_NOT_RECRUITING
KRAS Gene Mutation
David E Gerber
 2019-09-11 PHASE2
NCT03179904 COMPLETED
Advanced Breast Carcinoma; HER2-Positive Breast Carcinoma; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; HER2-positive Breast Cancer
Mayo Clinic
 2017-08-03 PHASE2
NCT05835180 COMPLETED
Non-alcoholic Steatohepatitis; Hepatic Impairment; Cirrhosis
Sagimet Biosciences Inc.
 2023-05-01 PHASE1
NCT05743621 Recruiting
Prostatic Neoplasms Castration-Resistant
Weill Medical College of Cornell University|Sagimet Biosciences Inc.
 2023-11-20 Phase 1
NCT02980029 TERMINATED
Colon Cancer
Mark Evers
 2017-10-06 PHASE1
NCT04906421 COMPLETED
Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
Sagimet Biosciences Inc.
 2021-08-12 PHASE2
NCT05835180 Completed
Non-alcoholic Steatohepatitis|Hepatic Impairment|Cirrhosis
Sagimet Biosciences Inc.
 2023-05-01 Phase 1
NCT05657834 COMPLETED
Healthy Volunteers
Sagimet Biosciences Inc.
 2022-11-21 PHASE1
NCT05657834 Completed
Healthy Volunteers
Sagimet Biosciences Inc.
 2022-11-21 Phase 1
NCT03938246 COMPLETED
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Sagimet Biosciences Inc.
 2019-03-22 PHASE2
NCT04906421 Completed
Nonalcoholic Fatty Liver Disease
Sagimet Biosciences Inc.
 2021-08-12 Phase 2
NCT04843449 Completed
Healthy
Ascletis Pharmaceuticals Co. Ltd.
 2021-04-04 Phase 1
NCT04352361 COMPLETED
Healthy
Ascletis Pharmaceuticals Co., Ltd.
 2020-04-02 PHASE1
NCT03032484 COMPLETED
Astrocytoma
The University of Texas Health Science Center at San Antonio
 2017-05-18 PHASE2
NCT04352361 Completed
Healthy
Ascletis Pharmaceuticals Co. Ltd.
 2020-04-02 Phase 1
NCT02223247 COMPLETED
Solid Malignant Tumor
Sagimet Biosciences Inc.
 2013-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-05-15)

Check the Denifanstat (TVB-2640) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Denifanstat selectively binds to and inhibits fatty acid synthase (FAS/FASN), blocking de novo lipogenesis and altering cellular lipid membrane dynamics. This enzymatic disruption reduces intracellular lipid accumulation and suppresses tumor cell proliferation, demonstrating clinical relevance across targeted clinical trials for metabolic dysfunction-associated steatohepatitis and fatty acid-dependent malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.