Denifanstat
- Generic Name
- Denifanstat
- Drug Type
- Small Molecule
- Chemical Formula
- C27H29N5O
- CAS Number
- 1399177-37-7
- Unique Ingredient Identifier
- 4GF95B2LZA
- Background
Denifanstat is an orally bioavailable fatty acid synthase (FASN) inhibitor. Due to its antineoplastic activities, it is being investigated for various cancers.
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
- Conditions
- Nonalcoholic SteatohepatitisNonalcoholic Fatty LiverMASLDMASHNASHMetabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated Steatohepatitis
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-11-18
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 2000
- Registration Number
- NCT06692283
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
- Conditions
- MASHNASHMetabolic Dysfunction-associated SteatohepatitisNoncirrhotic Metabolic Dysfunction-associated SteatohepatitisNonalcoholic SteatohepatitisNonalcoholic Fatty Liver
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 1260
- Registration Number
- NCT06594523
A Study to Evaluate Safety of ASC40 Tablets in Patients with Moderate to Severe Acne Vulgaris
- First Posted Date
- 2024-02-08
- Last Posted Date
- 2025-03-12
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 240
- Registration Number
- NCT06248008
- Locations
- 🇨🇳
Huashan Hospital Fudan University, Shanghai, Shanghai, China
A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris
- First Posted Date
- 2024-01-05
- Last Posted Date
- 2024-11-22
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 480
- Registration Number
- NCT06192264
- Locations
- 🇨🇳
Huashan Hospital Fudan University, Shanghai, Shanghai, China
Study of TVB-2640 in Men With Metastatic Castration-Resistant Prostate Cancer
- Conditions
- Prostatic Neoplasms, Castration-Resistant
- Interventions
- First Posted Date
- 2023-02-24
- Last Posted Date
- 2024-12-27
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 30
- Registration Number
- NCT05743621
- Locations
- 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
- First Posted Date
- 2022-12-20
- Last Posted Date
- 2022-12-28
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 8
- Registration Number
- NCT05657834
- Locations
- 🇺🇸
Celerion Inc., Lincoln, Nebraska, United States
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
- Conditions
- Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
- Interventions
- Other: Placebo
- First Posted Date
- 2021-05-28
- Last Posted Date
- 2025-05-09
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 168
- Registration Number
- NCT04906421
- Locations
- 🇵🇱
Warsaw IBD Point Profesor Kierkus, Warsaw, Poland
🇵🇱Centrum Medyczne K2J2, Wołomin, Poland
🇵🇱FutureMeds, Wrocław, Poland
Study to Evaluate the Effects of Itraconazole and Rifampin on the Pharmacokinetics of ASC40 in Healthy Subjects
- First Posted Date
- 2021-04-13
- Last Posted Date
- 2021-08-23
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 24
- Registration Number
- NCT04843449
- Locations
- 🇨🇳
Hunan provincial people's hospital, Changsha, Hunan, China
Ascending Single-dose Study to Evaluate TVB-2640 in Chinese Healthy Subjects
- First Posted Date
- 2020-04-20
- Last Posted Date
- 2020-07-07
- Lead Sponsor
- Ascletis Pharmaceuticals Co., Ltd.
- Target Recruit Count
- 34
- Registration Number
- NCT04352361
- Locations
- 🇨🇳
Hunan provincial people's hospital, Changsha, Hunan, China
Phase 2 Study of TVB-2640 in KRAS Non-Small Cell Lung Carcinomas
- First Posted Date
- 2019-01-17
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- David E Gerber
- Target Recruit Count
- 34
- Registration Number
- NCT03808558
- Locations
- 🇺🇸
University of Cincinnati, Cincinnati, Ohio, United States
🇺🇸University of Texas Southwestern Medical Center, Dallas, Texas, United States
Drug Development Updates
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