Drugs / Denifanstat
Trials 20
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT07216313 | Sep → Oct 2025 | — | Sagimet Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05743621 | Nov 2023 → Jan 2027 expected | castration-resistant prostate carcinoma | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 1 | NCT05835180 | May → Dec 2023 | cirrhosis of liver, metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05657834 | Nov → Dec 2022 | — | Sagimet Biosciences Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04843449 | Apr → May 2021 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04352361 | Apr 2020 | — | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02980029 | Oct 2017 → Oct 2023 | colon carcinoma | Mark Evers | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02223247 | Nov 2013 → Jun 2017 | cancer | Sagimet Biosciences Inc. | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05104125 | Jan 2022 → Apr 2023 | acne | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04906421 | Aug 2021 → Oct 2023 | metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03808558 | Sep 2019 → Apr 2025 overdue | — | David E Gerber | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03938246 | Mar 2019 → Oct 2021 | metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Completed | Mixed |
| Phase 2 | NCT03179904 | Aug 2017 → Jul 2024 | HER2 positive breast carcinoma, female breast carcinoma | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT03032484 | May 2017 → Apr 2020 | astrocytoma (excluding glioblastoma) | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 36 trials · 1 met primary | ||||||
| Phase 3 | NCT07863193 | Oct 2026 → Aug 2027 expected | acne | Sagimet Biosciences Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT06594523 | Mar 2025 → Dec 2030 | metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06692283 | Mar 2025 → Jun 2026 | metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 3 | NCT06248008 | Apr 2024 → Nov 2025 | acne | Ascletis Pharmaceuticals Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT06192264 | Jan 2024 → May 2025 | acne | Ascletis Pharmaceuticals Co., Ltd. | Completed | Met primary |
| Phase 3 | NCT05118776 | Jan 2022 → Jun 2025 overdue | adult glioblastoma | Ascletis Pharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 48
| Date | Issuer | Release |
|---|---|---|
| 2026-10-09 | Sagimet Biosciences Inc. | Results Sagimet To Present Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne and Mechanistic Data at the 2026 Fall Clinical Dermatology Conference sagimet.com ↗
Denifanstat showed continued improvement and sustained efficacy across all efficacy endpoints through 52 weeks, including 57% IGA success, 72% reduction in total lesions, and 77% reduction in inflammatory lesions, and was generally well-tolerated |
| 2026-09-30 | Sagimet Biosciences Inc. | Results Sagimet Announces Positive Full 52-Week Results from License Partner Ascletis' Phase 3 Open-Label Extension Clinical Trial of Denifanstat in Acne Presented at EADV 2026 sagimet.com ↗ |
| 2026-09-28 | Sagimet Biosciences Inc. | Results Sagimet Biosciences to Host Virtual KOL Event, “Denifanstat Update: 52-Week Data from Phase 3 Open-Label Extension in China and Planned AURORA Phase 3 Clinical Trial in US” on September 30, 2026 sagimet.com ↗
In the Phase 3 open-label extension clinical trial, subjects treated with denifanstat showed improvements in all efficacy endpoints (secondary endpoints of the trial) beyond those observed at 12 weeks in the original clinical trial. |
| 2026-08-13 | Sagimet Biosciences Inc. | Regulatory Sagimet Biosciences Receives FDA “Study May Proceed” Letter and IND Clearance for Phase 3 Trial in Acne in Adolescent and Adult Patients sagimet.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application and issued a “Study May Proceed” letter for the company’s Phase 3 clinical trial of fatty acid synthase (FASN) inhibitor denifanstat in moderate to severe acne. |
| 2026-05-27 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Two Posters at EASL 2026 on Denifanstat/Resmetirom Combination in MASH sagimet.com ↗
Combination of denifanstat and resmetirom was generally well-tolerated in Phase 1 clinical trial |
| 2026-04-06 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Poster and Oral Presentations at the Fueling MASH: Metabolic Drivers and Inflammatory Crosstalk Keystone Symposium and Inducement Grant Under Nasdaq Listing Rule 5635(c)(4) sagimet.com ↗
Reduction of plasma glycine- and taurine-conjugated bile acids correlated with histological improvements in denifanstat-treated MASH patients in Phase 2b FASCINATE-2 trial |
| 2026-02-02 | Sagimet Biosciences Inc. | Results Sagimet Announces Positive 52-Week Data from License Partner Ascletis’ Open-Label Phase 3 Clinical Trial Evaluating the Long-Term Safety of ASC40 (Denifanstat) Tablets in Patients with Moderate to Severe Acne sagimet.com ↗ |
| 2026-01-08 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Poster Presentation at the 10th Annual MASH-TAG 2026 Conference sagimet.com ↗
Denifanstat elicited a significant ≥2-stage improvement in fibrosis in F3 MASH patients, and improved liver fibrosis and biomarkers in qFibrosis stage 4 MASH patients: secondary analysis of phase 2b FASCINATE-2 trial |
| 2025-12-18 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Positive Results from the Phase 1 PK Clinical Trial of Denifanstat and Resmetirom Combination sagimet.com ↗
The combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. |
| 2025-12-10 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory 歌礼宣布同类首创FASN抑制剂地尼法司他（ASC40）治疗痤疮的新药上市申请获中国国家药品监督管理局受理 ascletis.com ↗
地尼法司他（ASC40）治疗中重度寻常性痤疮的新药上市申请（NDA）获中国国家药品监督管理局（国家药监局）受理。 |
| 2025-12-10 | Sagimet Biosciences Inc. | Regulatory Sagimet’s License Partner Ascletis Announced Acceptance of New Drug Application for Denifanstat for the Treatment of Moderate to Severe Acne by China’s National Medical Products Administration sagimet.com ↗ |
| 2025-11-10 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Two Denifanstat Posters at AASLD—The Liver Meeting® 2025 sagimet.com ↗
A secondary analysis of FASCINATE-2 Phase 2 trial demonstrated denifanstat improved fibrosis, inflammation and steatosis in advanced qF4 MASH patients as measured by artificial intelligence (AI) digital pathology |
| 2025-10-24 | Sagimet Biosciences Inc. | Results Denifanstat Achieved All Endpoints in the Treatment of Moderate to Severe Acne in Phase 3 Clinical Trial in Acne in China: A Presentation at the 2025 Fall Clinical Dermatology Conference sagimet.com ↗
Denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated in a Phase 3 clinical trial in acne in China conducted by license partner Ascletis |
| 2025-10-07 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Upcoming Presentation at AASLD—The Liver Meeting® 2025 sagimet.com ↗
The analysis showed denifanstat's robust anti-fibrotic effect as measured by both conventional and AI-based digital pathology. |
| 2025-09-17 | Sagimet Biosciences Inc. | Results Positive Phase 3 Results for Denifanstat for the Treatment of Moderate to Severe Acne to be Presented at the EADV Congress 2025 by Partner Ascletis sagimet.com ↗
Denifanstat met all primary and secondary endpoints and was generally well tolerated. |
| 2025-06-09 | Sagimet Biosciences Inc. | Results Sagimet Biosciences to Host Virtual KOL Event, “A New Mechanism of Action in Treating Acne: Update on Positive Phase 3 Denifanstat Trial for the Treatment of Moderate to Severe Acne” on June 16, 2025 sagimet.com ↗
In the Phase 3 study, denifanstat met all primary and secondary endpoints versus placebo and was generally well tolerated. |
| 2025-06-04 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Positive Phase 3 Results for Denifanstat for the Treatment of Moderate-to-Severe Acne from Partner Ascletis sagimet.com ↗
Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) in China. |
| 2025-04-23 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Upcoming Presentations at EASL Congress 2025 sagimet.com ↗
Results demonstrated that, in patients treated with denifanstat, MR-I can predict MASH resolution and potentially can predict non-responders. |
| 2025-02-19 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Oral Presentation at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium sagimet.com ↗
Denifanstat, a Fatty Acid Synthase Inhibitor, Increased Circulating Polyunsaturated Triglycerides and Decreased LDL-Cholesterol in MASH Patients with Advanced Fibrosis in a Post-Hoc Analysis of FASCINATE-2 Study |
| 2024-11-18 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Clinical Denifanstat and Preclinical FASN Inhibitor Data at AASLD - The Liver Meeting® 2024 sagimet.com ↗
Subset analysis of FASCINATE-2 Phase 2 trial demonstrated denifanstat improved fibrosis in difficult-to-treat MASH patients |
| 2024-10-16 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Upcoming Presentations at AASLD - The Liver Meeting® 2024 sagimet.com ↗
Denifanstat, an oral FASN inhibitor, demonstrated statistically significant MASH resolution and fibrosis improvement and decreased liver fat and biomarkers of inflammation and fibrosis in the Phase 2b study FASCINATE-2. |
| 2024-10-11 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Publication of Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 MASH in The Lancet Gastroenterology & Hepatology sagimet.com ↗
The publication, “Denifanstat for the treatment of Metabolic-dysfunction Associated Steatohepatitis: a multicentre, double-blind, randomised, placebo-controlled, ph2b trial,” reported that treatment with denifanstat achieved statistically significant and clinically meaningful improvements in disease activity, MASH resolution and fibrosis. |
| 2024-10-01 | Sagimet Biosciences Inc. | Regulatory Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH sagimet.com ↗
Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to denifanstat for treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). |
| 2024-06-06 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Data from ITT and F3 Patient Population in Phase 2b FASCINATE-2 Clinical Trial of Denifanstat at EASL International Liver Congress 2024 sagimet.com ↗
Denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints in the ITT population, including both histology endpoints recommended in the FDA draft guidance for accelerated approval in MASH |
| 2024-05-07 | Sagimet Biosciences Inc. | Results Sagimet Announces Oral Presentation of Data from the Phase 2b FASCINATE-2 Study of Denifanstat in MASH at EASL International Liver Congress 2024 sagimet.com ↗
Denifanstat, a fatty acid synthase (FASN) inhibitor, shows significant fibrosis improvement and MASH resolution in FASCINATE-2, a Ph2b 52 week international, randomized, double blind, placebo-controlled trial in patients with F2 or F3 fibrosis. |
| 2024-03-27 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Completion of Phase 1 Hepatic Impairment Study with FASN Inhibitor Denifanstat sagimet.com ↗
Denifanstat was well-tolerated and no safety signals were reported. |
| 2024-03-11 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentation of Phase II Study Final Results of FASN Inhibitor ASC40 for Treatment of Acne at 2024 AAD Annual Meeting ascletis.com ↗
At all doses, above efficacy measures generally improved from week 2 to week 12. |
| 2024-01-23 | Ascletis Pharmaceuticals Co., Ltd. | Results Gannex’s Strategic Partner Sagimet Biosciences Announces Positive Topline Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH ascletis.com ↗
In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of NASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis. |
| 2024-01-22 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Positive Topline Results from Phase 2b FASCINATE-2 Clinical Trial of Denifanstat in Biopsy-Confirmed F2/F3 NASH sagimet.com ↗
Denifanstat achieved statistically significant results on primary and multiple secondary endpoints in a 52-week clinical trial of 168 NASH patients with stage 2 or 3 fibrosis |
| 2023-11-28 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Oral Presentation of Preclinical Results of FASN Inhibitor in Combination with Semaglutide at the 7th Obesity and NASH Drug Development Summit sagimet.com ↗
We are pleased to report strong preclinical combination results demonstrating that the FASN inhibitor alone, not semaglutide, was responsible for significant reduction of liver fibrosis, a predictor of outcome in NASH, |
| 2023-11-10 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Preclinical Results Supporting the Therapeutic Potential of its FASN inhibitor in Combination with Semaglutide and a Comprehensive Lipidomic Analysis of Interim FASCINATE-2 Data at AASLD - The Liver Meeting® 2023 sagimet.com ↗
Reductions of circulating lipids associated with cardiovascular risk were observed in denifanstat-treated patients in the FASCINATE-2 Phase 2b clinical trial interim analysis, with numerical separation from placebo at Week 4 and statistically significant responses at Week 13 |
| 2023-10-24 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Acceptance of Two Abstracts at AASLD - The Liver Meeting® 2023 sagimet.com ↗
Interim analysis of FASCINATE-2 a Phase 2b randomized, placebo controlled trial demonstrates denifanstat reduces circulating saturated diacylglycerols and triacylglycerols, markers of lipotoxicity |
| 2023-10-11 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Poster Presentation of Phase II Study Topline Results of FASN Inhibitor ASC40 for Treatment of Acne at EADV Congress 2023 ascletis.com ↗
Ascletis Pharma Inc. (HKEX:1672, “Ascletis”) today announces the poster presentation of Phase II study topline results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany. |
| 2023-06-23 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Presents Positive Phase 2b FASCINATE-2 Clinical Trial Interim Data for Denifanstat for the Treatment of NASH at EASL Congress 2023 sagimet.com ↗
Denifanstat was well-tolerated and met primary endpoint in planned interim readout with 67% of treated patients achieving ≥30% reductions in liver fat at week 26 compared to 18% placebo (p<0.001) as assessed by MRI-PDFF |
| 2022-11-30 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis Announces Completion of 180 Patient Enrollment for Phase II Clinical Trial of FASN Inhibitor ASC40 for Acne ascletis.com ↗
To date, the preliminary data also indicated that ASC40 or placebo treatment in acne patients is safe and well tolerated, and majority of treatment-related adverse events are grade 1. |
| 2022-11-03 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Positive Interim Phase 2b Clinical Trial Data with Denifanstat (TVB-2640), a First-in-Class Fatty Acid Synthase Inhibitor, in Moderate-to-Severe Non-alcoholic Steatohepatitis (NASH) Patients sagimet.com ↗
Data showed statistically significant improvements across key markers of NASH, reinforcing results observed in earlier studies, including statistically significant reductions in markers of liver fat, inflammation and fibrosis. |
| 2022-06-08 | Sagimet Biosciences Inc. | Results Sagimet Biosciences Announces Presentation of Additional Phase 2 Data on Denifanstat Identifying a Predictive Metabolic Signature in NASH Patients at EASL’s International Liver Congress (ILC) 2022 sagimet.com ↗
announced today that it will present additional Phase 2 data on denifanstat (formerly TVB-2640) identifying a predictive ‘metabolic signature’ in nonalcoholic steatohepatitis (NASH) patients. |
| 2022-05-04 | Sagimet Biosciences Inc. | Results Sagimet Biosciences to Present Additional Biomarker Phase 2 Data on Denifanstat (TVB-2640) in NASH Patients at DDW 2022 sagimet.com ↗ |
| 2021-11-12 | Sagimet Biosciences Inc. | Results New Data from Sagimet’s Phase 2 FASCINATE-1 Clinical Trial Demonstrate TVB-2640’s Positive Effect Across Patients with NASH in the U.S. and China sagimet.com ↗
We are encouraged that despite different patient populations, the results were consistent between U.S. and Chinese cohorts including reduction in liver fat, which has been shown in multiple studies to correlate with histological response. |
| 2021-10-13 | Ascletis Pharmaceuticals Co., Ltd. | Results Gannex Announces Clinical and Preclinical Data of Four NASH Programs to be Presented in Oral or Poster Presentation at The Liver Meeting® 2021 by American Association for the Study of Liver Diseases ascletis.com ↗
NOVEL, FIRST-IN-CLASS, FATTY ACID SYNTHASE (FASN) INHIBITOR TVB-2640 DEMONSTRATES ROBUST CLINICAL EFFICACY AND SAFETY IN A GLOBAL PHASE 2 RANDOMIZED PLACEBO-CONTROLLED NASH TRIAL (FASCINATE-1) CONDUCTED IN THE US AND CHINA |
| 2021-10-04 | Sagimet Biosciences Inc. | Results Sagimet to Present Data from Phase 2 FASCINATE-1 Trial of TVB-2640 in NASH at AASLD's The Liver Meeting 2021 sagimet.com ↗
In this randomized, placebo-controlled trial, TVB-2640, a novel, first-in-class, FASN inhibitor, significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety and tolerability profile. |
| 2021-07-26 | Sagimet Biosciences Inc. | Results Published Results from Sagimet's FASCINATE-1 Phase 2a Trial Demonstrate FASN Inhibitor TVB-2640's Ability to Significantly Reduce Excess Liver Fat sagimet.com ↗
The significant improvement across steatosis, inflammation, lipotoxicity, fibrosis and metabolic biomarkers after only 12 weeks of TVB-2640 treatment brings hope that we are getting closer to a potential therapy for patients with NASH. |
| 2021-03-16 | Sagimet Biosciences Inc. | Regulatory Sagimet Biosciences Receives Fast Track Designation from U.S. Food and Drug Administration for FASN Inhibitor TVB-2640 in NASH sagimet.com ↗
The FDA's Fast Track designation for TVB-2640 demonstrates recognition of TVB-2640's potential to address unmet needs of NASH patients. |
| 2021-03-08 | Sagimet Biosciences Inc. | Results FASN Inhibitor ASC40 Demonstrates Positive Phase 2 Topline Clinical Results from China Cohort of Patients with NASH sagimet.com ↗
The preliminary data showed that ASC40 meaningfully reduced liver fat, the primary efficacy endpoint of this trial, with a 50% responder rate (patients achieving ≥30% reduction). |
| 2020-10-10 | Ascletis Pharmaceuticals Co., Ltd. | Results Ascletis’ Strategic Partner Sagimet to Present Data from Phase 2 FASCINATE-1 Trial of TVB-2640(ASC40) in NASH at AASLD’s The Liver Meeting Digital Experience™ 2020 ascletis.com ↗
In this randomized, placebo-controlled trial, a novel, first-in-class, FASN inhibitor, TVB-2640 significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety profile and tolerability. |
| 2020-10-06 | Sagimet Biosciences Inc. | Results Sagimet to Present Data from Phase 2 FASCINATE-1 Trial of TVB-2640 in NASH at AASLD's The Liver Meeting Digital Experience™ 2020 sagimet.com ↗
In this randomized, placebo-controlled trial, a novel, first-in-class, FASN inhibitor, TVB-2640 significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety profile and tolerability. |
| 2020-06-17 | Sagimet Biosciences Inc. | Results Sagimet Announces Positive Topline Results in 12-week NASH Phase 2 Clinical Trial of FASN Inhibitor TVB-2640 sagimet.com ↗
The preliminary data showed that TVB-2640 significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. |
| 2019-08-28 | Ascletis Pharmaceuticals Co., Ltd. | Regulatory Ascletis Received IND Approval for its NASH Drug ascletis.com ↗
Ascletis Pharma Inc. (1672.HK), an innovative R&D driven, commercial-stage biotechnology company addressing unmet medical needs in therapeutic areas including anti-viral, cancer and fatty liver diseases, announces today that together with Sagimet Biosciences (formerly 3-V Biosciences, Inc), it received, through its subsidiary, IND approval from National Medical Products Administration (NMPA) for its non-alcoholic steatohepatitis (NASH) drug candidate ASC40 (Sagimet Biosciences code: TVB-2640). |
All press releases naming this drug 68 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Denifanstat | “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” NCT05835180 ↗7“A Study to Evaluate the Safety and Efficacy of ASC40 (Denifanstat) Tablets in the Treatment of Patients With Moderate to Severe Acne Vulgaris” NCT06192264 ↗ “ASC40 (Denifanstat) tablets” NCT06248008 ↗ |
| Known as | ASC 40 | “ASC 40 tablets orally once daily” NCT06192264 ↗ |
| Known as | TVB-2640 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05835180 ↗ |
| Action | Inhibit | “Target engagement (FASN inhibition) and inhibition of lipogenesis were demonstrated with TVB-2640.” PMID 33870151 ↗ Mar 2021 |
| Modality | Small molecule | — CHEMBL3661754 ↗ |
| Route | Oral | “TVB-2640 was administered orally daily until PD.” PMID 33870151 ↗ Mar 2021 |
| Target | FASN | “TVB-2640 belongs to a class of drugs called fatty acid synthase inhibitors (FASN inhibitors).” NCT02223247 ↗ |