Drugs / Denifanstat
Trials 19 · a red edge is where a trial was stopped
| 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 |
| 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 | No outcome recorded |
| 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 35 trials | ||||||
| Phase 3 | NCT06692283 | Mar 2025 → Jun 2026 | metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT06594523 | Mar 2025 → Dec 2030 | metabolic dysfunction-associated steatohepatitis | Sagimet Biosciences Inc. | Withdrawn | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT05118776 | Jan 2022 → Jun 2025 overdue | adult glioblastoma | Ascletis Pharmaceuticals Co., Ltd. | Active not recruiting | No outcome recorded |
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 21 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 ↗6“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 NCT04352361 ↗ |
| 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 ↗ |