Drugs / Clesacostat
Clesacostat
Trials 9
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT03871439 | Mar → May 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03597217 | Aug → Nov 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03534648 | Apr → Jul 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03448172 | Apr → May 2018 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03309202 | Dec 2017 → Jun 2018 | liver disease, severe congenital | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02871037 | Aug 2016 → Mar 2017 | — | Pfizer | Completed | No outcome recorded |
| Phase 23 trials · 2 met primary | ||||||
| Phase 2 | NCT04399538 | Aug 2020 → Mar 2022 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Pfizer | Completed | Met primary |
| Phase 2 | NCT04321031 | Jun 2020 → Jan 2024 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03776175 | Jan → Sep 2019 | NAFLD1 | Pfizer | Completed | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT04395950 Comparator | Dec 2020 → Aug 2021 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Columbia University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03248882 Comparator | Aug 2017 → Feb 2019 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2022-05-26 | Pfizer | Regulatory Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis (NASH) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Pfizer’s investigational combination therapy for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis: ervogastat (PF-06865571, a diacylglycerol O-acyltransferase 2 inhibitor, or DGAT2i) and clesacostat (PF-05221304, an acetyl-CoA carboxylase inhibitor, or ACCi). |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2022-05-26 | Pfizer | Pfizer Granted FDA Fast Track Designation for Ervogastat/Clesacostat Combination for the Treatment of Non-Alcoholic Steatohepatitis (NASH) pfizer.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | clesacostat | “with Clesacostat (PF-05221304), an acetyl coA carboxylase inhibitor (ACCi) in patients with NAFLD/NASH.” PMID 39048608 ↗ Jul 20241“acetyl-coenzyme A carboxylase inhibitor (ACCi, PF-05221304, clesacostat)” PMID 35354614 ↗ Mar 2022 |
| Known as | PF'1304 | “The purpose of this study is to assess the effects of an investigational drug, PF-05221304 (PF'1304) on the way the liver handles fat.” NCT04395950 ↗ |
| Known as | PF-05221304 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04399538 ↗ |
| Action | Inhibit | “Clesacostat (PF-05221304), an acetyl coA carboxylase inhibitor (ACCi)” PMID 39048608 ↗ Jul 2024 |
| Modality | Small molecule | “Small molecule inhibitors of the terminal step in intrahepatic triglyceride synthesis (diacylglycerol acyltransferase 2 inhibitor (DGAT2i, PF-06865571, ervogastat)) and...” PMID 35354614 ↗ Mar 2022 |
| Route | Oral | “Oral Doses” NCT02871037 ↗ |