Drugs / Firsocostat
Firsocostat
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02891408 | Sep 2016 → May 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02876796 | Aug → Sep 2015 | — | Gilead Sciences | Completed | No outcome recorded |
| Phase 25 trials · 2 missed | ||||||
| Phase 2 | NCT04971785 | Aug 2021 → Nov 2024 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT03987074 | Jul 2019 → Jul 2020 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT03449446 | Mar 2018 → Oct 2019 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | Missed primary |
| Phase 2 | NCT02856555 | Aug 2016 → Jul 2017 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02781584 | Jun 2016 → Dec 2020 | NAFLD1, metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2021-06-21 | Gilead Sciences | Results Gilead to Present More Than 70 Abstracts From Diverse Liver Disease Programs At The International Liver Congress™ 2021 gilead.com ↗
Cilofexor and firsocostat treatment is associated with widespread changes in the hepatic transcriptome in NASH patients with advanced fibrosis |
| 2020-11-15 | Novo Nordisk A/S | Results Gilead and Novo Nordisk present new data from proof-of-concept trial in NASH novonordisk.com ↗
The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. |
| 2020-11-15 | Gilead Sciences | Results Gilead and Novo Nordisk Present New Data from Proof-of-Concept Trial in NASH gilead.com ↗
The trial met its primary endpoint by demonstrating that in people with NASH and mild to moderate fibrosis all regimens were well tolerated. |
| 2019-12-16 | Gilead Sciences | Results Gilead Announces Topline Results From Phase 2 ATLAS Study in Patients With Bridging Fibrosis (F3) and Compensated Cirrhosis (F4) Due to Nonalcoholic Steatohepatitis (NASH) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. |
| 2019-11-08 | Gilead Sciences | Results Data Showing Potential for Machine Learning to Advance Understanding of Nonalcoholic Steatohepatitis (NASH) Presented at the Liver Meeting® 2019 gilead.com ↗
New Results Show Fenofibrate Mitigates Increases in Serum Triglycerides in NASH Patients Treated With Investigational Firsocostat |
| 2019-04-11 | Gilead Sciences | Results Gilead Presents New Data in Nonalcoholic Steatohepatitis (NASH) at the International Liver Congress™ 2019 gilead.com ↗
A proof-of-concept study demonstrated that the combination of the investigational, selective, non-steroidal farnesoid X receptor (FXR) agonist cilofexor (GS-9674) and the acetyl-CoA carboxylase (ACC) inhibitor firsocostat (GS-0976) resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers. |
| 2019-03-27 | Gilead Sciences | Results Gilead to Present New Data From Multiple Liver Disease Research and Development Programs at The International Liver Congress™ 2019 gilead.com ↗
A combination of the ACC inhibitor GS-0976 and the non-steroidal FXR agonist GS-9674 improves hepatic steatosis and liver stiffness in patients with nonalcoholic steatohepatitis (NASH): a proof-of-concept study (poster #0352) |
| 2018-04-13 | Gilead Sciences | Results Gilead Presents Data on Multiple Investigational Regimens for the Treatment of Patients With Nonalcoholic Steatohepatitis (NASH) and Advanced Fibrosis at The International Liver Congress™ 2018 gilead.com ↗
The initial data presented today are important advances toward our goal of improving outcomes for patients with advanced fibrosis due to NASH. |
| 2017-10-24 | Gilead Sciences | Results Gilead Announces Phase 2 Results for GS-0976 in Nonalcoholic Steatohepatitis (NASH) gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis (NASH). |
| 2017-04-21 | Gilead Sciences | Results Gilead Presents Proof-of-Concept Data for GS-0976 in Nonalcoholic Steatohepatitis (NASH) at The International Liver Congress™ 2017 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq:GILD) today announced results from an open-label, proof-of-concept study evaluating GS-0976, an investigational inhibitor of Acetyl-CoA carboxylase (ACC), in patients with nonalcoholic steatohepatitis ( NASH ). |
All press releases naming this drug 10 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Firsocostat | “the acetyl-CoA carboxylase inhibitor firsocostat (FIR) improved liver histology and biomarkers in NASH with advanced fibrosis” PMID 34999207 ↗ Jan 2022 |
| Known as | FIR | “the acetyl-CoA carboxylase inhibitor firsocostat (FIR) improved liver histology and biomarkers in NASH with advanced fibrosis” PMID 34999207 ↗ Jan 2022 |
| Known as | GS-0976 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02876796 ↗ |
| Known as | GS-ACC | ChEMBL registry synonym — accepted as the source's own label CHEMBL3407547 ↗ |
| Known as | ND-630 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3407547 ↗ |
| Known as | Ndi-010976 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3407547 ↗ |
| Action | Inhibit | “the acetyl-CoA carboxylase inhibitor firsocostat (FIR)” PMID 34999207 ↗ Jan 2022 |
| Modality | Small molecule | — CHEMBL3407547 ↗ |
| Route | Oral | “Administered orally once daily” NCT02781584 ↗ |