Drugs / Cilofexor
Trials 13
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04060147 | Oct 2019 → Sep 2021 | cirrhosis of liver, primary sclerosing cholangitis | Gilead Sciences | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02808312 | Jul 2016 → Oct 2018 | metabolic dysfunction-associated steatohepatitis, primary sclerosing cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 1 | NCT02654002 | Jan → Jul 2016 | metabolic dysfunction-associated steatohepatitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 29 trials · 2 missed | ||||||
| Phase 2 | NCT07841977 | Oct 2026 → Jun 2028 expected | primary biliary cholangitis | Gilead Sciences | Not yet recruiting | No outcome recorded |
| 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 | NCT02943447 | Dec 2016 → Sep 2019 | primary biliary cholangitis | Gilead Sciences | Terminated | No outcome recorded |
| Phase 2 | NCT02943460 | Nov 2016 → Feb 2018 | primary sclerosing cholangitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2 | NCT02854605 | Oct 2016 → Jan 2018 | 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 |
| Phase 2 | NCT01999101 | Oct 2013 → Jan 2015 | NAFLD1 | Phenex Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 31 trial · 1 missed | ||||||
| Phase 3 | NCT03890120 | Mar 2019 → Nov 2022 | primary sclerosing cholangitis | Gilead Sciences | Terminated | Missed primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2022-11-01 | Gilead Sciences | Results Gilead to Present Data Across Viral Hepatitis and Liver Fibrosis at The Liver Meeting® 2022, Reinforcing Gilead as a Leader in Addressing Treatment Needs for People Living With Liver Disease gilead.com ↗
Gilead will present data from the Phase 2b ATLAS Study utilizing SomaScan ® plasma proteome analysis in people with NASH with advanced fibrosis, demonstrating specific activity of combination therapy with investigational compounds, cilofexor and firsocostat, compared to monotherapies (OS-75). |
| 2022-06-21 | Gilead Sciences | Results Gilead to Present Latest Data From Across Liver Disease Development Programs at the International Liver Congress™ 2022 gilead.com ↗
The study found escalating doses of cilofexor over 12 weeks were well tolerated and showed improved markers of cholestasis and liver biochemistry. |
| 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. |
| 2020-08-25 | Gilead Sciences | Results Gilead Announces Presentation of More Than 40 Abstracts From Extensive Liver Disease Programs at the Digital International Liver Congress™ 2020 gilead.com ↗
This combination resulted in meaningful improvement in secondary endpoints including a ≥2-point reduction in the NAFLD Activity Score (NAS), and ≥1-grade reductions in steatosis, hepatocellular ballooning and lobular inflammation. |
| 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. |
| 2019-04-11 | 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 ↗
High efficacy and improvement in CPT class with sofosbuvir/velpatasvir plus ribavirin for 12 weeks in patients with CPT C decompensated cirrhosis |
| 2018-11-09 | Gilead Sciences | Results Gilead Presents Data From Nonalcoholic Steatohepatitis (NASH) Development Program for Advanced Fibrosis at The Liver Meeting® 2018 gilead.com ↗
A decline of at least 30 percent in hepatic fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) was observed in 38.9 percent of patients treated with GS-9674 100 mg (p=0.011 vs placebo), 14 percent treated with GS-9674 30 mg (p=0.87), and 12.5 percent with placebo. |
| 2018-11-09 | Gilead Sciences | Results Gilead Announces Positive Phase 2 Results for GS-9674 in Primary Sclerosing Cholangitis (PSC) at The Liver Meeting® 2018 gilead.com ↗
Gilead Sciences, Inc. (Nasdaq: GILD) today announced that treatment with GS-9674, an investigational, selective, nonsteroidal farnesoid X receptor (FXR) agonist, led to significant improvements in liver biochemistry and markers of cholestasis in patients with primary sclerosing cholangitis (PSC). |
| 2018-10-11 | Gilead Sciences | Results Gilead to Present Wide-Ranging New Data on Treatment and Diagnosis of Liver Diseases at The Liver Meeting® 2018 gilead.com ↗
Sofosbuvir/velpatasvir for 12 weeks is safe and effective in patients undergoing dialysis |
| 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. |
All press releases naming this drug 13 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 16 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | cilofexor | “the farnesoid X receptor agonist cilofexor (CILO) and the acetyl-CoA carboxylase inhibitor firsocostat (FIR) improved liver histology and biomarkers in NASH with advanced fibrosis” PMID 34999207 ↗ Jan 202211“BACKGROUND AND AIMS: We evaluated the safety and efficacy of cilofexor (formerly GS-9674), a small-molecule nonsteroidal agonist of farnesoid X receptor” PMID 32115759 ↗ Jul 2020 “Cilofexor (CILO)” NCT03449446 ↗ |
| Known as | CILO | “the farnesoid X receptor agonist cilofexor (CILO) and the acetyl-CoA carboxylase inhibitor firsocostat (FIR) improved liver histology and biomarkers in NASH with advanced fibrosis” PMID 34999207 ↗ Jan 20223“Seladelpar (SEL) 10 mg + Placebo-to-Match (PTM) Cilofexor (CILO) Dose A + CILO Dose B” NCT07841977 ↗ “Cilofexor (CILO)/Firsocostat (FIR)” NCT04971785 ↗ “Cilofexor (CILO)” NCT03449446 ↗ |
| Known as | GS-9674 | “A Phase 1 Open-Label, Parallel-Group, Adaptive, Single-Dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of GS-9674 in Subjects With Normal and Impaired Hepatic Function” NCT02808312 ↗ |
| Known as | Px-104 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01999101 ↗ |
| Action | Activate | “Farnesoid X Receptor (FXR) Agonist” NCT01999101 ↗1“Bile acid receptor FXR agonist” CHEMBL4297613 ↗ |
| Modality | Small molecule | “a small-molecule nonsteroidal agonist of farnesoid X receptor” PMID 32115759 ↗ Jul 2020 |
| Route | Oral | “Administered orally once daily” NCT02781584 ↗ |
| Target | NR1H4 | “Bile acid receptor FXR agonist” CHEMBL4297613 ↗ |