Clinical Trials

Multiple clinical trials sponsored by Gilead Sciences evaluate the therapeutic profile of cilofexor (GS-9674) across Phase 1, Phase 2, and Phase 3 investigations targeting chronic liver diseases, including nonalcoholic steatohepatitis (NASH), primary sclerosing cholangitis (PSC), primary biliary cholangitis, and compensated cirrhosis. While several Phase 1 pharmacokinetic trials and Phase 2 efficacy studies have been completed, select advanced protocols, including a Phase 3 trial in PSC, were terminated prior to completion.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04971785 COMPLETED
Nonalcoholic Steatohepatitis
Gilead Sciences
 2021-08-09 PHASE2
NCT03890120 TERMINATED
Primary Sclerosing Cholangitis
Gilead Sciences
 2019-03-27 PHASE3
NCT04060147 TERMINATED
Primary Sclerosing Cholangitis; Compensated Cirrhosis
Gilead Sciences
 2019-10-17 PHASE1
NCT03987074 COMPLETED
Nonalcoholic Steatohepatitis
Gilead Sciences
 2019-07-29 PHASE2
NCT03449446 COMPLETED
Nonalcoholic Steatohepatitis
Gilead Sciences
 2018-03-21 PHASE2
NCT02943447 TERMINATED
Primary Biliary Cholangitis
Gilead Sciences
 2016-12-01 PHASE2
NCT02808312 COMPLETED
Nonalcoholic Steatohepatitis (NASH); Primary Sclerosing Cholangitis (PSC)
Gilead Sciences
 2016-07-13 PHASE1
NCT02943460 COMPLETED
Primary Sclerosing Cholangitis
Gilead Sciences
 2016-11-29 PHASE2
NCT02854605 COMPLETED
Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences
 2016-10-26 PHASE2
NCT02654002 COMPLETED
Nonalcoholic Steatohepatitis (NASH)
Gilead Sciences
 2016-01-20 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-11-26)

Check the Cilofexor (GS-9674) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Cilofexor (GS-9674) acts as a potent, selective oral agonist of the farnesoid X receptor (FXR) with an EC50 of 43 nM, modulating transcriptional cascades that control bile acid homeostasis, lipid metabolism, and inflammatory signaling. This receptor activation suppresses hepatic steatosis, reduces inflammatory signaling, and lowers portal pressure, thereby limiting liver tissue remodeling in clinical conditions like nonalcoholic steatohepatitis and primary sclerosing cholangitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.