Cilofexor

drug
On this page

Also known as GS 9674Gs-9674PX-104PX104Cliofexor

Summary

Cilofexor (CHEMBL4297613) is a phase-3 clinical-stage small molecule targeting EPHA2 and NR1H4; indicated across 4 conditions including sclerosing cholangitis and metabolic dysfunction-associated steatohepatitis.

At a glance

  • Status: Max clinical phase 3 (not approved)
  • Modality: Small molecule
  • Targets: 2 (EPHA2, NR1H4)
  • Indications: 4 conditions
  • Clinical trials: 9
  • Chemistry: 586.8 Da · C28H22Cl3N3O5

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL4297613
NameCilofexor
TypeSmall molecule
Max phase3
FDA approvedno
PubChem CID71228883
Molecular formulaC28H22Cl3N3O5
Molecular weight586.8
InChIKeyKZSKGLFYQAYZCO-UHFFFAOYSA-N

SMILES: C1CC1C2=C(C(=NO2)C3=C(C=CC=C3Cl)Cl)COC4=CC(=C(C=C4)C5(CN(C5)C6=NC=CC(=C6)C(=O)O)O)Cl

IUPAC name: 2-[3-[2-chloro-4-[[5-cyclopropyl-3-(2,6-dichlorophenyl)-1,2-oxazol-4-yl]methoxy]phenyl]-3-hydroxyazetidin-1-yl]pyridine-4-carboxylic acid

Also known as: Cilofexor, GS 9674, Gs-9674, GS-9674, PX-104, PX104, CILOFEXOR, Cliofexor

Patent coverage: 461 distinct patent families (1,374 SureChEMBL compound mentions), from 3 matched compound structure(s). One matched structure accounts for 1,293 (94%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Primary targets (GtoPdb curated mechanism): the Cancer dependency column is the DepMap CRISPR fitness signal (% of screened cell lines dependent on the target).

GeneTargetActionpAffinityCancer dependencyUniProt
EPHA2EPH receptor A2Inhibition5.070.1%P29317
NR1H4Farnesoid X receptorAgonist7.60.7%Q96RI1

Broader ChEMBL bioactivity targets: 2 (assay-derived). Sample: Bile acid receptor, 17-beta-hydroxysteroid dehydrogenase 13.

Bioactivity

ChEMBL activities: 5 potent at pChembl ≥ 5 of 5 total. Top 30 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
NR1H47.82EC5015nMCHEMBL_ACT_19005356
NR1H47.4EC5040nMCHEMBL_ACT_26335959
NR1H47.39EC5041nMCHEMBL_ACT_19005357
NR1H47.24EC5058nMCHEMBL_ACT_29190970
HSD17B135.02IC509470nMCHEMBL_ACT_29190945

Target pathways

Aggregated over 2 target gene(s): EPHA2, NR1H4.

Top Reactome pathways

20 total, by targets touching each:

PathwayTargetsGenes
Recycling of bile acids and salts1NR1H4
Synthesis of bile acids and bile salts1NR1H4
Synthesis of bile acids and bile salts via 7alpha-hydroxycholesterol1NR1H4
Synthesis of bile acids and bile salts via 27-hydroxycholesterol1NR1H4
PPARA activates gene expression1NR1H4
Endogenous sterols1NR1H4
EPH-Ephrin signaling1EPHA2
Nuclear Receptor transcription pathway1NR1H4
EPHA-mediated growth cone collapse1EPHA2
EPH-ephrin mediated repulsion of cells1EPHA2
SUMOylation of intracellular receptors1NR1H4
RAC1 GTPase cycle1EPHA2
RAC2 GTPase cycle1EPHA2
RHOG GTPase cycle1EPHA2
RHOU GTPase cycle1EPHA2
RAC3 GTPase cycle1EPHA2
RHOV GTPase cycle1EPHA2
RND3 GTPase cycle1EPHA2
RND2 GTPase cycle1EPHA2
RND1 GTPase cycle1EPHA2

Dominant GO biological processes

GO termTargets
inflammatory response2
cell differentiation2
skeletal system development1
angiogenesis1
vasculogenesis1
osteoblast differentiation1
blood vessel endothelial cell proliferation involved in sprouting angiogenesis1
cell adhesion1
cell surface receptor protein tyrosine kinase signaling pathway1
intrinsic apoptotic signaling pathway in response to DNA damage1
regulation of lamellipodium assembly1
notochord formation1
cell migration1
negative regulation of angiogenesis1
neural tube development1

Indications & clinical

Indications

4 indications (0 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

IndicationTrial phaseMONDOEFO
sclerosing cholangitis3MONDO:0018646EFO:0004268
metabolic dysfunction-associated steatohepatitis2MONDO:0007027EFO:1001249
primary biliary cholangitis2MONDO:0005388EFO:1001486
metabolic dysfunction-associated steatotic liver disease2MONDO:0013209EFO:0003095

Clinical trials

Total trials: 9.

Phase distribution

PhaseTrials
PHASE25
PHASE13
PHASE31

Top trials by phase / activity

NCTPhaseStatusTitle
NCT03890120PHASE3TERMINATEDStudy of Cilofexor in Adults With Primary Sclerosing Cholangitis
NCT01999101PHASE2COMPLETEDSafety Pilot Study of Farnesoid X Receptor (FXR) Agonist in Non-alcoholic Fatty Liver Disease (NAFLD) Patients
NCT02854605PHASE2COMPLETEDEvaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT02943447PHASE2TERMINATEDStudy to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
NCT02943460PHASE2COMPLETEDStudy to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Sclerosing Cholangitis Without Cirrhosis
NCT03987074PHASE2COMPLETEDSafety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT02654002PHASE1COMPLETEDStudy in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
NCT02808312PHASE1COMPLETEDPharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
NCT04060147PHASE1TERMINATEDSafety and Tolerability of Cilofexor in Participants With Primary Sclerosing Cholangitis (PSC) and Compensated Cirrhosis

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Molecules sharing ≥1 of this drug’s curated primary targets, merged from two biobtree sources and ranked by shared-target count, then clinical phase: ChEMBL clinical-stage candidates (development phase ≥2) and PubChem drug-class bioactivity (approved / known drugs acting on the target). Deduplicated by drug name; the drug’s own salt forms are excluded. Note: for a drug with few primary targets a shared-target match can reflect off-target / promiscuous binding rather than the same therapeutic mechanism — the phase ordering surfaces bona-fide therapeutics first.

90 molecules share ≥1 primary target. Top 60 by shared-target count:

MoleculeSourceStatusShared targets
REGORAFENIBChEMBL + PubChemPhase 4 (approved)EPHA2, NR1H4
CHENODIOLChEMBL + PubChemPhase 4 (approved)NR1H4
CRIZOTINIBChEMBL + PubChemPhase 4 (approved)EPHA2
FEDRATINIBChEMBL + PubChemPhase 4 (approved)EPHA2
FULVESTRANTChEMBL + PubChemPhase 4 (approved)NR1H4
ACETAMINOPHENChEMBLPhase 4 (approved)NR1H4
ATORVASTATINChEMBLPhase 4 (approved)NR1H4
BENZBROMARONEChEMBLPhase 4 (approved)NR1H4
BOSUTINIBChEMBLPhase 4 (approved)EPHA2
CABOZANTINIBChEMBLPhase 4 (approved)EPHA2
CHOLIC ACIDChEMBLPhase 4 (approved)NR1H4
CLOFAZIMINEChEMBLPhase 4 (approved)NR1H4
CLOTRIMAZOLEChEMBLPhase 4 (approved)NR1H4
CYCLOSPORINEChEMBLPhase 4 (approved)NR1H4
DASATINIBChEMBLPhase 4 (approved)EPHA2
DEOXYCHOLIC ACIDChEMBLPhase 4 (approved)NR1H4
DICLOFENACChEMBLPhase 4 (approved)NR1H4
EPALRESTATChEMBLPhase 4 (approved)NR1H4
FELODIPINEChEMBLPhase 4 (approved)NR1H4
FLUTRIMAZOLEChEMBLPhase 4 (approved)NR1H4
IVERMECTINChEMBLPhase 4 (approved)NR1H4
KETOCONAZOLEChEMBLPhase 4 (approved)NR1H4
LEVOTHYROXINEChEMBLPhase 4 (approved)NR1H4
LORATADINEChEMBLPhase 4 (approved)NR1H4
NILOTINIBChEMBLPhase 4 (approved)EPHA2
NIMODIPINEChEMBLPhase 4 (approved)NR1H4
NINTEDANIBChEMBLPhase 4 (approved)EPHA2
OBETICHOLIC ACIDChEMBLPhase 4 (approved)NR1H4
ODEVIXIBATChEMBLPhase 4 (approved)NR1H4
PONATINIBChEMBLPhase 4 (approved)EPHA2
PRANLUKASTChEMBLPhase 4 (approved)NR1H4
RALOXIFENEChEMBLPhase 4 (approved)NR1H4
REPAGLINIDEChEMBLPhase 4 (approved)NR1H4
RIMONABANTChEMBLPhase 4 (approved)NR1H4
SIMVASTATINChEMBLPhase 4 (approved)NR1H4
SORAFENIBChEMBLPhase 4 (approved)EPHA2
SULCONAZOLEChEMBLPhase 4 (approved)NR1H4
SUNITINIBChEMBLPhase 4 (approved)NR1H4
TAURURSODIOLChEMBLPhase 4 (approved)NR1H4
TIVOZANIBChEMBLPhase 4 (approved)EPHA2
TOVORAFENIBChEMBLPhase 4 (approved)EPHA2
TROGLITAZONEChEMBLPhase 4 (approved)NR1H4
VANDETANIBChEMBLPhase 4 (approved)EPHA2
ZAFIRLUKASTChEMBLPhase 4 (approved)NR1H4
ALISERTIBChEMBLPhase 3EPHA2
ALVOCIDIBChEMBLPhase 3EPHA2
ANDROGRAPHOLIDEChEMBLPhase 3NR1H4
ELOBIXIBATChEMBLPhase 3NR1H4
LESTAURTINIBChEMBLPhase 3EPHA2
LINIFANIBChEMBLPhase 3EPHA2
SARACATINIBChEMBLPhase 3EPHA2
TESEVATINIBChEMBLPhase 3EPHA2
VIDOFLUDIMUSChEMBLPhase 3NR1H4
AT-9283ChEMBLPhase 2EPHA2
BAFETINIBChEMBLPhase 2EPHA2
BMS-754807ChEMBLPhase 2EPHA2
CEP-32496ChEMBLPhase 2EPHA2
DANUSERTIBChEMBLPhase 2EPHA2
DORAMAPIMODChEMBLPhase 2EPHA2
FORETINIBChEMBLPhase 2EPHA2