Flibanserin

drug
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Also known as AddyiBIMT 17BIMT 17 BSBIMT-17EctrisFlibanserinaFlibanserine

Summary

Flibanserin (CHEMBL231068) is an approved small-molecule serotonergic agonist (ATC G02CX02) targeting HTR1A and HTR2A; indicated across 3 conditions including mental disorder and prostate adenocarcinoma.

At a glance

  • Status: Approved (max clinical phase 4)
  • Modality: Small molecule
  • ATC class: G02CX02
  • Targets: 2 (HTR1A, HTR2A)
  • Indications: 3 conditions
  • Clinical trials: 14
  • Chemistry: 390.4 Da · C20H21F3N4O

Identifiers

Drug identity and classification

FieldValue
ChEMBL IDCHEMBL231068
NameFlibanserin
TypeSmall molecule
Max phase4
FDA approvedyes
PubChem CID6918248
ChEBICHEBI:90865
ATCG02CX02
Molecular formulaC20H21F3N4O
Molecular weight390.4
InChIKeyPPRRDFIXUUSXRA-UHFFFAOYSA-N

SMILES: C1CN(CCN1CCN2C3=CC=CC=C3NC2=O)C4=CC=CC(=C4)C(F)(F)F

IUPAC name: 3-[2-[4-[3-(trifluoromethyl)phenyl]piperazin-1-yl]ethyl]-1H-benzimidazol-2-one

ChEBI definition: An N-alkylpiperazine that is 1-[2-(1,3-dihydro-2-oxobenzimidazol-1-yl)ethyl]piperazine in which the remaining amino proton is replaced by a 3-(trifluoromethyl)phenyl group. A multifunctional serotonin agonist and antagonist which is used for the treatment of pre-menopausal women with hypoactive sexual desire disorder.

Pharmacological roles (ChEBI): serotonergic agonist, serotonergic antagonist, antidepressant.

Also known as: Addyi, BIMT 17, BIMT 17 BS, BIMT-17, Ectris, Flibanserin, Flibanserina, Flibanserine, FLIBANSERIN, flibanserin

Patent coverage: 501 distinct patent families (1,629 SureChEMBL compound mentions), from 3 matched compound structure(s). One matched structure accounts for 1,556 (96%) 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
HTR1A5-HT1A receptorAgonist90%P08908
HTR2A5-HT2A receptorAntagonist7.310%P28223

Broader ChEMBL bioactivity targets: 14 (assay-derived). Sample: Alpha-2A adrenergic receptor, D(1A) dopamine receptor, Thromboxane A2 receptor, 5-hydroxytryptamine receptor 1A, Muscarinic acetylcholine receptor M1, Sodium-dependent serotonin transporter, Alpha-1A adrenergic receptor, Mu-type opioid receptor, D(3) dopamine receptor, Voltage-gated inwardly rectifying potassium channel KCNH2, Adenosine receptor A3, 5-hydroxytryptamine receptor 1A, Synaptic vesicular amine transporter, Bile salt export pump.

Bioactivity

ChEMBL activities: 10 potent at pChembl ≥ 5 of 16 total. Top 100 by potency (10 = 0.1 nM, 6 = 1 µM):

TargetpChemblTypeValueUnitActivity ID
HTR1A8.52AC503nMCHEMBL_ACT_25165107
P193277.93Ki11.75nMCHEMBL_ACT_1924326
HTR1A7.93Ki11.8nMCHEMBL_ACT_24911828
Q018277.14AC5072nMCHEMBL_ACT_25197368
DRD36.54AC50286nMCHEMBL_ACT_25194605
ADRA1A6.41AC50391.2nMCHEMBL_ACT_25218920
HTR1A6.2EC50631nMCHEMBL_ACT_1924417
OPRM15.88AC501305nMCHEMBL_ACT_25158258
DRD15.61AC502435nMCHEMBL_ACT_25115293
CHRM15AC5010100nMCHEMBL_ACT_25209451

Target pathways

Aggregated over 2 target gene(s): HTR1A, HTR2A.

Top Reactome pathways

8 total, by targets touching each:

PathwayTargetsGenes
Signal Transduction2HTR1A, HTR2A
Signaling by GPCR2HTR1A, HTR2A
Class A/1 (Rhodopsin-like receptors)2HTR1A, HTR2A
Amine ligand-binding receptors2HTR1A, HTR2A
Serotonin receptors2HTR1A, HTR2A
GPCR ligand binding2HTR1A, HTR2A
GPCR downstream signalling1HTR2A
G alpha (q) signalling events1HTR2A

Dominant GO biological processes

GO termTargets
G protein-coupled receptor signaling pathway2
G protein-coupled receptor signaling pathway, coupled to cyclic nucleotide second messenger2
serotonin receptor signaling pathway2
chemical synaptic transmission2
positive regulation of cell population proliferation2
signal transduction2
G protein-coupled serotonin receptor signaling pathway2
behavioral fear response1
adenylate cyclase-inhibiting serotonin receptor signaling pathway1
gamma-aminobutyric acid signaling pathway1
regulation of serotonin secretion1
regulation of vasoconstriction1
adult behavior1
exploration behavior1
regulation of dopamine metabolic process1

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

IndicationPhaseMONDOEFO
mental disorder4MONDO:0005084EFO:0000677

1 disease in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)PhaseMONDOEFO
prostate adenocarcinoma2MONDO:0005082EFO:0000673

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 14.

Phase distribution

PhaseTrials
PHASE39
PHASE23
PHASE41
Not specified1

Top trials by phase / activity

NCTPhaseStatusTitle
NCT02714049PHASE4TERMINATEDFlibanserin (Addyi®) vs. Flibanserin and Sex Therapy
NCT00277914PHASE3COMPLETEDFlibanserin Randomized Withdrawal Trial in Pre-menopausal Women
NCT00360243PHASE3COMPLETED6-mo. Min Eff Dose of Flibanserin: 25 v 50 mg Bid v 50 mg hs v Pbo in Younger Women in NA
NCT00360529PHASE3COMPLETED24-week Placebo-controlled Trial of Flibanserin Once Daily in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT00360555PHASE3COMPLETEDUptitration Trial of Flibanserin Versus Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT00441558PHASE3TERMINATEDA One-year Safety Study of Flibanserin to Treat Pre-Menopausal Women With Hypoactive Sexual Desire Disorder (HSDD).
NCT00996164PHASE3COMPLETEDFixed 100 mg Every Evening of Flibanserin vs Placebo in Premenopausal Women With Hypoactive Sexual Desire Disorder
NCT00996372PHASE3COMPLETEDFlibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women
NCT01057901PHASE3TERMINATEDFlibanserin for the Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women in North America
NCT01103362PHASE3TERMINATEDA 28-week Safety Study of Flibanserin in Pre- and Postmenopausal Women With Hypoactive Sexual Desire Disorder
NCT03707340PHASE2ACTIVE_NOT_RECRUITINGA Study of Flibanserin in Breast Cancer Survivors on Tamoxifen or Aromatase Inhibitors
NCT04743934PHASE2ACTIVE_NOT_RECRUITINGFlibanserin in Men Receiving Androgen Suppression for Prostate Cancer
NCT04002661PHASE2TERMINATEDHypoactive Sexual Desire Disorder in Males
NCT02770768Not specifiedTERMINATEDEffects of Flibanserin on the Pre- and Post-menopausal Female Brain

Clinical evidence (CIViC)

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

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

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.

593 molecules share ≥1 primary target. Top 100 by shared-target count:

MoleculeSourceStatusShared targets
DIHYDROERGOTAMINEChEMBL + PubChemPhase 4 (approved)HTR1A, HTR2A
FidaxomicinChEMBL + PubChemPhase 4 (approved)HTR1A, HTR2A
PimavanserinChEMBL + PubChemPhase 4 (approved)HTR1A, HTR2A
PropoxypheneChEMBL + PubChemPhase 4 (approved)HTR1A, HTR2A
REGORAFENIBChEMBL + PubChemPhase 4 (approved)HTR1A, HTR2A
ACETOPHENAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
ALMOTRIPTANChEMBLPhase 4 (approved)HTR1A, HTR2A
AMITRIPTYLINEChEMBLPhase 4 (approved)HTR1A, HTR2A
AMLODIPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
AMOXAPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
APOMORPHINEChEMBLPhase 4 (approved)HTR1A, HTR2A
ARIPIPRAZOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
ASENAPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
ASTEMIZOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
AZATADINEChEMBLPhase 4 (approved)HTR1A, HTR2A
BAZEDOXIFENEChEMBLPhase 4 (approved)HTR1A, HTR2A
BEDAQUILINEChEMBLPhase 4 (approved)HTR1A, HTR2A
BENFLUOREXChEMBLPhase 4 (approved)HTR1A, HTR2A
BENPERIDOLChEMBLPhase 4 (approved)HTR1A, HTR2A
BOSUTINIBChEMBLPhase 4 (approved)HTR1A, HTR2A
BREXPIPRAZOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
BROMOCRIPTINEChEMBLPhase 4 (approved)HTR1A, HTR2A
BROMPERIDOLChEMBLPhase 4 (approved)HTR1A, HTR2A
BUSPIRONEChEMBLPhase 4 (approved)HTR1A, HTR2A
CABERGOLINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CANDESARTAN CILEXETILChEMBLPhase 4 (approved)HTR1A, HTR2A
CANNABIDIOLChEMBLPhase 4 (approved)HTR1A, HTR2A
CARBENOXOLONEChEMBLPhase 4 (approved)HTR1A, HTR2A
CARIPRAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CARVEDILOLChEMBLPhase 4 (approved)HTR1A, HTR2A
CHLORHEXIDINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CHLORPROMAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CINACALCETChEMBLPhase 4 (approved)HTR1A, HTR2A
CINNARIZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CISAPRIDEChEMBLPhase 4 (approved)HTR1A, HTR2A
CITALOPRAMChEMBLPhase 4 (approved)HTR1A, HTR2A
CLEMASTINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CLOMIPRAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CLONIDINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CLOZAPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CYCLOBENZAPRINEChEMBLPhase 4 (approved)HTR1A, HTR2A
CYPROHEPTADINEChEMBLPhase 4 (approved)HTR1A, HTR2A
DAPIPRAZOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
DASATINIBChEMBLPhase 4 (approved)HTR1A, HTR2A
DESLORATADINEChEMBLPhase 4 (approved)HTR1A, HTR2A
DEXCHLORPHENIRAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
DIBENZEPINChEMBLPhase 4 (approved)HTR1A, HTR2A
DIPHENIDOLChEMBLPhase 4 (approved)HTR1A, HTR2A
DOMPERIDONEChEMBLPhase 4 (approved)HTR1A, HTR2A
DOXAZOSINChEMBLPhase 4 (approved)HTR1A, HTR2A
DOXEPINChEMBLPhase 4 (approved)HTR1A, HTR2A
DULOXETINEChEMBLPhase 4 (approved)HTR1A, HTR2A
EBASTINEChEMBLPhase 4 (approved)HTR1A, HTR2A
ERGOTAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
FLUPHENAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
GENTIAN VIOLETChEMBLPhase 4 (approved)HTR1A, HTR2A
GEPIRONEChEMBLPhase 4 (approved)HTR1A, HTR2A
GUANABENZChEMBLPhase 4 (approved)HTR1A, HTR2A
GUANFACINEChEMBLPhase 4 (approved)HTR1A, HTR2A
HALOPERIDOLChEMBLPhase 4 (approved)HTR1A, HTR2A
ILOPERIDONEChEMBLPhase 4 (approved)HTR1A, HTR2A
IMIPRAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
IPRINDOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
KETANSERINChEMBLPhase 4 (approved)HTR1A, HTR2A
LEFLUNOMIDEChEMBLPhase 4 (approved)HTR1A, HTR2A
LETERMOVIRChEMBLPhase 4 (approved)HTR1A, HTR2A
LORCASERINChEMBLPhase 4 (approved)HTR1A, HTR2A
LOXAPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
LUMATEPERONE TOSYLATEChEMBLPhase 4 (approved)HTR1A, HTR2A
LURASIDONEChEMBLPhase 4 (approved)HTR1A, HTR2A
MAPROTILINEChEMBLPhase 4 (approved)HTR1A, HTR2A
MEBEVERINEChEMBLPhase 4 (approved)HTR1A, HTR2A
MEFLOQUINEChEMBLPhase 4 (approved)HTR1A, HTR2A
METHYLERGONOVINEChEMBLPhase 4 (approved)HTR1A, HTR2A
METHYSERGIDEChEMBLPhase 4 (approved)HTR1A, HTR2A
MIANSERINChEMBLPhase 4 (approved)HTR1A, HTR2A
MIRTAZAPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
NAFTOPIDILChEMBLPhase 4 (approved)HTR1A, HTR2A
NEBIVOLOLChEMBLPhase 4 (approved)HTR1A, HTR2A
NEFAZODONEChEMBLPhase 4 (approved)HTR1A, HTR2A
NORTRIPTYLINEChEMBLPhase 4 (approved)HTR1A, HTR2A
OLANZAPINEChEMBLPhase 4 (approved)HTR1A, HTR2A
OLODATEROLChEMBLPhase 4 (approved)HTR1A, HTR2A
OSIMERTINIBChEMBLPhase 4 (approved)HTR1A, HTR2A
OXICONAZOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
OXPRENOLOLChEMBLPhase 4 (approved)HTR1A, HTR2A
OXYMETAZOLINEChEMBLPhase 4 (approved)HTR1A, HTR2A
OXYPERTINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PAROXETINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PASIREOTIDEChEMBLPhase 4 (approved)HTR1A, HTR2A
PERGOLIDEChEMBLPhase 4 (approved)HTR1A, HTR2A
PERHEXILINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PERPHENAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PHENOXYBENZAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PHENTOLAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PIMOZIDEChEMBLPhase 4 (approved)HTR1A, HTR2A
PIPERACETAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PRAMIPEXOLEChEMBLPhase 4 (approved)HTR1A, HTR2A
PRENYLAMINEChEMBLPhase 4 (approved)HTR1A, HTR2A
PROCHLORPERAZINEChEMBLPhase 4 (approved)HTR1A, HTR2A