All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

flibanserin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
serotonin receptor antagonists (mostly 5-HT2)	5022	167933-07-5

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: flibanserin addyi ectris BIMT-17 BIMT 17

a serotonin receptor modulator with high affinity for the following serotonin (5-hydroxytryptamine or 5-T) receptors: agonist activity at 5-HT1A and antagonist activity at 5-HT2A. Flibanserin also has moderate antagonist activities at the 5-HT2B, 5-HT2C, and dopamine D4 receptors, used in the treatment of premenopausal women with hypoactive sexual desire disorder Molecular weight: 390.41 Formula: C20H21F3N4O CLOGP: 4.09 LIPINSKI: 0 HAC: 5 HDO: 1 TPSA: 38.82 ALOGS: -3.34 ROTB: 5 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
S (Water solubility)	0.00 mg/mL	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
Aug. 18, 2015	FDA	SPROUT PHARMACEUTICALS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Therapeutic response unexpected	83.97	70.32	16	97	18743	63470166

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Accidental exposure to product by child	137.33	116.91	15	7	1461	34955448

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Accidental exposure to product by child	141.18	69.76	18	62	2908	79741400

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	G02CX02	GENITO URINARY SYSTEM AND SEX HORMONES OTHER GYNECOLOGICALS OTHER GYNECOLOGICALS Other gynecologicals
FDA MoA	N0000185503	P-Glycoprotein Inhibitors
CHEBI has role	CHEBI:35469	antidepressants
CHEBI has role	CHEBI:35941	serotonin agonists
CHEBI has role	CHEBI:48279	serotonin antagonists

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Lack or loss of sexual desire	indication	270903007	DOID:13868
Decreased liver function	contraindication	77981007

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	10.37	acidic
pKa2	6.88	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
100MG	ADDYI	SPROUT PHARMS	N022526	Aug. 18, 2015	RX	TABLET	ORAL	8227471	May 9, 2023	USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)
100MG	ADDYI	SPROUT PHARMS	N022526	Aug. 18, 2015	RX	TABLET	ORAL	7151103	May 9, 2028	USE OF FLIBANSERIN OR A PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALT THEREOF TO TREAT HYPOACTIVE SEXUAL DESIRE DISORDER (HSDD)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN	AGONIST	Ki	9		SCIENTIFIC LITERATURE	DRUG LABEL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	7.31		SCIENTIFIC LITERATURE	DRUG LABEL
D(3) dopamine receptor	GPCR	P35462	DRD3_HUMAN		Ki	6.44		SCIENTIFIC LITERATURE
D(4) dopamine receptor	GPCR	P21917	DRD4_HUMAN	ANTAGONIST	Ki	8.40		SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 2C	GPCR	P28335	5HT2C_HUMAN	ANTAGONIST	Ki	7.05		SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 5A	GPCR	P47898	5HT5A_HUMAN		Ki	6.09		SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 2B	GPCR	P41595	5HT2B_HUMAN	ANTAGONIST	Ki	7.05		SCIENTIFIC LITERATURE
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN		Ki	6.52		SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT		Ki	7.93		CHEMBL

External reference:

ID	Source
D02577	KEGG_DRUG
4034860	VANDF
CHEBI:90865	CHEBI
CHEMBL231068	ChEMBL_ID
C098107	MESH_SUPPLEMENTAL_RECORD_UI
8182	IUPHAR_LIGAND_ID
DB04908	DRUGBANK_ID
1665509	RXNORM
235672	MMSL
31149	MMSL
d08377	MMSL
016419	NDDF
715253002	SNOMEDCT_US
763581005	SNOMEDCT_US
C0754280	UMLSCUI
7512	INN_ID
6918248	PUBCHEM_CID
37JK4STR6Z	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
ADDYI	HUMAN PRESCRIPTION DRUG LABEL	1	58604-214	TABLET, FILM COATED	100 mg	ORAL	NDA	27 sections