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flibanserin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| serotonin receptor antagonists (mostly 5-HT2) | 5022 | 167933-07-5 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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
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 |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 4.053 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.865 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 43.954 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 17.783 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 1.140 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 3.280 | % | High | 1 |
| herg | hERG pIC50 | 5.274 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 31.189 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 107.647 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 1.090 | % | High | 1 |
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.247 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 75.336 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 1.590 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 4.207 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 | |||
| pppb | Pig plasma protein binding (% unbound) | 3.210 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 136.773 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 13.200 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 1.420 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 13.900 | uM | High | 1 |
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 | 80.37 | 51.92 | 16 | 153 | 21864 | 90606414 |
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 | 139.40 | 118.47 | 15 | 7 | 1552 | 42619761 |
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 | 137.73 | 51.77 | 18 | 100 | 3180 | 110586001 |
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 | antidepressant |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35941 | serotonergic agonist |
| CHEBI has role | CHEBI:48279 | serotonergic antagonist |
Related Drugs by ATC class:
G02CX Other gynecologicals 4 drugs
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 | 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)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 100MG | ADDYI | SPROUT PHARMS | N022526 | Aug. 18, 2015 | RX | TABLET | ORAL | Dec. 13, 2028 | REVISION TO THE INDICATION TO INCLUDE WOMEN LESS THAN 65 YEARS OF AGE INDEPENDENT OF REPRODUCTIVE STATUS |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| 5-hydroxytryptamine receptor 1A | GPCR | AGONIST | Ki | 9 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| 5-hydroxytryptamine receptor 2A | GPCR | ANTAGONIST | Ki | 7.31 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| D(3) dopamine receptor | GPCR | Ki | 6.44 | SCIENTIFIC LITERATURE | |||||
| D(4) dopamine receptor | GPCR | ANTAGONIST | Ki | 8.40 | SCIENTIFIC LITERATURE | ||||
| 5-hydroxytryptamine receptor 2C | GPCR | ANTAGONIST | Ki | 7.05 | SCIENTIFIC LITERATURE | ||||
| 5-hydroxytryptamine receptor 5A | GPCR | Ki | 6.09 | SCIENTIFIC LITERATURE | |||||
| 5-hydroxytryptamine receptor 2B | GPCR | ANTAGONIST | Ki | 7.05 | SCIENTIFIC LITERATURE | ||||
| D(2) dopamine receptor | GPCR | Ki | 6.52 | SCIENTIFIC LITERATURE | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | 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 |
| 37JK4STR6Z | INXIGHT DRUGS |
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 |