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

Stem definitionDrug idCAS RN
4223 163521-12-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vilazodone
  • viibryd
  • vilazodone hydrochloride
  • vilazodone HCl
A benzofuran, indole, and piperazine derivative that functions as a SEROTONIN UPTAKE INHIBITOR and partial SEROTONIN 5-HT1 RECEPTOR AGONIST. It is used as an ANTIDEPRESSIVE AGENT.
  • Molecular weight: 441.54
  • Formula: C26H27N5O2
  • CLOGP: 4.33
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 2
  • TPSA: 102.29
  • ALOGS: -3.56
  • ROTB: 7

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 4.85 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.76 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.03 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 15.66 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 2011 FDA FOREST LABS LLC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Suicidal ideation 248.42 20.51 119 5489 57623 56228836
Abnormal dreams 140.87 20.51 48 5560 9601 56276858
Hallucination 124.16 20.51 71 5537 49078 56237381
Persistent genital arousal disorder 95.78 20.51 18 5590 308 56286151
Anxiety 94.78 20.51 106 5502 193066 56093393
Depression 93.83 20.51 102 5506 180015 56106444
Serotonin syndrome 91.16 20.51 47 5561 26443 56260016
Nightmare 79.28 20.51 37 5571 16789 56269670
Agitation 74.34 20.51 54 5554 55982 56230477
Sleep paralysis 74.31 20.51 16 5592 555 56285904
Paraesthesia 69.78 20.51 75 5533 130439 56156020
Mania 65.88 20.51 29 5579 11491 56274968
Insomnia 58.36 20.51 83 5525 191777 56094682
Suicide attempt 47.31 20.51 42 5566 57794 56228665
Feeling abnormal 46.92 20.51 62 5546 133540 56152919
Anger 46.85 20.51 23 5585 11649 56274810
Crying 46.25 20.51 28 5580 21412 56265047
Completed suicide 45.30 20.51 61 5547 133772 56152687
Tremor 43.76 20.51 57 5551 121032 56165427
Dizziness 43.18 20.51 107 5501 376033 55910426
Seizure 40.77 20.51 56 5552 125063 56161396
Irritability 40.31 20.51 29 5579 29559 56256900
Muscle twitching 31.94 20.51 20 5588 16222 56270237
Panic attack 30.06 20.51 21 5587 20426 56266033
Tardive dyskinesia 29.79 20.51 15 5593 8016 56278443
Withdrawal syndrome 29.60 20.51 20 5588 18442 56268017
Sleep terror 29.41 20.51 8 5600 748 56285711
Obsessive-compulsive disorder 26.72 20.51 11 5597 3695 56282764
Nausea 24.33 20.51 144 5464 764034 55522425
Hypnagogic hallucination 24.22 20.51 5 5603 141 56286318
Diarrhoea 23.39 20.51 125 5483 638382 55648077
Homeless 20.93 20.51 4 5604 75 56286384

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Suicidal ideation 141.66 33.64 60 1848 36346 31659090
Serotonin syndrome 141.25 33.64 50 1858 18723 31676713
Completed suicide 92.00 33.64 61 1847 91453 31603983
Mania 52.44 33.64 20 1888 9157 31686279
Anxiety 49.37 33.64 42 1866 90991 31604445
Sexual dysfunction 49.00 33.64 17 1891 5951 31689485
Overdose 35.84 33.64 34 1874 84630 31610806

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Suicidal ideation 208.61 22.03 102 5147 69494 70853701
Serotonin syndrome 138.99 22.03 66 5183 42048 70881147
Completed suicide 108.64 22.03 107 5142 227028 70696167
Persistent genital arousal disorder 94.80 22.03 17 5232 304 70922891
Anxiety 91.11 22.03 96 5153 220234 70702961
Abnormal dreams 87.54 22.03 32 5217 10571 70912624
Depression 77.45 22.03 84 5165 198890 70724305
Hallucination 69.33 22.03 52 5197 76208 70846987
Mania 63.04 22.03 29 5220 17145 70906050
Nightmare 56.02 22.03 29 5220 22127 70901068
Sleep paralysis 55.03 22.03 12 5237 599 70922596
Paraesthesia 52.34 22.03 59 5190 145478 70777717
Anger 52.29 22.03 25 5224 16107 70907088
Insomnia 50.68 22.03 71 5178 217735 70705460
Tremor 49.12 22.03 59 5190 155565 70767630
Crying 48.63 22.03 26 5223 21173 70902022
Irritability 46.12 22.03 31 5218 38194 70885001
Agitation 40.82 22.03 42 5207 93333 70829862
Intentional overdose 38.98 22.03 42 5207 98393 70824802
Suicide attempt 38.87 22.03 38 5211 79472 70843723
Muscle twitching 33.75 22.03 20 5229 19807 70903388
Feeling abnormal 31.00 22.03 45 5204 142274 70780921
Off label use 30.64 22.03 122 5127 742938 70180257
Memory impairment 28.99 22.03 35 5214 92606 70830589
Obsessive-compulsive disorder 25.94 22.03 11 5238 5359 70917836
Dizziness 25.70 22.03 84 5165 464057 70459138
Tardive dyskinesia 25.10 22.03 13 5236 9916 70913279
Seizure 22.34 22.03 44 5205 177918 70745277
Panic attack 22.13 22.03 16 5233 22103 70901092

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AX24 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D000928 Antidepressive Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D011619 Psychotropic Drugs
MeSH PA D058825 Serotonin 5-HT1 Receptor Agonists
MeSH PA D018490 Serotonin Agents
MeSH PA D017366 Serotonin Receptor Agonists
MeSH PA D017367 Serotonin Uptake Inhibitors
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35941 serotonin agonists
CHEBI has role CHEBI:50949 SSRI

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

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Suicidal thoughts contraindication 6471006
Bipolar disorder contraindication 13746004 DOID:3312
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Blood coagulation disorder contraindication 64779008 DOID:1247
Hyponatremia contraindication 89627008
Seizure disorder contraindication 128613002
Suicidal contraindication 267073005
Serotonin syndrome contraindication 371089000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.56 acidic
pKa2 13.13 acidic
pKa3 8.58 Basic
pKa4 1.41 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 7834020 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
10MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 8193195 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
10MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 8236804 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
20MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 7834020 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
20MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 8193195 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
20MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 8236804 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
40MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 7834020 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
40MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 8193195 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
40MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL 8236804 June 5, 2022 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL Jan. 31, 2023 INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS AGES 7 TO 17 YEARS OF AGE WITH MAJOR DEPRESSIVE DISORDER
20MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL Jan. 31, 2023 INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS AGES 7 TO 17 YEARS OF AGE WITH MAJOR DEPRESSIVE DISORDER
40MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL Jan. 31, 2023 INFORMATION ADDED TO THE LABELING REGARDING PEDIATRIC PATIENTS AGES 7 TO 17 YEARS OF AGE WITH MAJOR DEPRESSIVE DISORDER
10MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL July 31, 2023 PEDIATRIC EXCLUSIVITY
20MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL July 31, 2023 PEDIATRIC EXCLUSIVITY
40MG VIIBRYD ALLERGAN N022567 Jan. 21, 2011 RX TABLET ORAL July 31, 2023 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR IC50 9.30 IUPHAR CHEMBL
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 9.70 IUPHAR CHEMBL
D(3) dopamine receptor GPCR AGONIST IC50 7.15 IUPHAR
Histamine H1 receptor GPCR AGONIST IC50 6.50 IUPHAR
5-hydroxytryptamine receptor 4 GPCR AGONIST IC50 6.60 IUPHAR
Adrenergic receptor alpha-2 GPCR IC50 5.22 CHEMBL
D(2) dopamine receptor GPCR AGONIST IC50 6.18 IUPHAR
Adrenergic receptor alpha-1 GPCR IC50 5.70 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 5.41 CHEMBL
5-hydroxytryptamine receptor 1B GPCR IC50 5.30 CHEMBL
D(2) dopamine receptor GPCR IC50 6.18 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 9.52 CHEMBL
Sodium-dependent serotonin transporter Transporter IC50 9.30 CHEMBL
5-hydroxytryptamine receptor 2A GPCR IC50 5.82 CHEMBL
5-hydroxytryptamine receptor 7 GPCR IC50 5.52 CHEMBL
Acetylcholinesterase Enzyme IC50 4.67 CHEMBL
5-hydroxytryptamine receptor 2C GPCR IC50 5.70 CHEMBL
5-hydroxytryptamine receptor 4 GPCR IC50 6.60 CHEMBL
D(3) dopamine receptor GPCR IC50 7.15 CHEMBL
5-hydroxytryptamine receptor 1D GPCR IC50 5.40 CHEMBL
D(4) dopamine receptor GPCR IC50 5.47 CHEMBL
5-hydroxytryptamine receptor 6 GPCR IC50 5.52 CHEMBL
Serotonin 3 (5-HT3) receptor Ion channel IC50 5.37 CHEMBL

External reference:

IDSource
4030483 VUID
N0000182438 NUI
D09698 KEGG_DRUG
163521-08-2 SECONDARY_CAS_RN
4030483 VANDF
4030484 VANDF
C1530072 UMLSCUI
CHEBI:70707 CHEBI
YG7 PDB_CHEM_ID
CHEMBL439849 ChEMBL_ID
CHEMBL1615374 ChEMBL_ID
D000069503 MESH_DESCRIPTOR_UI
DB06684 DRUGBANK_ID
7427 IUPHAR_LIGAND_ID
7638 INN_ID
S239O2OOV3 UNII
6918314 PUBCHEM_CID
1086768 RXNORM
179494 MMSL
27744 MMSL
359491 MMSL
d07740 MMSL
013753 NDDF
013754 NDDF
702837008 SNOMEDCT_US
702838003 SNOMEDCT_US
715638004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
VIIBRYD HUMAN PRESCRIPTION DRUG LABEL 1 0456-1110 TABLET 10 mg ORAL NDA 32 sections
VIIBRYD HUMAN PRESCRIPTION DRUG LABEL 1 0456-1120 TABLET 20 mg ORAL NDA 32 sections
VIIBRYD HUMAN PRESCRIPTION DRUG LABEL 1 0456-1140 TABLET 40 mg ORAL NDA 32 sections
Vilazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0480-2043 TABLET, FILM COATED 40 mg ORAL ANDA 29 sections
Vilazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0480-2044 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
Vilazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0480-2045 TABLET, FILM COATED 10 mg ORAL ANDA 29 sections
Vilazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-352 TABLET 10 mg ORAL ANDA 32 sections
Vilazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-353 TABLET 20 mg ORAL ANDA 32 sections
Vilazodone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-354 TABLET 40 mg ORAL ANDA 32 sections
vilazodone HUMAN PRESCRIPTION DRUG LABEL 1 51407-691 TABLET 10 mg ORAL NDA authorized generic 31 sections
Vilazodone HUMAN PRESCRIPTION DRUG LABEL 1 51407-692 TABLET 20 mg ORAL NDA authorized generic 31 sections
Vilazodone HUMAN PRESCRIPTION DRUG LABEL 1 51407-693 TABLET 40 mg ORAL NDA authorized generic 31 sections
VIIBRYD HUMAN PRESCRIPTION DRUG LABEL 1 55154-4624 TABLET 40 mg ORAL NDA 29 sections
VIIBRYD HUMAN PRESCRIPTION DRUG LABEL 1 55154-4627 TABLET 20 mg ORAL NDA 29 sections
vilazodone HUMAN PRESCRIPTION DRUG LABEL 1 60505-4772 TABLET 10 mg ORAL NDA authorized generic 31 sections
Vilazodone HUMAN PRESCRIPTION DRUG LABEL 1 60505-4773 TABLET 20 mg ORAL NDA authorized generic 31 sections
Vilazodone HUMAN PRESCRIPTION DRUG LABEL 1 60505-4774 TABLET 40 mg ORAL NDA authorized generic 31 sections
VILAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 62332-232 TABLET, FILM COATED 10 mg ORAL ANDA 31 sections
VILAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 62332-233 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
VILAZODONE HYDROCHLORIDE Human Prescription Drug Label 1 62332-234 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections