cariprazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
5037 839712-12-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • cariprazine
  • cariprazine hydrochloride
  • vraylar
  • RGH-188
The efficacy of cariprazine could be mediated through a combination of partial agonist activity at central dopamine D2 and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.
  • Molecular weight: 427.41
  • Formula: C21H32Cl2N4O
  • CLOGP: 4.78
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 1
  • TPSA: 38.82
  • ALOGS: -4.19
  • ROTB: 5
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
3 mg O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2B,AKT2,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MAPK7,MET,NTRK2,PDK2,PDK4,PIK3CB,PIM2,PRKDC,SIK2,TEK,TGFBR1 27
kinase-selectivity-class AXL,GRK2,PDK4,SIK2,STK33 5
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
Sept. 17, 2015 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
Akathisia 588.95 21.73 140 6194 11019 90611094
Tardive dyskinesia 576.18 21.73 137 6197 10793 90611320
Suicidal ideation 164.44 21.73 87 6247 73768 90548345
Extrapyramidal disorder 148.02 21.73 52 6282 16251 90605862
Oculogyric crisis 140.49 21.73 33 6301 2446 90619667
Mania 131.86 21.73 46 6288 14078 90608035
Weight increased 122.50 21.73 148 6186 417779 90204334
Tremor 106.45 21.73 87 6247 153086 90469027
Dyskinesia 104.46 21.73 51 6283 36483 90585630
Hyperprolactinaemia 101.54 21.73 30 6304 5403 90616710
Blood prolactin increased 80.91 21.73 23 6311 3614 90618499
Sedation 80.42 21.73 47 6287 48124 90573989
Bipolar disorder 79.02 21.73 28 6306 8957 90613156
Parkinsonism 70.19 21.73 29 6305 14036 90608077
Restlessness 65.34 21.73 37 6297 35683 90586430
Dystonia 62.01 21.73 28 6306 16791 90605322
Increased appetite 61.23 21.73 25 6309 11740 90610373
Distributive shock 55.74 21.73 17 6317 3407 90618706
Serotonin syndrome 55.51 21.73 34 6300 37853 90584260
Product administration interrupted 53.15 21.73 23 6311 12469 90609644
Intentional overdose 50.29 21.73 46 6288 93788 90528325
Off label use 49.79 21.73 179 6155 1102073 89520040
Drug interaction 49.05 21.73 77 6257 276376 90345737
Anxiety 47.81 21.73 81 6253 309691 90312422
Suicide attempt 46.44 21.73 40 6294 75359 90546754
Dissociation 44.52 21.73 17 6317 6698 90615415
Amniotic fluid volume increased 42.98 21.73 8 6326 188 90621925
Hallucination, auditory 38.86 21.73 20 6314 15955 90606158
Amenorrhoea 38.46 21.73 18 6316 11704 90610409
Vision blurred 37.01 21.73 42 6292 110251 90511862
Pregnancy 36.36 21.73 32 6302 62015 90560098
Lactation disorder 36.28 21.73 8 6326 446 90621667
Muscle twitching 36.16 21.73 22 6312 24180 90597933
Manic symptom 35.59 21.73 6 6328 78 90622035
Somnolence 33.98 21.73 56 6278 209028 90413085
Tongue discomfort 33.66 21.73 11 6323 2754 90619359
Salivary hypersecretion 33.07 21.73 15 6319 9077 90613036
Compulsive shopping 32.08 21.73 8 6326 761 90621352
Drooling 31.91 21.73 12 6322 4534 90617579
Panic attack 29.56 21.73 20 6314 26345 90595768
Product use in unapproved indication 28.99 21.73 69 6265 336167 90285946
Sinus tachycardia 28.14 21.73 20 6314 28493 90593620
Atrioventricular block first degree 27.71 21.73 13 6321 8498 90613615
Psychotic symptom 27.56 21.73 9 6325 2247 90619866
Restless legs syndrome 27.49 21.73 18 6316 22452 90599661
Euphoric mood 26.46 21.73 11 6323 5398 90616715
Accommodation disorder 26.04 21.73 6 6328 408 90621705
Neuroleptic malignant syndrome 25.89 21.73 15 6319 15081 90607032
Tongue thrust 25.71 21.73 3 6331 0 90622113
Paranoia 25.30 21.73 14 6320 12894 90609219
Bruxism 25.22 21.73 10 6324 4353 90617760
Somnambulism 24.97 21.73 11 6323 6217 90615896
Psychiatric decompensation 24.75 21.73 8 6326 1935 90620178
Mechanical urticaria 23.79 21.73 6 6328 598 90621515
Breast discharge 23.73 21.73 7 6327 1252 90620861
Seizure 23.60 21.73 40 6294 152589 90469524
Agitation 23.26 21.73 26 6308 67072 90555041
Treatment noncompliance 23.20 21.73 23 6311 51704 90570409
Facial spasm 22.23 21.73 6 6328 778 90621335
Feeling abnormal 22.21 21.73 41 6293 167194 90454919
Depression 22.02 21.73 58 6276 300543 90321570
Maternal exposure during pregnancy 21.97 21.73 65 6269 359998 90262115
Talipes 21.74 21.73 7 6327 1673 90620440

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
Akathisia 199.08 35.74 62 3776 10389 42607108
Extrapyramidal disorder 164.15 35.74 60 3778 16352 42601145
Tardive dyskinesia 152.74 35.74 46 3792 6878 42610619
Hallucination, auditory 132.67 35.74 50 3788 14814 42602683
Suicidal ideation 99.74 35.74 59 3779 48102 42569395
Delusion 94.36 35.74 39 3799 14695 42602802
Parkinsonism 92.10 35.74 35 3803 10588 42606909
Treatment noncompliance 80.19 35.74 47 3791 37625 42579872
Sedation 78.28 35.74 43 3795 30432 42587065
Neuroleptic malignant syndrome 74.30 35.74 37 3801 21435 42596062
Weight increased 70.54 35.74 66 3772 107917 42509580
Orthostatic hypertension 61.19 35.74 13 3825 469 42617028
Tremor 57.11 35.74 56 3782 96873 42520624
Myocarditis 54.98 35.74 29 3809 18909 42598588
Hallucination, tactile 53.15 35.74 12 3826 576 42616921
Red blood cell sedimentation rate decreased 50.05 35.74 10 3828 265 42617232
Social anxiety disorder 47.44 35.74 11 3827 595 42616902
Neglect of personal appearance 47.09 35.74 10 3828 360 42617137
Persecutory delusion 46.90 35.74 16 3822 3548 42613949
Negative symptoms in schizophrenia 45.94 35.74 8 3830 97 42617400
Blood prolactin increased 45.23 35.74 14 3824 2284 42615213
Psychotic symptom 44.69 35.74 14 3824 2376 42615121
Spasmodic dysphonia 43.68 35.74 10 3828 511 42616986
Anterograde amnesia 43.32 35.74 9 3829 291 42617206
Schizoaffective disorder 43.03 35.74 13 3825 1957 42615540
Orthostatic hypotension 42.13 35.74 29 3809 30541 42586956
Circulatory failure neonatal 41.58 35.74 6 3832 18 42617479
Dystonia 41.17 35.74 21 3817 12769 42604728
Hallucinations, mixed 39.71 35.74 14 3824 3421 42614076
Cataract nuclear 39.45 35.74 10 3828 787 42616710
Psychotic disorder 38.59 35.74 27 3811 29181 42588316
Restlessness 38.55 35.74 27 3811 29222 42588275
Insomnia 38.18 35.74 50 3788 118203 42499294
Drug ineffective 36.93 35.74 132 3706 630065 41987432
Aggression 36.73 35.74 31 3807 44132 42573365
Hypersexuality 36.18 35.74 11 3827 1691 42615806

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
Tardive dyskinesia 386.58 22.45 102 6912 13477 110568808
Akathisia 363.21 22.45 102 6912 17011 110565274
Extrapyramidal disorder 239.70 22.45 84 6930 28783 110553502
Suicidal ideation 205.82 22.45 106 6908 93831 110488454
Sedation 144.98 22.45 76 6938 69607 110512678
Parkinsonism 133.69 22.45 51 6963 22136 110560149
Hallucination, auditory 125.09 22.45 51 6963 26346 110555939
Weight increased 106.79 22.45 132 6882 419512 110162773
Mania 104.79 22.45 42 6972 20754 110561531
Tremor 104.53 22.45 93 6921 202139 110380146
Neuroleptic malignant syndrome 90.90 22.45 44 6970 34015 110548270
Delusion 86.26 22.45 38 6976 23717 110558568
Dissociation 83 22.45 29 6985 9813 110572472
Oculogyric crisis 81.93 22.45 23 6991 3809 110578476
Treatment noncompliance 78.57 22.45 52 6962 72938 110509347
Dystonia 70.86 22.45 34 6980 25771 110556514
Cataract nuclear 67.14 22.45 16 6998 1390 110580895
Blood prolactin increased 64.69 22.45 20 6994 4622 110577663
Drug interaction 62.75 22.45 113 6901 500070 110082215
Myocarditis 57.42 22.45 31 6983 30024 110552261
Dyskinesia 56.19 22.45 37 6977 51409 110530876
Orthostatic hypertension 55.83 22.45 13 7001 1022 110581263
Bipolar disorder 55.29 22.45 21 6993 8986 110573299
Hallucination, tactile 50.81 22.45 12 7002 1003 110581282
Suicide attempt 50.28 22.45 46 6968 103348 110478937
Schizoaffective disorder 50.06 22.45 15 6999 3121 110579164
Neglect of personal appearance 49.46 22.45 10 7004 404 110581881
Distributive shock 48.26 22.45 17 6997 5887 110576398
Persecutory delusion 47.20 22.45 17 6997 6274 110576011
Spasmodic dysphonia 46.18 22.45 10 7004 565 110581720
Social anxiety disorder 46.16 22.45 11 7003 955 110581330
Paranoia 45.33 22.45 24 6990 22350 110559935
Amniotic fluid volume increased 45.13 22.45 8 7006 157 110582128
Mental impairment 45.06 22.45 24 6990 22615 110559670
Psychotic symptom 42.88 22.45 14 7000 3853 110578432
Negative symptoms in schizophrenia 42.83 22.45 8 7006 212 110582073
Aggression 42.54 22.45 33 6981 59177 110523108
Increased appetite 41.92 22.45 20 6994 14957 110567328
Restlessness 41.82 22.45 32 6982 56227 110526058
Obsessive-compulsive symptom 39.62 22.45 8 7006 321 110581964
Intentional overdose 39.01 22.45 45 6969 132456 110449829
Hypersexuality 38.56 22.45 11 7003 1929 110580356
Serotonin syndrome 38.27 22.45 31 6983 59122 110523163
Anxiety 38.23 22.45 74 6940 345004 110237281
Red blood cell sedimentation rate decreased 37.82 22.45 10 7004 1324 110580961
Withdrawal syndrome 37.78 22.45 24 6990 31356 110550929
Delusion of grandeur 36.90 22.45 11 7003 2249 110580036
Psychotic disorder 35.74 22.45 28 6986 50909 110531376
Bruxism 35.62 22.45 13 7001 4981 110577304
Manic symptom 34.47 22.45 7 7007 289 110581996
Off label use 33.07 22.45 184 6830 1500001 109082284
Strabismus 32.17 22.45 11 7003 3488 110578797
Hyperprolactinaemia 32.14 22.45 13 7001 6562 110575723
Compulsive shopping 31.89 22.45 8 7006 860 110581425
Anterograde amnesia 31.71 22.45 8 7006 880 110581405
Pleurothotonus 31.62 22.45 10 7004 2488 110579797
Product administration interrupted 31.36 22.45 15 6999 11277 110571008
Orthostatic hypotension 29.35 22.45 28 6986 66221 110516064
Accommodation disorder 28.96 22.45 7 7007 646 110581639
Alcohol abuse 28.49 22.45 11 7003 4918 110577367
Slow speech 28.45 22.45 10 7004 3438 110578847
Somnolence 28.41 22.45 60 6954 297389 110284896
Salivary hypersecretion 27.89 22.45 16 6998 17405 110564880
Obsessive-compulsive disorder 27.63 22.45 12 7002 7229 110575056
Drug ineffective 26.78 22.45 176 6838 1520364 109061921
Tongue discomfort 26.24 22.45 9 7005 2879 110579406
Agitation 26.14 22.45 34 6980 113017 110469268
Hallucinations, mixed 25.52 22.45 12 7002 8681 110573604
Speech disorder 25.35 22.45 25 6989 61544 110520741
Euphoric mood 25.35 22.45 12 7002 8815 110573470
Pseudohallucination 24.54 22.45 5 7009 210 110582075
Anaemia 24.43 22.45 3 7011 547083 110035202
Abulia 24.11 22.45 7 7007 1306 110580979
Tongue thrust 23.92 22.45 3 7011 3 110582282
Insomnia 23.82 22.45 63 6951 360527 110221758

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05AX15 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Other antipsychotics
FDA EPC N0000175430 Atypical Antipsychotic
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D014149 Tranquilizing Agents
MeSH PA D014150 Antipsychotic Agents
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:51065 dopamine agonist
CHEBI has role CHEBI:65191 second generation antipsychotic
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug

Related Drugs by ATC class:

N05AX Other antipsychotics 11 drugs
aripiprazolebrexpiprazoleiloperidonemosapraminepaliperidonepimavanserinprothipendylrisperidonetrospiumxanomelinezotepine

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

DiseaseRelationSNOMED_IDDOID
Mixed bipolar I disorder indication 16506000 DOID:3312
Schizophrenia indication 58214004 DOID:5419
Bipolar affective disorder, current episode manic indication 191618007




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.04 acidic
pKa2 8.38 Basic
pKa3 1.21 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE47350 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE47350 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49110 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL RE49302 July 16, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER (BIPOLAR DEPRESSION) WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA AND/OR ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH CARIPRAZINE
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL 7737142 Sept. 17, 2029 TREATMENT OF SCHIZOPHRENIA WITH CARIPRAZINE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL Dec. 18, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL Dec. 18, 2028 NEW PATIENT POPULATION
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL Dec. 18, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL Dec. 18, 2028 NEW PATIENT POPULATION
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 NEW PATIENT POPULATION
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 NEW PATIENT POPULATION
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 NEW PATIENT POPULATION
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL Dec. 18, 2028 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 0.5MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL June 18, 2029 PEDIATRIC EXCLUSIVITY
EQ 0.75MG BASE VRAYLAR ABBVIE N204370 Dec. 18, 2025 RX CAPSULE ORAL June 18, 2029 PEDIATRIC EXCLUSIVITY
EQ 1.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL June 18, 2029 PEDIATRIC EXCLUSIVITY
EQ 3MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL June 18, 2029 PEDIATRIC EXCLUSIVITY
EQ 4.5MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL June 18, 2029 PEDIATRIC EXCLUSIVITY
EQ 6MG BASE VRAYLAR ABBVIE N204370 Sept. 17, 2015 RX CAPSULE ORAL June 18, 2029 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
D(2) dopamine receptor GPCR PARTIAL AGONIST Ki 9.31 SCIENTIFIC LITERATURE DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR PARTIAL AGONIST Ki 8.59 SCIENTIFIC LITERATURE DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 7.73 SCIENTIFIC LITERATURE DRUG LABEL
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 4.68 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.51 CHEMBL
5-hydroxytryptamine receptor 6 GPCR Ki 5.89 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 6.62 CHEMBL
Alpha-2B adrenergic receptor GPCR Ki 5.96 CHEMBL
D(1B) dopamine receptor GPCR Ki 5.10 CHEMBL
Muscarinic acetylcholine receptor M4 GPCR Ki 6.11 CHEMBL
Muscarinic acetylcholine receptor M5 GPCR Ki 5.84 CHEMBL
5-hydroxytryptamine receptor 1B GPCR Ki 6.89 CHEMBL
5-hydroxytryptamine receptor 1D GPCR Ki 7.11 CHEMBL
Alpha-2C adrenergic receptor GPCR Ki 6.63 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.71 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 6.65 CHEMBL
Alpha-1B adrenergic receptor GPCR Ki 5.71 CHEMBL
5-hydroxytryptamine receptor 5A GPCR Ki 5.48 CHEMBL
Transmembrane protein 97 Enzyme Ki 6.31 CHEMBL
5-hydroxytryptamine receptor 2B GPCR ANTAGONIST Ki 9.24 SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 6.87 SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 7 GPCR Ki 6.95 SCIENTIFIC LITERATURE
D(3) dopamine receptor GPCR PARTIAL AGONIST Ki 10.07 SCIENTIFIC LITERATURE
Histamine H1 receptor GPCR ANTAGONIST Ki 7.63 SCIENTIFIC LITERATURE
Alpha-1D adrenergic receptor GPCR Ki 6.68 SCIENTIFIC LITERATURE
D(4) dopamine receptor GPCR Ki 6.96 CHEMBL
D(1A) dopamine receptor GPCR Ki 5.68 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 5.76 CHEMBL
D(2) dopamine receptor GPCR IC50 7.80 CHEMBL
D(3) dopamine receptor GPCR IC50 8.80 CHEMBL

External reference:

IDSource
F6RJL8B278 UNII
D09997 KEGG_DRUG
1083076-69-0 SECONDARY_CAS_RN
4035436 VANDF
C2936870 UMLSCUI
CHEBI:90933 CHEBI
7RU PDB_CHEM_ID
CHEMBL2028019 ChEMBL_ID
11154555 PUBCHEM_CID
DB06016 DRUGBANK_ID
CHEMBL2024517 ChEMBL_ID
8920 INN_ID
C533287 MESH_SUPPLEMENTAL_RECORD_UI
7671 IUPHAR_LIGAND_ID
1667655 RXNORM
236113 MMSL
31191 MMSL
d08379 MMSL
016462 NDDF
016463 NDDF
1172432002 SNOMEDCT_US
715295006 SNOMEDCT_US
763607001 SNOMEDCT_US
F6RJL8B278 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Vraylar HUMAN PRESCRIPTION DRUG LABEL 1 61874-115 CAPSULE, GELATIN COATED 1.50 mg ORAL NDA 38 sections
Vraylar HUMAN PRESCRIPTION DRUG LABEL 1 61874-130 CAPSULE, GELATIN COATED 3 mg ORAL NDA 38 sections
Vraylar HUMAN PRESCRIPTION DRUG LABEL 1 61874-145 CAPSULE, GELATIN COATED 4.50 mg ORAL NDA 38 sections
Vraylar HUMAN PRESCRIPTION DRUG LABEL 1 61874-160 CAPSULE, GELATIN COATED 6 mg ORAL NDA 38 sections
Vraylar HUMAN PRESCRIPTION DRUG LABEL 1 61874-250 CAPSULE, GELATIN COATED 0.50 mg ORAL NDA 38 sections
Vraylar HUMAN PRESCRIPTION DRUG LABEL 1 61874-275 CAPSULE, GELATIN COATED 0.75 mg ORAL NDA 38 sections