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

Stem definitionDrug idCAS RN
4168 367514-87-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • SM-13496
  • latuda
  • lurasidone hydrochloride
  • lurasidone
  • lurasidone HCl
The mechanism of action of lurasidone in the treatment of schizophrenia and bipolar depression is unclear. However, its efficacy in schizophrenia and bipolar depression could be mediated through a combination of central dopamine D2 and serotonin Type 2 (5HT2A) receptor antagonism.
  • Molecular weight: 492.68
  • Formula: C28H36N4O2S
  • CLOGP: 6.07
  • LIPINSKI: 1
  • HAC: 6
  • HDO: 0
  • TPSA: 56.75
  • ALOGS: -4.80
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
60 mg O

ADMET properties:

PropertyValueReference
BA (Bioavailability) 14 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 4.953 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 1.122 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 4.477 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 37.411 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 0.290 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 0.800 % High 1
herg hERG pIC50 5.562 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 23.496 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 246.037 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 0.270 % High 1
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2B,CAMK2D,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,MAPK10,MET,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PRKDC 20
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.304 High 1
mh-clint Mouse hepatocyte intrinsic clearance 164.437 High 1
mppb Mouse plasma protein binding (% unbound) 0.360 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.371 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 0.980 % High 1
rh-clint Rat hepatocyte intrinsic clearance 251.768 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 1.560 % High 1
rppb Rat plasma protein binding (% unbound) 0.150 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 0.800 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 25, 2020 PMDA Sumitomo Dainippon Pharma Co., Ltd.
Oct. 28, 2010 FDA SUNOVION PHARMS INC

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
Blood prolactin abnormal 1310.34 19.49 257 15925 3009 90609256
Anosognosia 1278.94 19.49 255 15927 3267 90608998
Sexual dysfunction 1251.56 19.49 264 15918 4540 90607725
Disturbance in social behaviour 1205.70 19.49 250 15932 3938 90608327
Metabolic disorder 1167.38 19.49 270 15912 7200 90605065
Personality change 1014.14 19.49 240 15942 7081 90605184
Dystonia 977.05 19.49 276 15906 16543 90595722
Dyskinesia 947.08 19.49 323 15859 36211 90576054
Suicide attempt 906.94 19.49 380 15802 75019 90537246
Sedation 900.09 19.49 334 15848 47837 90564428
Blood glucose increased 487.18 19.49 267 15915 94979 90517286
Completed suicide 436.17 19.49 289 15893 144769 90467496
Suicidal ideation 341.80 19.49 194 15988 73661 90538604
Akathisia 301.73 19.49 102 16080 11057 90601208
Tardive dyskinesia 291.96 19.49 99 16083 10831 90601434
Mania 263.48 19.49 98 16084 14026 90598239
Hyperprolactinaemia 156.10 19.49 52 16130 5381 90606884
Insurance issue 150.88 19.49 61 16121 10897 90601368
Adverse drug reaction 144.15 19.49 138 16044 116563 90495702
Drug ineffective 137.53 19.49 547 15635 1383751 89228514
Serotonin syndrome 137.08 19.49 85 16097 37802 90574463
Condition aggravated 131.49 19.49 312 15870 595233 90017032
Schizophrenia 120.38 19.49 57 16125 14857 90597408
Oculogyric crisis 118.44 19.49 35 16147 2444 90609821
Personality change due to a general medical condition 111.21 19.49 22 16160 268 90611997
Extrapyramidal disorder 109.63 19.49 55 16127 16248 90596017
Psychotic symptom 104.07 19.49 31 16151 2225 90610040
Delusion 102.91 19.49 50 16132 13790 90598475
Blood prolactin increased 101.26 19.49 34 16148 3603 90608662
Galactorrhoea 100.41 19.49 36 16146 4636 90607629
Hallucination, auditory 90.42 19.49 48 16134 15927 90596338
Bipolar disorder 83.91 19.49 38 16144 8947 90603318
Confabulation 74.22 19.49 16 16166 304 90611961
Depression 72.11 19.49 163 16019 300438 90311827
Myocarditis 71.20 19.49 39 16143 13767 90598498
Diarrhoea 69.44 19.49 41 16141 939149 89673116
Agitation 65.65 19.49 70 16112 67028 90545237
Weight increased 65.46 19.49 193 15989 417734 90194531
Psychotic disorder 65.31 19.49 50 16132 31180 90581085
Joint swelling 62.72 19.49 8 16174 503292 90108973
Drug interaction 61.98 19.49 146 16036 276307 90335958
Restlessness 59.40 19.49 50 16132 35670 90576595
Arthralgia 56.07 19.49 35 16147 778487 89833778
Infusion related reaction 56.07 19.49 5 16177 416775 90195490
Tremor 54.58 19.49 98 16084 153075 90459190
Alopecia 52.61 19.49 12 16170 495059 90117206
Persistent genital arousal disorder 52.19 19.49 14 16168 686 90611579
Systemic lupus erythematosus 49.60 19.49 4 16178 361892 90250373
Somnolence 48.55 19.49 112 16070 208972 90403293
Mental disorder 47.18 19.49 42 16140 32276 90579989
Therapy cessation 46.73 19.49 44 16138 36317 90575948
Rhabdomyolysis 45.82 19.49 51 16131 51205 90561060
Distractibility 45.58 19.49 12 16170 547 90611718
Infection 44.50 19.49 6 16176 362088 90250177
Parkinsonism 42.05 19.49 28 16154 14037 90598228
Rheumatoid arthritis 40.12 19.49 8 16174 362606 90249659
Pain 39.33 19.49 74 16108 996267 89615998
Swelling 39.19 19.49 13 16169 419045 90193220
Negative symptoms in schizophrenia 38.70 19.49 8 16174 123 90612142
Intentional overdose 38.60 19.49 64 16118 93770 90518495
Withdrawal syndrome 38.42 19.49 32 16150 22492 90589773
Anxiety 37.44 19.49 131 16051 309641 90302624
Treatment noncompliance 37.13 19.49 46 16136 51681 90560584
Amenorrhoea 36.66 19.49 24 16158 11698 90600567
Depressed mood 36.60 19.49 45 16137 50177 90562088
Hepatic enzyme increased 35.88 19.49 10 16172 360726 90251539
Off label use 35.34 19.49 325 15857 1101927 89510338
Pneumonia 34.38 19.49 38 16144 638021 89974244
Nystagmus 33.40 19.49 19 16163 7208 90605057
Generalised tonic-clonic seizure 33.40 19.49 36 16146 34867 90577398
Mood altered 32.70 19.49 26 16156 17118 90595147
Hallucination 32.68 19.49 49 16133 65910 90546355
Abdominal discomfort 32.22 19.49 23 16159 477305 90134960
Hyperinsulinaemia 32.08 19.49 7 16175 141 90612124
Salivary hypersecretion 31.86 19.49 20 16162 9072 90603193
Psychomotor retardation 31.73 19.49 16 16166 4773 90607492
Anger 30.97 19.49 23 16159 13697 90598568
Psychiatric decompensation 30.87 19.49 12 16170 1931 90610334
Peripheral swelling 30.47 19.49 18 16164 413088 90199177
Toxicity to various agents 29.95 19.49 116 16066 287730 90324535
Pericarditis 29.79 19.49 6 16176 270145 90342120
Product use issue 29.52 19.49 11 16171 329908 90282357
Hyperthermia 29.52 19.49 20 16162 10315 90601950
Wheezing 29.10 19.49 4 16178 238076 90374189
Peroneal nerve palsy 28.98 19.49 16 16166 5732 90606533
Lower respiratory tract infection 28.85 19.49 5 16177 250654 90361611
General physical health deterioration 28.34 19.49 14 16168 355101 90257164
Catatonia 28.20 19.49 16 16166 6040 90606225
Paranoia 27.72 19.49 21 16161 12887 90599378
Depressive symptom 27.44 19.49 15 16167 5270 90606995
Crying 27.30 19.49 28 16154 25617 90586648
Drug ineffective for unapproved indication 26.79 19.49 45 16137 66599 90545666
Abdominal pain upper 26.72 19.49 13 16169 332661 90279604
Overdose 26.70 19.49 75 16107 157634 90454631
Sinusitis 26.66 19.49 14 16168 343074 90269191
Anaemia 26.54 19.49 15 16167 352787 90259478
Contraindicated product administered 26.49 19.49 12 16170 320127 90292138
Blood insulin increased 25.89 19.49 6 16176 160 90612105
Dyspnoea 24.78 19.49 78 16104 880877 89731388
Metamyelocyte count increased 24.61 19.49 6 16176 200 90612065
Bruxism 24.37 19.49 13 16169 4350 90607915
Manic symptom 24.06 19.49 5 16177 79 90612186
Apnoea 24.02 19.49 17 16165 9397 90602868
Fibromyalgia 23.98 19.49 4 16178 206265 90406000
Blister 23.66 19.49 8 16174 254990 90357275
Activation syndrome 23.55 19.49 6 16176 240 90612025
Nasopharyngitis 23.30 19.49 23 16159 407081 90205184
Compartment syndrome 23.10 19.49 11 16171 2901 90609364
Mental impairment 22.96 19.49 21 16161 16699 90595566
Irritability 22.88 19.49 30 16152 35632 90576633
Sedation complication 22.72 19.49 21 16161 16923 90595342
Drug intolerance 22.64 19.49 28 16154 447563 90164702
Pre-existing condition improved 22.12 19.49 16 16166 9153 90603112
Cough 22.10 19.49 20 16162 368942 90243323
Abdominal pain 21.91 19.49 23 16159 395698 90216567
Mental status changes 21.85 19.49 33 16149 44646 90567619
Flat affect 21.76 19.49 9 16173 1702 90610563
Apathy 21.61 19.49 17 16165 11023 90601242
Type 2 diabetes mellitus 21.41 19.49 5 16177 203239 90409026
Mobility decreased 21.37 19.49 9 16173 250725 90361540
Feeling abnormal 21.29 19.49 72 16110 167163 90445102
Aggression 21.23 19.49 25 16157 26643 90585622
Intentional self-injury 20.91 19.49 26 16156 29308 90582957
Dyspepsia 20.63 19.49 5 16177 198155 90414110
Liver injury 20.53 19.49 3 16179 170564 90441701
Trismus 20.48 19.49 12 16170 4809 90607456
Cognitive disorder 20.47 19.49 41 16141 69366 90542899
Myelocyte count increased 20.43 19.49 6 16176 410 90611855
Gastric bypass 20.17 19.49 9 16173 2045 90610220
Bipolar II disorder 20.09 19.49 6 16176 434 90611831
Therapeutic response unexpected 19.94 19.49 22 16160 21858 90590407
Pyrexia 19.61 19.49 57 16125 660428 89951837

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
Anosognosia 350.91 26.30 71 7595 973 42612696
Blood prolactin abnormal 320.68 26.30 66 7600 989 42612680
Disturbance in social behaviour 280.13 26.30 65 7601 1738 42611931
Akathisia 252.83 26.30 88 7578 10363 42603306
Dystonia 235.47 26.30 88 7578 12702 42600967
Metabolic disorder 230.25 26.30 68 7598 4720 42608949
Sexual dysfunction 227.33 26.30 73 7593 6702 42606967
Sedation 193.54 26.30 99 7567 30376 42583293
Dyskinesia 183.34 26.30 90 7576 25300 42588369
Personality change 177.11 26.30 58 7608 5661 42608008
Mania 135.65 26.30 56 7610 10491 42603178
Suicide attempt 121.51 26.30 85 7581 46015 42567654
Sedation complication 112.59 26.30 35 7631 2884 42610785
Drug ineffective 109.67 26.30 302 7364 629895 41983774
Neuroleptic malignant syndrome 108.66 26.30 60 7606 21412 42592257
Suicidal ideation 104.61 26.30 79 7587 48082 42565587
Hallucination, auditory 93.42 26.30 48 7618 14816 42598853
Tardive dyskinesia 93.22 26.30 38 7628 6886 42606783
Extrapyramidal disorder 86.16 26.30 47 7619 16365 42597304
Blood glucose increased 79.17 26.30 81 7585 73618 42540051
Agitation 78.91 26.30 76 7590 64238 42549431
Weight increased 75.61 26.30 95 7571 107888 42505781
Completed suicide 64.55 26.30 83 7583 96382 42517287
Serotonin syndrome 61.91 26.30 45 7621 25800 42587869
Psychotic disorder 57.01 26.30 45 7621 29163 42584506
Irritability 54.17 26.30 43 7623 28085 42585584
Nail bed bleeding 52.89 26.30 13 7653 445 42613224
Schizophrenia 52.02 26.30 29 7637 10521 42603148
Aggression 48.21 26.30 49 7617 44114 42569555
Delusion 45.50 26.30 30 7636 14704 42598965
Tremor 42.16 26.30 68 7598 96861 42516808
Antipsychotic drug level increased 41.14 26.30 19 7647 4647 42609022
Myocarditis 40.92 26.30 31 7635 18907 42594762
Restlessness 40.50 26.30 37 7629 29212 42584457
Insomnia 37.24 26.30 72 7594 118181 42495488
Hypometabolism 36.16 26.30 8 7658 171 42613498
Lumbosacral radiculoplexus neuropathy 35.35 26.30 7 7659 85 42613584
Blood prolactin increased 32.25 26.30 13 7653 2285 42611384
Psychotic symptom 31.76 26.30 13 7653 2377 42611292
Depression 31.68 26.30 65 7601 111298 42502371
Anxiety 31.17 26.30 67 7599 118493 42495176
Hypomania 31.16 26.30 13 7653 2495 42611174
Eosinophil count decreased 29.78 26.30 14 7652 3562 42610107
Anaemia 29.72 26.30 7 7659 280271 42333398
Parasomnia 28.51 26.30 8 7658 461 42613208
Paranoia 28.19 26.30 22 7644 14004 42599665
Treatment noncompliance 27.67 26.30 34 7632 37638 42576031
Therapy partial responder 27.07 26.30 25 7641 19996 42593673
Grip strength decreased 26.69 26.30 13 7653 3575 42610094
Grandiosity 26.67 26.30 7 7659 313 42613356

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
Anosognosia 1460.63 20.36 291 19106 3783 110566119
Blood prolactin abnormal 1459.95 20.36 288 19109 3547 110566355
Disturbance in social behaviour 1339.94 20.36 281 19116 4777 110565125
Sexual dysfunction 1283.45 20.36 298 19099 8232 110561670
Metabolic disorder 1206.30 20.36 295 19102 10215 110559687
Personality change 1087.72 20.36 274 19123 10728 110559174
Dystonia 1037.00 20.36 317 19080 25488 110544414
Dyskinesia 953.42 20.36 353 19044 51093 110518809
Sedation 921.08 20.36 374 19023 69309 110500593
Suicide attempt 912.67 20.36 417 18980 102977 110466925
Blood glucose increased 495.18 20.36 301 19096 132195 110437707
Akathisia 436.37 20.36 149 19248 16964 110552938
Completed suicide 434.94 20.36 351 19046 242030 110327872
Suicidal ideation 316.63 20.36 200 19197 93737 110476165
Tardive dyskinesia 283.87 20.36 102 19295 13477 110556425
Mania 251.70 20.36 105 19292 20691 110549211
Drug ineffective 233.43 20.36 686 18711 1519854 109050048
Serotonin syndrome 184.45 20.36 120 19277 59033 110510869
Adverse drug reaction 180.68 20.36 149 19248 105410 110464492
Schizophrenia 164.11 20.36 79 19318 21747 110548155
Insurance issue 160.84 20.36 63 19334 10549 110559353
Hyperprolactinaemia 154.93 20.36 54 19343 6521 110563381
Hallucination, auditory 147.05 20.36 78 19319 26319 110543583
Extrapyramidal disorder 143.25 20.36 79 19318 28788 110541114
Condition aggravated 129.81 20.36 350 19047 734486 109835416
Psychotic symptom 123.80 20.36 40 19357 3827 110566075
Agitation 101.96 20.36 112 19285 112939 110456963
Myocarditis 98.65 20.36 63 19334 29992 110539910
Personality change due to a general medical condition 97.90 20.36 20 19377 295 110569607
Sedation complication 97.58 20.36 54 19343 19801 110550101
Delusion 96.35 20.36 57 19340 23698 110546204
Neuroleptic malignant syndrome 96.22 20.36 65 19332 33994 110535908
Weight increased 85.31 20.36 211 19186 419433 110150469
Oculogyric crisis 84.65 20.36 30 19367 3802 110566100
Psychotic disorder 81.08 20.36 69 19328 50868 110519034
Restlessness 69.38 20.36 66 19331 56193 110513709
Diarrhoea 66.97 20.36 61 19336 1139444 109430458
Confabulation 66.74 20.36 16 19381 505 110569397
Bipolar disorder 62.88 20.36 31 19366 8976 110560926
Drug interaction 58.80 20.36 207 19190 499976 110069926
Aggression 55.69 20.36 60 19337 59150 110510752
Blood prolactin increased 54.67 20.36 23 19374 4619 110565283
Anaemia 53.29 20.36 15 19382 547071 110022831
Irritability 53.16 20.36 53 19344 47756 110522146
Persistent genital arousal disorder 52.92 20.36 14 19383 662 110569240
Infusion related reaction 51.69 20.36 4 19393 381158 110188744
Mental disorder 50.68 20.36 47 19350 38744 110531158
Paranoia 49.97 20.36 37 19360 22337 110547565
Intentional overdose 48.56 20.36 85 19312 132416 110437486
Tremor 47.86 20.36 108 19289 202124 110367778
Depression 47.79 20.36 143 19254 317192 110252710
Antipsychotic drug level increased 45.59 20.36 23 19374 6992 110562910
Nail bed bleeding 45.15 20.36 13 19384 843 110569059
Treatment noncompliance 44.01 20.36 59 19338 72931 110496971
Galactorrhoea 43.69 20.36 19 19378 4136 110565766
Eosinophil count decreased 42.87 20.36 21 19376 5997 110563905
Pneumonia 42.48 20.36 55 19342 876659 109693243
Salivary hypersecretion 41.60 20.36 30 19367 17391 110552511
Parkinsonism 41.46 20.36 33 19364 22154 110547748
Toxicity to various agents 41.10 20.36 180 19217 480375 110089527
Withdrawal syndrome 40.95 20.36 38 19359 31342 110538560
General physical health deterioration 38.98 20.36 13 19384 425282 110144620
Arthralgia 37.66 20.36 49 19348 779583 109790319
Alopecia 37.40 20.36 9 19388 364744 110205158
Infection 37.02 20.36 9 19388 362191 110207711
Drug ineffective for unapproved indication 36.42 20.36 65 19332 102773 110467129
Distractibility 35.83 20.36 11 19386 890 110569012
Swelling 35.34 20.36 9 19388 351032 110218870
Joint swelling 34.94 20.36 17 19380 442828 110127074
Negative symptoms in schizophrenia 34.71 20.36 8 19389 212 110569690
Bruxism 34.30 20.36 17 19380 4977 110564925
Generalised tonic-clonic seizure 34.19 20.36 45 19352 54635 110515267
Dyspnoea 33.71 20.36 92 19305 1106780 109463122
Systemic lupus erythematosus 33.56 20.36 3 19394 254335 110315567
Lumbosacral radiculoplexus neuropathy 33.50 20.36 7 19390 116 110569786
Off label use 32.01 20.36 402 18995 1499783 109070119
Anxiety 30.80 20.36 131 19266 344947 110224955
Peroneal nerve palsy 30.61 20.36 18 19379 7396 110562506
Persecutory delusion 30.60 20.36 17 19380 6274 110563628
Hypometabolism 30.43 20.36 7 19390 184 110569718
Wound 30.30 20.36 3 19394 234434 110335468
Abdominal discomfort 29.75 20.36 16 19381 393842 110176060
Abdominal pain 29.39 20.36 28 19369 512961 110056941
Catatonia 28.22 20.36 20 19377 11280 110558622
Abdominal pain upper 28.15 20.36 13 19384 349098 110220804
Product use issue 27.73 20.36 10 19387 311685 110258217
Hyperinsulinaemia 27.60 20.36 7 19390 280 110569622
Psychomotor retardation 27.23 20.36 17 19380 7775 110562127
Therapy partial responder 27.13 20.36 33 19364 37028 110532874
Suspected suicide 27.11 20.36 22 19375 15177 110554725
Nasopharyngitis 27.01 20.36 18 19379 394343 110175559
Lower respiratory tract infection 26.96 20.36 5 19392 243101 110326801
Wheezing 26.75 20.36 6 19391 255224 110314678
Anger 26.72 20.36 24 19373 18983 110550919
Mood swings 26.67 20.36 26 19371 22786 110547116
Mobility decreased 26.08 20.36 5 19392 237417 110332485
Obsessive-compulsive disorder 25.81 20.36 16 19381 7225 110562677
Negative thoughts 25.74 20.36 10 19387 1636 110568266
Nystagmus 25.52 20.36 19 19378 11558 110558344
Intentional self-injury 25.27 20.36 32 19365 37397 110532505
Asthenia 25.12 20.36 52 19345 688947 109880955
Overdose 25.06 20.36 94 19303 233700 110336202
Mental impairment 24.98 20.36 25 19372 22614 110547288
Pyrexia 24.88 20.36 78 19319 898187 109671715
Tic 24.31 20.36 12 19385 3481 110566421
Hepatic enzyme increased 24.28 20.36 13 19384 320879 110249023
Sinusitis 23.99 20.36 11 19386 296677 110273225
Thrombocytopenia 23.78 20.36 16 19381 348869 110221033
Somnolence 23.57 20.36 109 19288 297340 110272562
Hypomania 23.06 20.36 17 19380 10193 110559709
Grandiosity 22.73 20.36 7 19390 572 110569330
Hypertension 22.65 20.36 34 19363 510050 110059852
Oedema peripheral 22.50 20.36 15 19382 328645 110241257
Social avoidant behaviour 22.07 20.36 13 19384 5356 110564546
Osteoarthritis 21.95 20.36 3 19394 182620 110387282
Polydipsia psychogenic 21.69 20.36 6 19391 336 110569566
Flat affect 21.69 20.36 10 19387 2495 110567407
Hallucination 21.59 20.36 52 19345 101380 110468522
Drug hypersensitivity 21.41 20.36 29 19368 454061 110115841
Depressive symptom 21.26 20.36 15 19382 8399 110561503
Cough 21.25 20.36 30 19367 461611 110108291
Compartment syndrome 20.92 20.36 13 19384 5897 110564005
Hyperthermia 20.78 20.36 22 19375 21250 110548652
Parasomnia 20.76 20.36 7 19390 764 110569138
Blood insulin increased 20.68 20.36 6 19391 400 110569502

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N05AE05 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Indole derivatives
FDA EPC N0000175430 Atypical Antipsychotic
MeSH PA D000317 Adrenergic alpha-Antagonists
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014150 Antipsychotic Agents
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018490 Serotonin Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D018663 Adrenergic Agents
MeSH PA D018674 Adrenergic Antagonists
MeSH PA D058669 Adrenergic alpha-2 Receptor Antagonists
MeSH PA D058830 Serotonin 5-HT2 Receptor Antagonists
MeSH PA D065127 Dopamine D2 Receptor Antagonists
CHEBI has role CHEBI:37887 adrenergic antagonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:65191 second generation antipsychotic

Related Drugs by ATC class:

N05AE Indole derivatives 4 drugs

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

DiseaseRelationSNOMED_IDDOID
Schizophrenia indication 58214004 DOID:5419
Bipolar affective disorder, current episode depression indication 191627008 DOID:3312
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Lowered convulsive threshold contraindication 19260006
Orthostatic hypotension contraindication 28651003
Dysphagia contraindication 40739000
Hyperlipidemia contraindication 55822004 DOID:1168
Hepatic failure contraindication 59927004
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Seizure disorder contraindication 128613002
Impaired renal function disorder contraindication 197663003
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Hyperprolactinemia contraindication 237662005 DOID:12700
Transient ischemic attack contraindication 266257000 DOID:224
Esophageal dysmotility contraindication 266434009 DOID:9192
Syncope contraindication 271594007
Neutropenic disorder contraindication 303011007 DOID:1227
Senile dementia with psychosis contraindication 371026009
Cardiovascular event risk contraindication 395112001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.38 Basic
pKa2 0.27 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9555027 May 26, 2026 TREATMENT OF SCHIZOPHRENIA
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
120MG LATUDA SUNOVION PHARMS INC N200603 April 26, 2012 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
20MG LATUDA SUNOVION PHARMS INC N200603 Dec. 7, 2011 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
40MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
60MG LATUDA SUNOVION PHARMS INC N200603 July 12, 2013 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9259423 May 23, 2031 TREATMENT OF SCHIZOPHRENIA OR BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA AND/OR BIPOLAR DISORDER
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF BIPOLAR DEPRESSION WITH IMPROVEMENT IN ATTENTION FUNCTION IN BIPOLAR DISORDER
80MG LATUDA SUNOVION PHARMS INC N200603 Oct. 28, 2010 RX TABLET ORAL 9827242 May 23, 2031 TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN ATTENTION FUNCTION IN SCHIZOPHRENIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 9.00 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 9.33 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 9.31 DRUG LABEL
Alpha-2C adrenergic receptor GPCR Ki 7.97 DRUG LABEL
Alpha-2A adrenergic receptor GPCR Ki 7.39 DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR Ki 8.20 DRUG LABEL
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 8.17 IUPHAR
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 8.69 IUPHAR
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.77 IUPHAR

External reference:

IDSource
D04820 KEGG_DRUG
367514-88-3 SECONDARY_CAS_RN
4030294 VANDF
4030301 VANDF
CHEBI:70735 CHEBI
CHEMBL1237021 ChEMBL_ID
CHEMBL1615372 ChEMBL_ID
7461 IUPHAR_LIGAND_ID
DB08815 DRUGBANK_ID
22IC88528T UNII
1040027 RXNORM
177747 MMSL
27589 MMSL
365355 MMSL
d07705 MMSL
013606 NDDF
013607 NDDF
703115008 SNOMEDCT_US
703116009 SNOMEDCT_US
715585000 SNOMEDCT_US
C2003424 UMLSCUI
D000069056 MESH_DESCRIPTOR_UI
8247 INN_ID
213046 PUBCHEM_CID
22IC88528T INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7355 TABLET, FILM COATED 20 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7356 TABLET, FILM COATED 40 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7357 TABLET, FILM COATED 60 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7358 TABLET, FILM COATED 80 mg ORAL ANDA 29 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0904-7359 TABLET, FILM COATED 120 mg ORAL ANDA 29 sections
lurasidone hydrochloride Human Prescription Drug Label 1 0904-7421 TABLET, FILM COATED 20 mg ORAL ANDA 28 sections
lurasidone hydrochloride Human Prescription Drug Label 1 0904-7422 TABLET, FILM COATED 40 mg ORAL ANDA 28 sections
lurasidone hydrochloride Human Prescription Drug Label 1 0904-7423 TABLET, FILM COATED 60 mg ORAL ANDA 28 sections
lurasidone hydrochloride Human Prescription Drug Label 1 0904-7424 TABLET, FILM COATED 80 mg ORAL ANDA 28 sections
lurasidone hydrochloride Human Prescription Drug Label 1 0904-7425 TABLET, FILM COATED 120 mg ORAL ANDA 28 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-464 TABLET, FILM COATED 20 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-465 TABLET, FILM COATED 40 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-466 TABLET, FILM COATED 80 mg ORAL ANDA 24 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-467 TABLET, FILM COATED 120 mg ORAL ANDA 24 sections
Lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-509 TABLET, FILM COATED 60 mg ORAL ANDA 21 sections
Lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-509 TABLET, FILM COATED 60 mg ORAL ANDA 21 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 13668-737 TABLET, FILM COATED 60 mg ORAL ANDA 24 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-346 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-346 TABLET, FILM COATED 20 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-347 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-347 TABLET, FILM COATED 40 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-348 TABLET, FILM COATED 60 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-348 TABLET, FILM COATED 60 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-349 TABLET, FILM COATED 80 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-349 TABLET, FILM COATED 80 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-350 TABLET, FILM COATED 120 mg ORAL ANDA 31 sections
lurasidone hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 16729-350 TABLET, FILM COATED 120 mg ORAL ANDA 31 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-887 TABLET, FILM COATED 20 mg ORAL ANDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-888 TABLET, FILM COATED 40 mg ORAL ANDA 20 sections
Lurasidone Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 23155-889 TABLET, FILM COATED 60 mg ORAL ANDA 20 sections