lurasidone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4168 | 367514-87-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 60 | mg | O |
ADMET properties:
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 28, 2010 | FDA | SUNOVION PHARMS INC | |
| March 25, 2020 | PMDA | Sumitomo Dainippon Pharma Co., Ltd. |
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 |
|---|---|---|---|---|---|---|
| Blood prolactin abnormal | 861.02 | 22.35 | 173 | 10149 | 2002 | 50592800 |
| Anosognosia | 838.56 | 22.35 | 170 | 10152 | 2064 | 50592738 |
| Sexual dysfunction | 828.66 | 22.35 | 180 | 10142 | 3112 | 50591690 |
| Disturbance in social behaviour | 772.02 | 22.35 | 166 | 10156 | 2728 | 50592074 |
| Metabolic disorder | 733.56 | 22.35 | 178 | 10144 | 5108 | 50589694 |
| Dystonia | 646.56 | 22.35 | 191 | 10131 | 11735 | 50583067 |
| Personality change | 641.76 | 22.35 | 162 | 10160 | 5483 | 50589319 |
| Dyskinesia | 584.94 | 22.35 | 218 | 10104 | 27643 | 50567159 |
| Sedation | 568.55 | 22.35 | 219 | 10103 | 30391 | 50564411 |
| Suicide attempt | 467.03 | 22.35 | 222 | 10100 | 51510 | 50543292 |
| Blood glucose increased | 288.67 | 22.35 | 180 | 10142 | 71144 | 50523658 |
| Completed suicide | 248.00 | 22.35 | 209 | 10113 | 131680 | 50463122 |
| Tardive dyskinesia | 220.92 | 22.35 | 75 | 10247 | 7204 | 50587598 |
| Mania | 166.93 | 22.35 | 68 | 10254 | 10848 | 50583954 |
| Insurance issue | 160.84 | 22.35 | 46 | 10276 | 2502 | 50592300 |
| Akathisia | 160.02 | 22.35 | 61 | 10261 | 8168 | 50586634 |
| Schizophrenia | 155.31 | 22.35 | 58 | 10264 | 7339 | 50587463 |
| Suicidal ideation | 125.39 | 22.35 | 98 | 10224 | 55287 | 50539515 |
| Blood prolactin increased | 90.35 | 22.35 | 31 | 10291 | 3068 | 50591734 |
| Delusion | 79.05 | 22.35 | 40 | 10282 | 10529 | 50584273 |
| Condition aggravated | 72.92 | 22.35 | 176 | 10146 | 296882 | 50297920 |
| Hyperprolactinaemia | 72.87 | 22.35 | 27 | 10295 | 3338 | 50591464 |
| Confabulation | 67.80 | 22.35 | 15 | 10307 | 281 | 50594521 |
| Adverse drug reaction | 67.49 | 22.35 | 69 | 10253 | 55153 | 50539649 |
| Galactorrhoea | 66.66 | 22.35 | 26 | 10296 | 3697 | 50591105 |
| Persistent genital arousal disorder | 64.56 | 22.35 | 14 | 10308 | 238 | 50594564 |
| Hallucination, auditory | 58.78 | 22.35 | 33 | 10289 | 10695 | 50584107 |
| Depression | 57.63 | 22.35 | 113 | 10209 | 165310 | 50429492 |
| Psychotic disorder | 54.57 | 22.35 | 41 | 10281 | 21771 | 50573031 |
| Serotonin syndrome | 54.29 | 22.35 | 43 | 10279 | 24670 | 50570132 |
| Weight increased | 52.00 | 22.35 | 122 | 10200 | 201769 | 50393033 |
| Diarrhoea | 48.83 | 22.35 | 30 | 10292 | 588446 | 50006356 |
| Distractibility | 47.77 | 22.35 | 12 | 10310 | 395 | 50594407 |
| Restlessness | 47.31 | 22.35 | 40 | 10282 | 25133 | 50569669 |
| Drug ineffective | 41.15 | 22.35 | 296 | 10026 | 819037 | 49775765 |
| Arthralgia | 39.75 | 22.35 | 20 | 10302 | 438682 | 50156120 |
| Negative symptoms in schizophrenia | 38.97 | 22.35 | 8 | 10314 | 103 | 50594699 |
| Off label use | 38.87 | 22.35 | 195 | 10127 | 474231 | 50120571 |
| Psychotic symptom | 38.77 | 22.35 | 13 | 10309 | 1199 | 50593603 |
| Therapy cessation | 38.28 | 22.35 | 36 | 10286 | 25975 | 50568827 |
| Extrapyramidal disorder | 36.00 | 22.35 | 25 | 10297 | 11745 | 50583057 |
| Agitation | 35.66 | 22.35 | 49 | 10273 | 53335 | 50541467 |
| Psychomotor retardation | 34.84 | 22.35 | 16 | 10306 | 3402 | 50591400 |
| Personality change due to a general medical condition | 33.82 | 22.35 | 7 | 10315 | 94 | 50594708 |
| Oculogyric crisis | 32.85 | 22.35 | 12 | 10310 | 1425 | 50593377 |
| Tremor | 32.36 | 22.35 | 72 | 10250 | 114831 | 50479971 |
| Anxiety | 32.02 | 22.35 | 94 | 10228 | 177512 | 50417290 |
| Joint swelling | 31.40 | 22.35 | 6 | 10316 | 245280 | 50349522 |
| Depressed mood | 30.25 | 22.35 | 36 | 10286 | 33987 | 50560815 |
| Hyperthermia | 29.96 | 22.35 | 19 | 10303 | 7677 | 50587125 |
| Bipolar disorder | 29.64 | 22.35 | 18 | 10304 | 6739 | 50588063 |
| Somnolence | 27.90 | 22.35 | 82 | 10240 | 154903 | 50439899 |
| Anger | 27.67 | 22.35 | 21 | 10301 | 11312 | 50583490 |
| Parkinsonism | 27.55 | 22.35 | 19 | 10303 | 8828 | 50585974 |
| Catatonia | 27.52 | 22.35 | 14 | 10308 | 3722 | 50591080 |
| Drug interaction | 26.35 | 22.35 | 95 | 10227 | 199526 | 50395276 |
| Blood insulin increased | 26.16 | 22.35 | 6 | 10316 | 133 | 50594669 |
| Amenorrhoea | 25.90 | 22.35 | 18 | 10304 | 8466 | 50586336 |
| Rheumatoid arthritis | 25.82 | 22.35 | 5 | 10317 | 202545 | 50392257 |
| Alopecia | 25.63 | 22.35 | 9 | 10313 | 245038 | 50349764 |
| Hallucination | 25.57 | 22.35 | 39 | 10283 | 46618 | 50548184 |
| Anaemia | 25.19 | 22.35 | 10 | 10312 | 252446 | 50342356 |
| Nystagmus | 24.87 | 22.35 | 15 | 10307 | 5546 | 50589256 |
| Mental disorder | 24.20 | 22.35 | 26 | 10296 | 21965 | 50572837 |
| Apnoea | 24.17 | 22.35 | 16 | 10306 | 6950 | 50587852 |
| Metamyelocyte count increased | 23.13 | 22.35 | 6 | 10316 | 225 | 50594577 |
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 |
|---|---|---|---|---|---|---|
| Anosognosia | 323.10 | 29.95 | 62 | 4476 | 756 | 29569233 |
| Blood prolactin abnormal | 295.47 | 29.95 | 58 | 4480 | 802 | 29569187 |
| Disturbance in social behaviour | 256.01 | 29.95 | 58 | 4480 | 1644 | 29568345 |
| Metabolic disorder | 216.00 | 29.95 | 59 | 4479 | 3636 | 29566353 |
| Sexual dysfunction | 206.53 | 29.95 | 63 | 4475 | 5751 | 29564238 |
| Dystonia | 205.09 | 29.95 | 71 | 4467 | 9678 | 29560311 |
| Dyskinesia | 168.14 | 29.95 | 75 | 4463 | 19986 | 29550003 |
| Sedation | 152.03 | 29.95 | 67 | 4471 | 17338 | 29552651 |
| Personality change | 150.89 | 29.95 | 47 | 4491 | 4591 | 29565398 |
| Akathisia | 107.40 | 29.95 | 40 | 4498 | 6702 | 29563287 |
| Suicide attempt | 96.85 | 29.95 | 62 | 4476 | 34048 | 29535941 |
| Mania | 90.89 | 29.95 | 38 | 4500 | 8625 | 29561364 |
| Tardive dyskinesia | 79.38 | 29.95 | 30 | 4508 | 5228 | 29564761 |
| Blood glucose increased | 76.55 | 29.95 | 67 | 4471 | 58917 | 29511072 |
| Suicidal ideation | 67.51 | 29.95 | 50 | 4488 | 34666 | 29535323 |
| Hallucination, auditory | 62 | 29.95 | 30 | 4508 | 9563 | 29560426 |
| Completed suicide | 60.92 | 29.95 | 72 | 4466 | 90174 | 29479815 |
| Drug ineffective | 58.32 | 29.95 | 153 | 4385 | 363017 | 29206972 |
| Psychotic disorder | 57.72 | 29.95 | 37 | 4501 | 20317 | 29549672 |
| Neuroleptic malignant syndrome | 55.02 | 29.95 | 33 | 4505 | 16115 | 29553874 |
| Extrapyramidal disorder | 52.82 | 29.95 | 28 | 4510 | 10803 | 29559186 |
| Off label use | 52.62 | 29.95 | 131 | 4407 | 300669 | 29269320 |
| Weight increased | 41.80 | 29.95 | 55 | 4483 | 76612 | 29493377 |
| Aggression | 41.34 | 29.95 | 38 | 4500 | 35503 | 29534486 |
| Insurance issue | 36.78 | 29.95 | 11 | 4527 | 934 | 29569055 |
| Delusion | 35.83 | 29.95 | 22 | 4516 | 11194 | 29558795 |
| Agitation | 34.65 | 29.95 | 41 | 4497 | 51263 | 29518726 |
| Restlessness | 32.42 | 29.95 | 27 | 4511 | 22118 | 29547871 |
| Tremor | 31.48 | 29.95 | 47 | 4491 | 73491 | 29496498 |
| Paranoia | 30.59 | 29.95 | 19 | 4519 | 9858 | 29560131 |
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 |
|---|---|---|---|---|---|---|
| Anosognosia | 1075.60 | 22.00 | 213 | 11472 | 2592 | 64484455 |
| Blood prolactin abnormal | 1075.12 | 22.00 | 212 | 11473 | 2520 | 64484527 |
| Disturbance in social behaviour | 960.61 | 22.00 | 205 | 11480 | 3682 | 64483365 |
| Sexual dysfunction | 940.11 | 22.00 | 221 | 11464 | 6250 | 64480797 |
| Metabolic disorder | 861.46 | 22.00 | 213 | 11472 | 7484 | 64479563 |
| Personality change | 774.39 | 22.00 | 200 | 11485 | 8393 | 64478654 |
| Dystonia | 743.73 | 22.00 | 230 | 11455 | 18635 | 64468412 |
| Dyskinesia | 659.51 | 22.00 | 253 | 11432 | 39135 | 64447912 |
| Sedation | 636.30 | 22.00 | 250 | 11435 | 41212 | 64445835 |
| Suicide attempt | 534.10 | 22.00 | 259 | 11426 | 70748 | 64416299 |
| Blood glucose increased | 348.05 | 22.00 | 218 | 11467 | 97855 | 64389192 |
| Completed suicide | 274.59 | 22.00 | 265 | 11420 | 224149 | 64262898 |
| Tardive dyskinesia | 201.19 | 22.00 | 72 | 11613 | 9106 | 64477941 |
| Insurance issue | 179.69 | 22.00 | 50 | 11635 | 2776 | 64484271 |
| Akathisia | 171.23 | 22.00 | 68 | 11617 | 11442 | 64475605 |
| Schizophrenia | 152.37 | 22.00 | 62 | 11623 | 11106 | 64475941 |
| Mania | 145.35 | 22.00 | 67 | 11618 | 16219 | 64470828 |
| Adverse drug reaction | 110.33 | 22.00 | 80 | 11605 | 45384 | 64441663 |
| Suicidal ideation | 109.35 | 22.00 | 93 | 11592 | 66449 | 64420598 |
| Drug ineffective | 107.52 | 22.00 | 364 | 11321 | 839883 | 63647164 |
| Hallucination, auditory | 89.92 | 22.00 | 49 | 11636 | 16890 | 64470157 |
| Condition aggravated | 87.76 | 22.00 | 202 | 11483 | 372224 | 64114823 |
| Hyperprolactinaemia | 74.64 | 22.00 | 28 | 11657 | 4037 | 64483010 |
| Psychotic disorder | 73.04 | 22.00 | 56 | 11629 | 34522 | 64452525 |
| Persistent genital arousal disorder | 66.61 | 22.00 | 14 | 11671 | 231 | 64486816 |
| Confabulation | 63.02 | 22.00 | 15 | 11670 | 444 | 64486603 |
| Delusion | 61.07 | 22.00 | 39 | 11646 | 17975 | 64469072 |
| Weight increased | 53.75 | 22.00 | 119 | 11566 | 213229 | 64273818 |
| Extrapyramidal disorder | 53.40 | 22.00 | 37 | 11648 | 19515 | 64467532 |
| Restlessness | 52.20 | 22.00 | 49 | 11636 | 39736 | 64447311 |
| Serotonin syndrome | 50.81 | 22.00 | 48 | 11637 | 39234 | 64447813 |
| Neuroleptic malignant syndrome | 47.41 | 22.00 | 38 | 11647 | 24958 | 64462089 |
| Agitation | 46.48 | 22.00 | 68 | 11617 | 88299 | 64398748 |
| Off label use | 45.36 | 22.00 | 230 | 11455 | 632576 | 63854471 |
| Diarrhoea | 45.06 | 22.00 | 39 | 11646 | 722665 | 63764382 |
| Psychotic symptom | 43.94 | 22.00 | 16 | 11669 | 2122 | 64484925 |
| Aggression | 42.51 | 22.00 | 47 | 11638 | 46185 | 64440862 |
| Blood prolactin increased | 39.43 | 22.00 | 17 | 11668 | 3511 | 64483536 |
| Negative symptoms in schizophrenia | 39.29 | 22.00 | 8 | 11677 | 112 | 64486935 |
| Distractibility | 39.10 | 22.00 | 11 | 11674 | 635 | 64486412 |
| Anaemia | 35.82 | 22.00 | 12 | 11673 | 378668 | 64108379 |
| Pneumonia | 33.86 | 22.00 | 31 | 11654 | 559545 | 63927502 |
| Personality change due to a general medical condition | 31.71 | 22.00 | 7 | 11678 | 147 | 64486900 |
| Tremor | 31.07 | 22.00 | 77 | 11608 | 148153 | 64338894 |
| Depression | 30.13 | 22.00 | 87 | 11598 | 183204 | 64303843 |
| Parkinsonism | 29.73 | 22.00 | 23 | 11662 | 14350 | 64472697 |
| Paranoia | 29.19 | 22.00 | 24 | 11661 | 16328 | 64470719 |
| Negative thoughts | 27.59 | 22.00 | 10 | 11675 | 1308 | 64485739 |
| Arthralgia | 27.33 | 22.00 | 24 | 11661 | 442236 | 64044811 |
| General physical health deterioration | 26.55 | 22.00 | 3 | 11682 | 204422 | 64282625 |
| Joint swelling | 25.96 | 22.00 | 4 | 11681 | 215378 | 64271669 |
| Galactorrhoea | 24.88 | 22.00 | 12 | 11673 | 3207 | 64483840 |
| Catatonia | 24.59 | 22.00 | 16 | 11669 | 7604 | 64479443 |
| Sedation complication | 24.59 | 22.00 | 18 | 11667 | 10336 | 64476711 |
| Oculogyric crisis | 24.39 | 22.00 | 11 | 11674 | 2527 | 64484520 |
| Hyperthermia | 24.02 | 22.00 | 21 | 11664 | 15529 | 64471518 |
| Parasomnia | 23.59 | 22.00 | 7 | 11678 | 488 | 64486559 |
| Infection | 23.30 | 22.00 | 3 | 11682 | 184877 | 64302170 |
| Prescribed underdose | 23.26 | 22.00 | 22 | 11663 | 17993 | 64469054 |
| Change in seizure presentation | 22.14 | 22.00 | 6 | 11679 | 301 | 64486746 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05AE05 | NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Indole derivatives |
| FDA EPC | N0000175430 | Atypical Antipsychotic |
| MeSH PA | D018663 | Adrenergic Agents |
| MeSH PA | D058669 | Adrenergic alpha-2 Receptor Antagonists |
| MeSH PA | D000317 | Adrenergic alpha-Antagonists |
| MeSH PA | D018674 | Adrenergic Antagonists |
| MeSH PA | D014150 | Antipsychotic Agents |
| MeSH PA | D002491 | Central Nervous System Agents |
| MeSH PA | D002492 | Central Nervous System Depressants |
| MeSH PA | D015259 | Dopamine Agents |
| MeSH PA | D018492 | Dopamine Antagonists |
| MeSH PA | D065127 | Dopamine D2 Receptor Antagonists |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D058830 | Serotonin 5-HT2 Receptor Antagonists |
| MeSH PA | D018490 | Serotonin Agents |
| MeSH PA | D012702 | Serotonin Antagonists |
| MeSH PA | D014149 | Tranquilizing Agents |
| CHEBI has role | CHEBI:37887 | adrenergic blockers |
| CHEBI has role | CHEBI:48279 | serotonin antagonists |
| CHEBI has role | CHEBI:48561 | dopaminergic antagonists |
| CHEBI has role | CHEBI:65191 | atypical antipsychotic agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| 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 level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.38 | Basic |
| pKa2 | 0.27 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 120MG | LATUDA | SUNOVION PHARMS INC | N200603 | April 26, 2012 | RX | TABLET | ORAL | 9174975 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA |
| 120MG | LATUDA | SUNOVION PHARMS INC | N200603 | April 26, 2012 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER |
| 120MG | LATUDA | SUNOVION PHARMS INC | N200603 | April 26, 2012 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA |
| 20MG | LATUDA | SUNOVION PHARMS INC | N200603 | Dec. 7, 2011 | RX | TABLET | ORAL | 9174975 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA |
| 20MG | LATUDA | SUNOVION PHARMS INC | N200603 | Dec. 7, 2011 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER |
| 20MG | LATUDA | SUNOVION PHARMS INC | N200603 | Dec. 7, 2011 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA |
| 40MG | LATUDA | SUNOVION PHARMS INC | N200603 | Oct. 28, 2010 | RX | TABLET | ORAL | 9174975 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA |
| 40MG | LATUDA | SUNOVION PHARMS INC | N200603 | Oct. 28, 2010 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER |
| 40MG | LATUDA | SUNOVION PHARMS INC | N200603 | Oct. 28, 2010 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA |
| 60MG | LATUDA | SUNOVION PHARMS INC | N200603 | July 12, 2013 | RX | TABLET | ORAL | 9174975 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA |
| 60MG | LATUDA | SUNOVION PHARMS INC | N200603 | July 12, 2013 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER |
| 60MG | LATUDA | SUNOVION PHARMS INC | N200603 | July 12, 2013 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA |
| 80MG | LATUDA | SUNOVION PHARMS INC | N200603 | Oct. 28, 2010 | RX | TABLET | ORAL | 9174975 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN NEGATIVE SYMPTOMS AND/OR COGNITIVE DYSFUNCTION OF SCHIZOPHRENIA |
| 80MG | LATUDA | SUNOVION PHARMS INC | N200603 | Oct. 28, 2010 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER |
| 80MG | LATUDA | SUNOVION PHARMS INC | N200603 | Oct. 28, 2010 | RX | TABLET | ORAL | 9815827 | Feb. 20, 2024 | TREATMENT OF SCHIZOPHRENIA |
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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:
| ID | Source |
|---|---|
| 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 |
| 8247 | INN_ID |
| DB08815 | DRUGBANK_ID |
| 22IC88528T | UNII |
| 213046 | PUBCHEM_CID |
| 1040027 | RXNORM |
| 177747 | MMSL |
| 27589 | MMSL |
| d07705 | MMSL |
| 013606 | NDDF |
| 013607 | NDDF |
| 703115008 | SNOMEDCT_US |
| 703116009 | SNOMEDCT_US |
| 715585000 | SNOMEDCT_US |
| D000069056 | MESH_DESCRIPTOR_UI |
| C2003424 | UMLSCUI |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| 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 | 46708-494 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 46708-495 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 46708-496 | TABLET, FILM COATED | 60 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 46708-497 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 46708-498 | TABLET, FILM COATED | 120 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 62332-494 | TABLET, FILM COATED | 20 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 62332-495 | TABLET, FILM COATED | 40 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 62332-496 | TABLET, FILM COATED | 60 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 62332-497 | TABLET, FILM COATED | 80 mg | ORAL | ANDA | 31 sections |
| Lurasidone Hydrochloride | Human Prescription Drug Label | 1 | 62332-498 | TABLET, FILM COATED | 120 mg | ORAL | ANDA | 31 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-302 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 32 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-304 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 32 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-306 | TABLET, FILM COATED | 60 mg | ORAL | NDA | 32 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-308 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 32 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 63402-312 | TABLET, FILM COATED | 120 mg | ORAL | NDA | 32 sections |
| Lurasidone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-082 | TABLET, COATED | 60 mg | ORAL | ANDA | 29 sections |
| Lurasidone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-879 | TABLET, COATED | 20 mg | ORAL | ANDA | 29 sections |
| Lurasidone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-880 | TABLET, COATED | 40 mg | ORAL | ANDA | 29 sections |
| Lurasidone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-881 | TABLET, COATED | 80 mg | ORAL | ANDA | 29 sections |
| Lurasidone Hydrochloride | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65162-882 | TABLET, COATED | 120 mg | ORAL | ANDA | 29 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-1812 | TABLET, FILM COATED | 60 mg | ORAL | NDA | 31 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-1936 | TABLET, FILM COATED | 120 mg | ORAL | NDA | 31 sections |
| Latuda | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70518-3010 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 31 sections |