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aripiprazole lauroxil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| psychotropics, phenylpiperazine derivatives | 5052 | 1259305-29-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
prodrug of aripiprazole, following intramuscular injection is converted by enzyme-mediated hydrolysis to N-hydroxymethyl aripiprazole which is then hydrolyzed to aripiprazole
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK1,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PAK4,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ZAP70 | 60 | |||
| kinase-selectivity-class | AXL,CDK4,EIF2AK3,EPHB4,GRK2,MAP2K6,PDK4,STK33,TEK | 9 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 5, 2015 | FDA | ALKERMES |
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 |
|---|---|---|---|---|---|---|
| Needle issue | 1025.83 | 45.64 | 201 | 2828 | 13733 | 90611685 |
| Off label use | 489.45 | 45.64 | 349 | 2680 | 1101903 | 89523515 |
| Syringe issue | 294.88 | 45.64 | 58 | 2971 | 3944 | 90621474 |
| Injection site pain | 292.02 | 45.64 | 133 | 2896 | 173566 | 90451852 |
| Wrong technique in device usage process | 290.29 | 45.64 | 61 | 2968 | 5774 | 90619644 |
| Product administered at inappropriate site | 221.46 | 45.64 | 46 | 2983 | 4105 | 90621313 |
| Injection site mass | 214.06 | 45.64 | 62 | 2967 | 22028 | 90603390 |
| Incorrect dose administered | 166.19 | 45.64 | 71 | 2958 | 78859 | 90546559 |
| Hallucination, auditory | 155.40 | 45.64 | 45 | 2984 | 15930 | 90609488 |
| Product physical consistency issue | 128.49 | 45.64 | 23 | 3006 | 931 | 90624487 |
| Injection site induration | 104.04 | 45.64 | 30 | 2999 | 10438 | 90614980 |
| Therapeutic response shortened | 103.64 | 45.64 | 36 | 2993 | 22843 | 90602575 |
| Wrong technique in product usage process | 95.69 | 45.64 | 47 | 2982 | 71524 | 90553894 |
| Product administration error | 83.93 | 45.64 | 32 | 2997 | 26391 | 90599027 |
| Product leakage | 65.82 | 45.64 | 14 | 3015 | 1394 | 90624024 |
| Paranoia | 65.01 | 45.64 | 22 | 3007 | 12886 | 90612532 |
| Inappropriate schedule of product administration | 56.86 | 45.64 | 44 | 2985 | 149889 | 90475529 |
| Weight increased | 54.08 | 45.64 | 68 | 2961 | 417859 | 90207559 |
| Occupational exposure to product | 52.57 | 45.64 | 13 | 3016 | 2518 | 90622900 |
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 |
|---|---|---|---|---|---|---|
| Needle issue | 801.07 | 57.28 | 174 | 3055 | 8553 | 42609553 |
| Product administered at inappropriate site | 501.17 | 57.28 | 99 | 3130 | 2999 | 42615107 |
| Injection site pain | 310.81 | 57.28 | 128 | 3101 | 57670 | 42560436 |
| Off label use | 285.36 | 57.28 | 289 | 2940 | 638046 | 41980060 |
| Wrong technique in device usage process | 224.50 | 57.28 | 50 | 3179 | 2707 | 42615399 |
| Hallucination, auditory | 196.31 | 57.28 | 64 | 3165 | 14800 | 42603306 |
| Therapeutic response shortened | 169.43 | 57.28 | 56 | 3173 | 13498 | 42604608 |
| Syringe issue | 163.96 | 57.28 | 49 | 3180 | 8507 | 42609599 |
| Incorrect dose administered | 155.32 | 57.28 | 77 | 3152 | 52897 | 42565209 |
| Product physical consistency issue | 103.52 | 57.28 | 22 | 3207 | 951 | 42617155 |
| Injection site mass | 78.15 | 57.28 | 28 | 3201 | 8547 | 42609559 |
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 |
|---|---|---|---|---|---|---|
| Needle issue | 1469.06 | 47.11 | 300 | 4975 | 17540 | 110566484 |
| Off label use | 586.27 | 47.11 | 512 | 4763 | 1499673 | 109084351 |
| Injection site pain | 525.46 | 47.11 | 225 | 5050 | 177697 | 110406327 |
| Product administered at inappropriate site | 515.49 | 47.11 | 103 | 5172 | 5290 | 110578734 |
| Wrong technique in device usage process | 404.85 | 47.11 | 88 | 5187 | 6813 | 110577211 |
| Syringe issue | 360.82 | 47.11 | 85 | 5190 | 9440 | 110574584 |
| Hallucination, auditory | 300.55 | 47.11 | 91 | 5184 | 26306 | 110557718 |
| Injection site mass | 255.26 | 47.11 | 79 | 5196 | 24534 | 110559490 |
| Incorrect dose administered | 252.99 | 47.11 | 115 | 5160 | 103526 | 110480498 |
| Therapeutic response shortened | 209.07 | 47.11 | 71 | 5204 | 29512 | 110554512 |
| Product physical consistency issue | 202.21 | 47.11 | 38 | 5237 | 1402 | 110582622 |
| Injection site induration | 119.87 | 47.11 | 37 | 5238 | 11346 | 110572678 |
| Product dose omission issue | 105.34 | 47.11 | 101 | 5174 | 321681 | 110262343 |
| Weight increased | 103.43 | 47.11 | 113 | 5162 | 419531 | 110164493 |
| Wrong technique in product usage process | 101.83 | 47.11 | 59 | 5216 | 87289 | 110496735 |
| Product leakage | 91.26 | 47.11 | 20 | 5255 | 1598 | 110582426 |
| Inappropriate schedule of product administration | 90.48 | 47.11 | 76 | 5199 | 203561 | 110380463 |
| Product administration error | 83.40 | 47.11 | 39 | 5236 | 37178 | 110546846 |
| Paranoia | 81.40 | 47.11 | 33 | 5242 | 22341 | 110561683 |
| Anxiety | 71.46 | 47.11 | 85 | 5190 | 344993 | 110239031 |
| Restlessness | 68.19 | 47.11 | 39 | 5236 | 56220 | 110527804 |
| Treatment noncompliance | 66.21 | 47.11 | 42 | 5233 | 72948 | 110511076 |
| Soliloquy | 59.62 | 47.11 | 13 | 5262 | 1014 | 110583010 |
| Anger | 58.89 | 47.11 | 25 | 5250 | 18982 | 110565042 |
| Mania | 53.51 | 47.11 | 24 | 5251 | 20772 | 110563252 |
| Abnormal behaviour | 52.55 | 47.11 | 29 | 5246 | 39010 | 110545014 |
| Feeling abnormal | 52.07 | 47.11 | 53 | 5222 | 180658 | 110403366 |
| Product administered by wrong person | 50.22 | 47.11 | 8 | 5267 | 108 | 110583916 |
| Restless legs syndrome | 49.63 | 47.11 | 24 | 5251 | 24602 | 110559422 |
| Underdose | 48.90 | 47.11 | 33 | 5242 | 63521 | 110520503 |
| Thinking abnormal | 47.18 | 47.11 | 20 | 5255 | 15120 | 110568904 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| 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:35941 | serotonergic agonist |
| CHEBI has role | CHEBI:37955 | H<small><sub>1</sub></small>-receptor antagonist |
| CHEBI has role | CHEBI:50266 | prodrug |
| CHEBI has role | CHEBI:65191 | second generation antipsychotic |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Schizophrenia | indication | 58214004 | DOID:5419 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 7.84 | Basic |
| pKa2 | 0.67 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10112903 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 8796276 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10112903 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 8796276 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10112903 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 8796276 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10112903 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 8796276 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 675MG/2.4ML (281.25MG/ML) | ARISTADA INITIO KIT | ALKERMES INC | N209830 | June 29, 2018 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10112903 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 675MG/2.4ML (281.25MG/ML) | ARISTADA INITIO KIT | ALKERMES INC | N209830 | June 29, 2018 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 8796276 | June 24, 2030 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10226458 | March 19, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10226458 | March 19, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10226458 | March 19, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10226458 | March 19, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9034867 | Nov. 7, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9034867 | Nov. 7, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9034867 | Nov. 7, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9034867 | Nov. 7, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12629366 | Dec. 6, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12629366 | Dec. 6, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12629366 | Dec. 6, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12629366 | Dec. 6, 2032 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11097006 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12311027 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11097006 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12311027 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11097006 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12311027 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11097006 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12311027 | Sept. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9193685 | Oct. 24, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9193685 | Oct. 24, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9193685 | Oct. 24, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9193685 | Oct. 24, 2033 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10238651 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10813928 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11406632 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9452131 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10238651 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10813928 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11406632 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9452131 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10238651 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10813928 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INJECTION |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11406632 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9452131 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10238651 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10813928 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11406632 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9452131 | March 19, 2035 | TREATMENT OF SCHIZOPHRENIA BY RAPID AND CONTINUOUS INTRAMUSCULAR INJECTION |
| 675MG/2.4ML (281.25MG/ML) | ARISTADA INITIO KIT | ALKERMES INC | N209830 | June 29, 2018 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10849894 | Aug. 17, 2035 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11273158 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 1064MG/3.9ML (272.82MG/ML) | ARISTADA | ALKERMES INC | N207533 | June 5, 2017 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12251381 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11273158 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 441MG/1.6ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12251381 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11273158 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 662MG/2.4ML (275.83MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12251381 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11273158 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 882MG/3.2ML (275.63MG/ML) | ARISTADA | ALKERMES INC | N207533 | Oct. 5, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12251381 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 675MG/2.4ML (281.25MG/ML) | ARISTADA INITIO KIT | ALKERMES INC | N209830 | June 29, 2018 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11273158 | April 6, 2039 | TREATMENT OF SCHIZOPHRENIA |
| 675MG/2.4ML (281.25MG/ML) | ARISTADA INITIO KIT | ALKERMES INC | N209830 | June 29, 2018 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 12251381 | April 6, 2039 | TREATMENT OF 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 | PARTIAL AGONIST | Ki | 9.47 | DRUG LABEL | DRUG LABEL | |||
| 5-hydroxytryptamine receptor 1A | GPCR | PARTIAL AGONIST | Ki | 8.77 | DRUG LABEL | DRUG LABEL | |||
| 5-hydroxytryptamine receptor 2A | GPCR | ANTAGONIST | Ki | 8.47 | DRUG LABEL | DRUG LABEL | |||
| 5-hydroxytryptamine receptor 1B | GPCR | AGONIST | Ki | 6.10 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 7 | GPCR | Ki | 7.41 | DRUG LABEL | |||||
| D(3) dopamine receptor | GPCR | Ki | 9.10 | DRUG LABEL | |||||
| Histamine H1 receptor | GPCR | Ki | 7.22 | DRUG LABEL | |||||
| D(4) dopamine receptor | GPCR | Ki | 7.36 | DRUG LABEL | |||||
| 5-hydroxytryptamine receptor 2C | GPCR | Ki | 7.82 | DRUG LABEL | |||||
| 5-hydroxytryptamine receptor 1D | GPCR | AGONIST | Ki | 7.20 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 2A | GPCR | AGONIST | Ki | 7.70 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 7 | GPCR | AGONIST | Ki | 7.80 | IUPHAR | ||||
| D(4) dopamine receptor | GPCR | ANTAGONIST | Ki | 7.30 | IUPHAR | ||||
| 5-hydroxytryptamine receptor 6 | GPCR | AGONIST | Ki | 6.80 | IUPHAR | ||||
| D(2) dopamine receptor | GPCR | AGONIST | Ki | 9.70 | IUPHAR |
External reference:
| ID | Source |
|---|---|
| B786J7A343 | UNII |
| D10364 | KEGG_DRUG |
| 4034891 | VANDF |
| C4056439 | UMLSCUI |
| CHEMBL2219425 | ChEMBL_ID |
| 49831411 | PUBCHEM_CID |
| DB14185 | DRUGBANK_ID |
| C000603935 | MESH_SUPPLEMENTAL_RECORD_UI |
| 1673265 | RXNORM |
| 236432 | MMSL |
| 31226 | MMSL |
| 016489 | NDDF |
| 017628 | NDDF |
| 715182007 | SNOMEDCT_US |
| CHEBI:90930 | CHEBI |
| B786J7A343 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ARISTADA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65757-401 | INJECTION, SUSPENSION, EXTENDED RELEASE | 441 mg | INTRAMUSCULAR | NDA | 29 sections |
| ARISTADA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65757-402 | INJECTION, SUSPENSION, EXTENDED RELEASE | 662 mg | INTRAMUSCULAR | NDA | 29 sections |
| ARISTADA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65757-403 | INJECTION, SUSPENSION, EXTENDED RELEASE | 882 mg | INTRAMUSCULAR | NDA | 29 sections |
| ARISTADA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65757-404 | INJECTION, SUSPENSION, EXTENDED RELEASE | 1064 mg | INTRAMUSCULAR | NDA | 29 sections |
| ARISTADA INITIO | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65757-500 | INJECTION, SUSPENSION, EXTENDED RELEASE | 675 mg | INTRAMUSCULAR | NDA | 29 sections |