AI ASSISTANT
Ask DrugCentral
Explore drug properties, targets, and indications with answers grounded in DrugCentral.
Powered by DrugCentral + retrieval-augmented AIYour question
Ask in your own words. Each question is answered independently.
Explore sample questions
Select a question to fill the editor, then ask it or make it your own.
DrugCentral answer
Your answer will appear here. Open linked drug cards in a new tab to explore the source details.
About Ask DrugCentral
Ask DrugCentral helps you explore drug properties, biological targets, and indications using natural language. Sample questions offer starting points, and linked drug cards let you check the underlying records.
General architecture
- Ask a questionThe browser sends your question to the same-origin Django chat API.
- Retrieve and generateThe API forwards the question to the configured DrugCentral retrieval-augmented generation (RAG) service, which returns an AI-generated answer.
- Explore the answerThe app resolves cited drug-card names and displays the answer with links to drug records.
Using the assistant
Each request is independent; previous questions are not sent as conversation history. You can edit a sample before submitting, retry a failed request, or switch back to normal search. Drug links open in a new tab so your question and answer stay available.
Answers may contain mistakes or omit information. Verify details against DrugCentral records and original sources.
AI can make mistakes. Verify answers against the original sources before relying on them.
lumateperone 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tranquillizers, neuroleptics, 4'-fluoro-4-piperidinobutyrophenone derivatives | 5358 | 313368-91-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
The mechanism of action of lumateperone in the treatment of schizophrenia is unknown. However, the efficacy of lumateperone could be mediated through a combination of antagonist activity at central serotonin 5-HT2A receptors and postsynaptic antagonist activity at central dopamine D2 receptors.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.30 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PAK4,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK | 52 | |||
| kinase-selectivity-class | AKT3,AXL,CAMK2D,EIF2AK3,PDK4,PRKCD,SIK2,STK33 | 8 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Dec. 20, 2019 | FDA | INTRA-CELLULAR |
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 |
|---|---|---|---|---|---|---|
| Mania | 408.63 | 45.29 | 108 | 5792 | 14016 | 90608531 |
| Dizziness | 401.86 | 45.29 | 319 | 5581 | 588965 | 90033582 |
| Tardive dyskinesia | 342.15 | 45.29 | 89 | 5811 | 10841 | 90611706 |
| Sedation | 310.69 | 45.29 | 117 | 5783 | 48054 | 90574493 |
| Akathisia | 264.70 | 45.29 | 73 | 5827 | 11086 | 90611461 |
| Burning sensation | 239.73 | 45.29 | 105 | 5795 | 63347 | 90559200 |
| Somnolence | 208.37 | 45.29 | 143 | 5757 | 208941 | 90413606 |
| Suicidal ideation | 141.81 | 45.29 | 77 | 5823 | 73778 | 90548769 |
| Skin burning sensation | 138.55 | 45.29 | 51 | 5849 | 19560 | 90602987 |
| Nausea | 132.70 | 45.29 | 248 | 5652 | 1110068 | 89512479 |
| Electric shock sensation | 123.73 | 45.29 | 27 | 5873 | 1543 | 90621004 |
| Headache | 121.14 | 45.29 | 207 | 5693 | 862539 | 89760008 |
| Performance status decreased | 106.06 | 45.29 | 29 | 5871 | 4251 | 90618296 |
| Irritability | 99.89 | 45.29 | 48 | 5852 | 35614 | 90586933 |
| Hypomania | 89.07 | 45.29 | 30 | 5870 | 8867 | 90613680 |
| Tremor | 88.70 | 45.29 | 76 | 5824 | 153097 | 90469450 |
| Dyskinesia | 86.91 | 45.29 | 44 | 5856 | 36490 | 90586057 |
| Feeling abnormal | 80.98 | 45.29 | 75 | 5825 | 167160 | 90455387 |
| Tachyphrenia | 73.72 | 45.29 | 18 | 5882 | 1688 | 90620859 |
| Temperature regulation disorder | 71.18 | 45.29 | 29 | 5871 | 14550 | 90607997 |
| Unevaluable event | 70.21 | 45.29 | 44 | 5856 | 54804 | 90567743 |
| Psychotic disorder | 63.89 | 45.29 | 34 | 5866 | 31196 | 90591351 |
| Feeling drunk | 63.70 | 45.29 | 20 | 5880 | 4738 | 90617809 |
| Migraine | 62.13 | 45.29 | 69 | 5831 | 190323 | 90432224 |
| Feeling hot | 60.59 | 45.29 | 46 | 5854 | 77962 | 90544585 |
| Hallucination, auditory | 55.58 | 45.29 | 25 | 5875 | 15950 | 90606597 |
| Pseudostroke | 55.32 | 45.29 | 9 | 5891 | 100 | 90622447 |
| Anxiety | 54.93 | 45.29 | 83 | 5817 | 309689 | 90312858 |
| Extrapyramidal disorder | 48.85 | 45.29 | 23 | 5877 | 16280 | 90606267 |
| Dystonia | 48.17 | 45.29 | 23 | 5877 | 16796 | 90605751 |
| Neuroleptic malignant syndrome | 47.41 | 45.29 | 22 | 5878 | 15074 | 90607473 |
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 |
|---|---|---|---|---|---|---|
| Mania | 195.56 | 52.83 | 54 | 2141 | 10493 | 42608647 |
| Akathisia | 168.61 | 52.83 | 48 | 2147 | 10403 | 42608737 |
| Tardive dyskinesia | 144.79 | 52.83 | 39 | 2156 | 6885 | 42612255 |
| Sedation | 118.25 | 52.83 | 48 | 2147 | 30427 | 42588713 |
| Dizziness | 113.66 | 52.83 | 97 | 2098 | 249157 | 42369983 |
| Burning sensation | 102.21 | 52.83 | 39 | 2156 | 20974 | 42598166 |
| Suicidal ideation | 88.32 | 52.83 | 45 | 2150 | 48116 | 42571024 |
| Headache | 77.36 | 52.83 | 77 | 2118 | 239292 | 42379848 |
| Somnolence | 64.11 | 52.83 | 55 | 2140 | 141050 | 42478090 |
| Hypomania | 61.30 | 52.83 | 16 | 2179 | 2492 | 42616648 |
| Hallucination, auditory | 56.14 | 52.83 | 23 | 2172 | 14841 | 42604299 |
| Psychotic disorder | 55.54 | 52.83 | 28 | 2167 | 29180 | 42589960 |
| Anxiety | 55.41 | 52.83 | 47 | 2148 | 118513 | 42500627 |
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 |
|---|---|---|---|---|---|---|
| Tardive dyskinesia | 304.34 | 42.34 | 77 | 4424 | 13502 | 110571296 |
| Dizziness | 262.84 | 42.34 | 220 | 4281 | 697973 | 109886825 |
| Mania | 253.81 | 42.34 | 73 | 4428 | 20723 | 110564075 |
| Akathisia | 208.45 | 42.34 | 60 | 4441 | 17053 | 110567745 |
| Burning sensation | 184.49 | 42.34 | 78 | 4423 | 69134 | 110515664 |
| Suicidal ideation | 146.66 | 42.34 | 73 | 4428 | 93864 | 110490934 |
| Sedation | 145.00 | 42.34 | 66 | 4435 | 69617 | 110515181 |
| Headache | 110.67 | 42.34 | 156 | 4345 | 882221 | 109702577 |
| Somnolence | 105.36 | 42.34 | 91 | 4410 | 297358 | 110287440 |
| Nausea | 92.73 | 42.34 | 173 | 4328 | 1235517 | 109349281 |
| Irritability | 89.15 | 42.34 | 42 | 4459 | 47767 | 110537031 |
| Psychotic disorder | 83.61 | 42.34 | 41 | 4460 | 50896 | 110533902 |
| Performance status decreased | 77.49 | 42.34 | 23 | 4478 | 7243 | 110577555 |
| Skin burning sensation | 76.57 | 42.34 | 30 | 4471 | 21795 | 110563003 |
| Hypomania | 69.79 | 42.34 | 23 | 4478 | 10187 | 110574611 |
| Feeling abnormal | 69.42 | 42.34 | 58 | 4443 | 180653 | 110404145 |
| Tremor | 65.73 | 42.34 | 59 | 4442 | 202173 | 110382625 |
| Hallucination, auditory | 61.20 | 42.34 | 27 | 4474 | 26370 | 110558428 |
| Anxiety | 56.83 | 42.34 | 70 | 4431 | 345008 | 110239790 |
| Insomnia | 54.38 | 42.34 | 70 | 4431 | 360520 | 110224278 |
| Electric shock sensation | 53.42 | 42.34 | 13 | 4488 | 1931 | 110582867 |
| Feeling hot | 49.65 | 42.34 | 36 | 4465 | 91070 | 110493728 |
| Dyskinesia | 49.40 | 42.34 | 29 | 4472 | 51417 | 110533381 |
| Temperature regulation disorder | 46.28 | 42.34 | 18 | 4483 | 12808 | 110571990 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N05AD10 | NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Butyrophenone derivatives |
| FDA EPC | N0000175430 | Atypical Antipsychotic |
| CHEBI has role | CHEBI:35476 | antipsychotic agent |
| CHEBI has role | CHEBI:35469 | antidepressant |
Related Drugs by ATC class:
N05AD Butyrophenone derivatives 8 drugs
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 | 8.98 | Basic |
| pKa2 | 4.65 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 9199995 | March 12, 2029 | MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 9199995 | March 12, 2029 | MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN SCHIZOPHRENIA |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 9199995 | March 12, 2029 | MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 9199995 | March 12, 2029 | MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN SCHIZOPHRENIA |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 9199995 | March 12, 2029 | MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 9199995 | March 12, 2029 | MODULATION OF 5-HYDROXYTRYPTAMINE 2 RECEPTOR ACTIVITY IN SCHIZOPHRENIA |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 10117867 | May 27, 2029 | TREATMENT OF BIPOLAR DEPRESSION |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 10117867 | May 27, 2029 | TREATMENT OF BIPOLAR DEPRESSION |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 10117867 | May 27, 2029 | TREATMENT OF BIPOLAR DEPRESSION |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 8598119 | Dec. 28, 2029 | TREATMENT OF SCHIZOPHRENIA |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF BIPOLAR DEPRESSION |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF BIPOLAR DEPRESSION |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF BIPOLAR DEPRESSION |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | RE48839 | Aug. 19, 2033 | TREATMENT OF SCHIZOPHRENIA |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11026951 | Dec. 3, 2034 | TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 9956227 | Dec. 3, 2034 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11026951 | Dec. 3, 2034 | TREATMENT OF BIPOLAR DISORDER I, BIPOLAR DISORDER II, OR BIPOLAR DEPRESSION |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 9956227 | Dec. 3, 2034 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 10960009 | Dec. 3, 2034 | TREATMENT OF SCHIZOPHRENIA |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11026951 | Dec. 3, 2034 | TREATMENT OF BIPOLAR I DISORDER, BIPOLAR II DISORDER, OR BIPOLAR DEPRESSION |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 9956227 | Dec. 3, 2034 | TREATMENT OF SCHIZOPHRENIA WITH IMPROVEMENT IN RESIDUAL SYMPTOMS OF SCHIZOPHRENIA |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12409176 | March 15, 2039 | TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12409176 | March 15, 2039 | TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12409176 | March 15, 2039 | TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 10695345 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11052084 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11052084 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11052084 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 10695345 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11052084 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11052084 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11052084 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 10695345 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11690842 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11806348 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12070459 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12070459 | Aug. 30, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS, ADJUNCTIVE TO ANTIDEPRESSANT TREATMENT |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12070459 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12128043 | Aug. 30, 2039 | TREATMENT OF BIPOLAR DEPRESSION MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12128043 | Aug. 30, 2039 | TREATMENT OF SCHIZOPHRENIA MEDIATED BY THE 5-HT2A RECEPTOR, SEROTONIN TRANSPORTER, AND/OR DOPAMINE D1/D2 SIGNALING PATHWAYS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11980617 | Oct. 27, 2039 | TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11980617 | Oct. 27, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, INCLUDING TREATMENT RESISTANT MAJOR DEPRESSIVE DISORDER |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11980617 | Oct. 27, 2039 | TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 11980617 | Oct. 27, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, INCLUDING TREATMENT RESISTANT MAJOR DEPRESSIVE DISORDER |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11980617 | Oct. 27, 2039 | TREATMENT OF BIPOLAR DISORDER OR BIPOLAR DEPRESSION, INCLUDING ASSOCIATED DEPRESSIVE EPISODES |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 11980617 | Oct. 27, 2039 | TREATMENT OF MAJOR DEPRESSIVE DISORDER ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, INCLUDING TREATMENT RESISTANT MAJOR DEPRESSIVE DISORDER |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12090155 | July 7, 2040 | TREATMENT OF DEPRESSIVE EPISODES OR MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR II DISORDER |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF BIPOLAR DEPRESSION BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF BIPOLAR DISORDER |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF MAJOR DEPRESSIVE DISORDER, ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, OR ADJUNCTIVE TO ANTIDEPRESSANT THERAPY BY INHIBITING THE 5-HT2A RECEPTOR AND/OR SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF SCHIZOPHRENIA BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF SCHIZOPHRENIA |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF BIPOLAR DEPRESSION BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF BIPOLAR DISORDER |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF MAJOR DEPRESSIVE DISORDER, ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, OR ADJUNCTIVE TO ANTIDEPRESSANT THERAPY BY INHIBITING THE 5-HT2A RECEPTOR AND/OR SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF SCHIZOPHRENIA BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF SCHIZOPHRENIA |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF BIPOLAR DEPRESSION BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF BIPOLAR DISORDER |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF MAJOR DEPRESSIVE DISORDER, ADJUNCTIVE TO ANTIDEPRESSANT THERAPY, OR ADJUNCTIVE TO ANTIDEPRESSANT THERAPY BY INHIBITING THE 5-HT2A RECEPTOR AND/OR SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | 12122792 | Dec. 10, 2040 | TREATMENT OF SCHIZOPHRENIA BY INHIBITING THE 5-HT2A RECEPTOR, INHIBITING THE SEROTONIN TRANSPORTER, AND/OR MODULATING DOPAMINE D2 RECEPTOR FUNCTION, OR TREATMENT OF SCHIZOPHRENIA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | Nov. 5, 2028 | ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | Nov. 5, 2028 | ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | Nov. 5, 2028 | ADJUNCTIVE THERAPY TO ANTIDEPRESSANTS FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADULTS |
| EQ 10.5MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | April 24, 2029 | UPDATES TO SECTION 14 OF THE PRESCRIBING INFORMATION BASED ON RESULTS OF A CLINICAL STUDY |
| EQ 21MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | April 22, 2022 | RX | CAPSULE | ORAL | April 24, 2029 | UPDATES TO SECTION 14 OF THE PRESCRIBING INFORMATION BASED ON RESULTS OF A CLINICAL STUDY |
| EQ 42MG BASE | CAPLYTA | INTRA-CELLULAR | N209500 | Dec. 20, 2019 | RX | CAPSULE | ORAL | April 24, 2029 | UPDATES TO SECTION 14 OF THE PRESCRIBING INFORMATION BASED ON RESULTS OF A CLINICAL STUDY |
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 | 7.49 | DRUG LABEL | DRUG LABEL | |||
| 5-hydroxytryptamine receptor 2A | GPCR | ANTAGONIST | Ki | 9.26 | DRUG LABEL | DRUG LABEL | |||
| Alpha-1A adrenergic receptor | GPCR | Ki | 7.14 | CHEMBL | |||||
| D(4) dopamine receptor | GPCR | Ki | 6.97 | CHEMBL | |||||
| Alpha-1B adrenergic receptor | GPCR | Ki | 7.51 | CHEMBL | |||||
| 5-hydroxytryptamine receptor 1A | GPCR | Ki | 5.83 | CHEMBL | |||||
| D(1A) dopamine receptor | GPCR | ANTAGONIST | Ki | 7.38 | DRUG LABEL | ||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 7.48 | DRUG LABEL | |||||
| 5-hydroxytryptamine receptor 2C | GPCR | Ki | 6.76 | CHEMBL | |||||
| D(2) dopamine receptor | GPCR | Ki | 7.50 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4039112 | VANDF |
| CHEBI:755315 | CHEBI |
| 92S | PDB_CHEM_ID |
| CHEMBL3306803 | ChEMBL_ID |
| D11169 | KEGG_DRUG |
| C000705749 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9099 | IUPHAR_LIGAND_ID |
| DB06077 | DRUGBANK_ID |
| 838463000 | SNOMEDCT_US |
| 838474009 | SNOMEDCT_US |
| C4305843 | UMLSCUI |
| CHEMBL3233142 | ChEMBL_ID |
| 10156 | INN_ID |
| 1187020-80-9 | SECONDARY_CAS_RN |
| 328648 | MMSL |
| 37890 | MMSL |
| d09477 | MMSL |
| 21302490 | PUBCHEM_CID |
| 018246 | NDDF |
| 018247 | NDDF |
| 70BSQ12069 | UNII |
| 2275602 | RXNORM |
| 70BSQ12069 | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| CAPLYTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72060-110 | CAPSULE | 10.50 mg | ORAL | NDA | 32 sections |
| CAPLYTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72060-121 | CAPSULE | 21 mg | ORAL | NDA | 32 sections |
| CAPLYTA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72060-142 | CAPSULE | 42 mg | ORAL | NDA | 32 sections |