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Lumateperone
Caplyta (lumateperone) is a small molecule pharmaceutical. Lumateperone was first approved as Caplyta on 2019-12-20. It is used to treat schizophrenia in the USA. It is known to target 5-hydroxytryptamine receptor 2A, sodium-dependent serotonin transporter, and D(2) dopamine receptor.
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FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
mental disordersD001523
Trade Name
FDA
EMA
Caplyta
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Lumateperone tosylate
Tradename
Company
Number
Date
Products
CAPLYTAIntra-Cellular TherapiesN-209500 RX2019-12-20
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
caplytaNew Drug Application2022-09-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
schizophreniaEFO_0000692D012559F20
Agency Specific
FDA
EMA
Expiration
Code
LUMATEPERONE TOSYLATE, CAPLYTA, INTRA-CELLULAR
2024-12-20NCE
2024-12-17I-882
Patent Expiration
Patent
Expires
Flag
FDA Information
Lumateperone Tosylate, Caplyta, Intra-Cellular
106953452039-08-30DPU-543, U-814
110520842039-08-30DPU-3362, U-3363
99562272034-12-03U-2714
109600092034-12-03U-814
110269512034-12-03U-3274, U-3364
RE488392029-12-28U-814, U-3271
85981192029-12-28U-543
86480772029-12-01DS, DP
96160612029-05-27DP
101178672029-05-27U-3271
91999952029-03-12U-2713
95869602029-03-12DS, DP
RE488252029-02-12DP
104649382028-03-12DP
ATC Codes
N: Nervous system drugs
— N05: Psycholeptics
— N05A: Antipsychotics
— N05AD: Butyrophenone derivatives, antipsychotics
— N05AD10: Lumateperone
HCPCS
No data
Clinical
Clinical Trials
20 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F20233——8
Bipolar disorderD001714EFO_0000289F30.9——4——4
Major depressive disorderD003865EFO_0003761F22——4——4
Alzheimer diseaseD000544EFO_0000249F03111——2
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Borderline personality disorderD001883HP_0012076F60.3—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameLUMATEPERONE
INNlumateperone
Description
Lumateperone, sold under the brand name Caplyta, is an atypical antipsychotic medication of the butyrophenone class. It is approved for the treatment of schizophrenia as well as bipolar depression, as either monotherapy or adjunctive therapy (with lithium or valproate). It is developed by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb. Lumateperone was approved for medical use in the United States in December 2019 with an initial indication for schizophrenia, and became available in February 2020. It has since demonstrated efficacy in bipolar depression and received FDA approval in December 2021 for depressive episodes associated with both bipolar I and II disorders.
Classification
Small molecule
Drug classantianxiety agents/neuroleptics (4'-fluoro-4-piperidinobutyrophenone derivatives)
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CN1CCN2c3c(cccc31)[C@@H]1CN(CCCC(=O)c3ccc(F)cc3)CC[C@@H]12
Identifiers
PDB—
CAS-ID313368-91-1
RxCUI—
ChEMBL IDCHEMBL3306803
ChEBI ID—
PubChem CID9821941
DrugBankDB06077
UNII ID70BSQ12069 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
HTR2A
HTR2A
SLC6A4
SLC6A4
DRD2
DRD2
Organism
Homo sapiens
Gene name
HTR2A
Gene synonyms
HTR2
NCBI Gene ID
3356
Protein name
5-hydroxytryptamine receptor 2A
Protein synonyms
5-HT2 receptor, 5-hydroxytryptamine (serotonin) receptor 2A, G protein-coupled, serotonin 5-HT-2A receptor, Serotonin receptor 2A
Uniprot ID
Q5T8C0
Mouse ortholog
Htr2a (15558)
5-hydroxytryptamine receptor 2A (P35363)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 183 documents
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Safety
Black-box Warning
Black-box warning for: Caplyta
Adverse Events
Top Adverse Reactions
Mock data
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375 adverse events reported
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