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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
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

Molecule

Description

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:

Dose	Unit	Route
60	mg	O

ADMET properties:

None

Approvals:

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Date	Agency	Company	Orphan
March 25, 2020	PMDA	Sumitomo Dainippon Pharma Co., Ltd.
Oct. 28, 2010	FDA	SUNOVION PHARMS INC

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FDA Adverse Event Reporting System (Female)

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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	1222.69	21.45	245	12550	2834	63473393
Anosognosia	1195.72	21.45	242	12553	2954	63473273
Sexual dysfunction	1177.43	21.45	252	12543	4107	63472120
Disturbance in social behaviour	1119.13	21.45	238	12557	3755	63472472
Metabolic disorder	1071.77	21.45	251	12544	6252	63469975
Personality change	935.74	21.45	228	12567	6745	63469482
Dystonia	902.13	21.45	255	12540	13564	63462663
Dyskinesia	830.99	21.45	292	12503	31710	63444517
Sedation	808.94	21.45	301	12494	38508	63437719
Suicide attempt	680.80	21.45	302	12493	60616	63415611

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FDA Adverse Event Reporting System (Male)

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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	367.59	30.05	72	5747	901	34950211
Blood prolactin abnormal	337.50	30.05	67	5752	902	34950210
Disturbance in social behaviour	288.90	30.05	66	5753	1785	34949327
Metabolic disorder	247.61	30.05	69	5750	4214	34946898
Sexual dysfunction	242.46	30.05	74	5745	6229	34944883
Dystonia	229.45	30.05	81	5738	10764	34940348
Dyskinesia	194.49	30.05	88	5731	22325	34928787
Personality change	179.28	30.05	56	5763	5083	34946029
Sedation	168.16	30.05	78	5741	20928	34930184
Suicide attempt	117.68	30.05	76	5743	39040	34912072

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FDA Adverse Event Reporting System (Geriatric)

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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	1415.45	21.41	280	14439	3321	79726348
Anosognosia	1415.12	21.41	282	14437	3482	79726187
Disturbance in social behaviour	1285.39	21.41	273	14446	4697	79724972
Sexual dysfunction	1254.24	21.41	290	14429	7473	79722196
Metabolic disorder	1164.99	21.41	282	14437	8888	79720781
Personality change	1041.06	21.41	263	14456	9907	79719762
Dystonia	971.29	21.41	292	14427	21107	79708562
Dyskinesia	883.76	21.41	326	14393	44447	79685222
Sedation	847.59	21.41	329	14390	51566	79678103
Suicide attempt	717.55	21.41	335	14384	82597	79647072

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N05AE05	NERVOUS SYSTEM PSYCHOLEPTICS ANTIPSYCHOTICS Indole derivatives
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
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

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

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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

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🐶 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)

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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
120MG	LATUDA	SUNOVION PHARMS INC	N200603	April 26, 2012	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	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

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
D(2) dopamine receptor	GPCR	P14416	DRD2_HUMAN	ANTAGONIST	Ki	9.00	DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 2A	GPCR	P28223	5HT2A_HUMAN	ANTAGONIST	Ki	9.33	DRUG LABEL	DRUG LABEL
5-hydroxytryptamine receptor 7	GPCR	P34969	5HT7R_HUMAN	ANTAGONIST	Ki	9.31	DRUG LABEL
Alpha-2C adrenergic receptor	GPCR	P18825	ADA2C_HUMAN		Ki	7.97	DRUG LABEL
Alpha-2A adrenergic receptor	GPCR	P08913	ADA2A_HUMAN		Ki	7.39	DRUG LABEL
5-hydroxytryptamine receptor 1A	GPCR	P08908	5HT1A_HUMAN		Ki	8.20	DRUG LABEL
D(2) dopamine receptor	GPCR		DRD2_RAT	ANTAGONIST	Ki	8.77	IUPHAR
5-hydroxytryptamine receptor 1A	GPCR		5HT1A_RAT	AGONIST	Ki	8.17	IUPHAR
5-hydroxytryptamine receptor 2A	GPCR		5HT2A_RAT	ANTAGONIST	Ki	8.69	IUPHAR

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External reference:

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ID	Source
013606	NDDF
013607	NDDF
1040027	RXNORM
177747	MMSL
213046	PUBCHEM_CID
22IC88528T	UNII
27589	MMSL
365355	MMSL
367514-88-3	SECONDARY_CAS_RN
4030294	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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	13668-464	TABLET, FILM COATED	20 mg	ORAL	ANDA	24 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	13668-464	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	13668-465	TABLET, FILM COATED	40 mg	ORAL	ANDA	24 sections

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