Lurasidone

Overview

Lurasidone is an atypical antipsychotic developed by Dainippon Sumitomo Pharma. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 29, 2010 and is currently pending approval for the treatment of bipolar disorder in the United States.

Indication

Lurasidone is indicated for the treatment of schizophrenia in patients ≥13 years old. It is also indicated as a monotherapy for the treatment of bipolar depression in patients ≥10 years old, or in combination with lithium or valproate for the treatment of bipolar depression in adults.

Associated Conditions

Depression, Bipolar
Schizophrenia

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Lurasidone Non-Interventional Study in Schizophrenia Patients	2024/07/30	NCT06527885	N/A	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A
Sequential Multiple Assignment Randomized Trial for Bipolar Depression	2024/05/30	NCT06433635	Phase 4	Recruiting	Massachusetts General Hospital
Sleep Quality, Cognitive Performance, and Computerized Cognitive Training	2024/03/25	NCT06328140	N/A	Withdrawn	George West Mental Health Foundation d/b/a Skyland Trail
Chinese Longitudinal and Systematic Study of Bioplar Disorder	2022/07/29	NCT05480150	Not Applicable	Recruiting	First Affiliated Hospital of Zhejiang University
Impact of Structural and Myelin Abnormalities on Cognitive Impairments in Recent-onset Schizophrenia - Before and After Lurasidone Treatment (MARYLU)	2022/04/28	NCT05351736	Phase 4	Recruiting	Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine	2022/01/28	NCT05213143	Phase 4	Terminated	Sumitomo Pharma (Suzhou) Co., Ltd.
The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia	2021/08/18	NCT05011669	Phase 4	Completed	Sumitomo Pharma (Suzhou) Co., Ltd.
The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients	2020/06/16	NCT04432688	N/A	Completed	Sumitomo Pharma (Suzhou) Co., Ltd.
A Study of Lurasidone Compared With Placebo for the Treatment of Bipolar I Depression	2020/05/12	NCT04383691	Phase 3	Terminated	Sumitomo Pharma (Suzhou) Co., Ltd.
Observational Study on the Effect of Switch to Lurasidone in Subjects With Schizophrenia"	2020/03/18	NCT04312503	N/A	Completed	Aziende Chimiche Riunite Angelini Francesco S.p.A

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
lurasidone hydrochloride	Ascend Laboratories, LLC	67877-638	ORAL	20 mg in 1 1	1/5/2023
Lurasidone hydrochloride	Zydus Lifesciences Limited	70771-1737	ORAL	80 mg in 1 1	9/27/2023
Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	62332-497	ORAL	80 mg in 1 1	1/25/2023
Latuda	Sumitomo Pharma America, Inc.	63402-304	ORAL	40 mg in 1 1	7/21/2023
Lurasidone Hydrochloride	Cipla USA, Inc.	69097-939	ORAL	60 mg in 1 1	1/19/2023
Lurasidone hydrochloride	Dr. Reddys Laboratories Inc	43598-353	ORAL	60 mg in 1 1	12/6/2022
Lurasidone Hydrochloride	Alembic Pharmaceuticals Inc.	62332-496	ORAL	60 mg in 1 1	1/25/2023
lurasidone hydrochloride	Macleods Pharmaceuticals Limited	33342-419	ORAL	20 mg in 1 1	6/26/2023
Lurasidone Hydrochloride	Torrent Pharmaceuticals Limited	13668-464	ORAL	20 mg in 1 1	3/20/2023
Lurasidone Hydrochloride	Alembic Pharmaceuticals Limited	46708-495	ORAL	40 mg in 1 1	1/25/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Latuda	Aziende Chimiche Riunite Angelini Francesco S.p.A.,Viale Amelia 70,00181,Roma,Italy	Authorised	3/21/2014

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
LATUDA TABLET 20MG	Bushu Pharmaceuticals Ltd (Kawagoe Factory), OLIC (Thailand) Ltd (Primary and Secondary Packager)	SIN16346P	TABLET, FILM COATED	20mg	10/12/2021
LATUDA TABLET 40MG	Bushu Pharmaceuticals Ltd (Kawagoe Factory), OLIC (Thailand) Ltd (Primary and Secondary Packager)	SIN15088P	TABLET, COATED	40mg	9/14/2016
LATUDA TABLET 80MG	Bushu Pharmaceuticals Ltd (Kawagoe Factory), OLIC (Thailand) Ltd (Primary and Secondary Packager)	SIN15089P	TABLET, COATED	80 mg	9/14/2016

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Lurasidone Hydrochloride Tablets	扬子江药业集团南京海陵药业有限公司	国药准字H20213935	化学药品	片剂	12/14/2021
Lurasidone Hydrochloride Tablets	江西施美药业股份有限公司	国药准字H20249387	化学药品	片剂	11/15/2024
Lurasidone Hydrochloride Tablets	齐鲁制药（海南）有限公司	国药准字H20234215	化学药品	片剂	9/28/2023
Lurasidone Hydrochloride Tablets	重庆药友制药有限责任公司	国药准字H20243106	化学药品	片剂	1/30/2024
Lurasidone Hydrochloride Tablets	山东京卫制药有限公司	国药准字H20244483	化学药品	片剂	7/22/2024
Lurasidone Hydrochloride Tablets	DR. REDDY'S LABORATORIES LIMITED	国药准字HJ20230104	化学药品	片剂	9/5/2023
Lurasidone Hydrochloride Tablets	Sumitomo Pharma America, Inc.	国药准字HJ20190021	化学药品	片剂	8/10/2023
Lurasidone Hydrochloride Tablets	Sumitomo Pharma America, Inc.	国药准字HJ20191009	化学药品	片剂	8/10/2023
Lurasidone Hydrochloride Tablets	齐鲁制药（海南）有限公司	国药准字H20234213	化学药品	片剂	9/28/2023
Lurasidone Hydrochloride Tablets	常州制药厂有限公司	国药准字H20244450	化学药品	片剂	7/16/2024

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
LATUDA TABLETS 80MG	N/A	DKSH Hong Kong Limited	N/A	N/A	11/4/2016

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PHARMACOR LURASIDONE lurasidone hydrochloride 20 mg film-coated tablet bottle	324023	Pharmacor Pty Ltd	Medicine	A	10/16/2020
APO-LURASIDONE lurasidone hydrochloride 40 mg film-coated tablet blister pack	321646	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/24/2020
APO-LURASIDONE lurasidone hydrochloride 80 mg film-coated tablet blister pack	321647	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	6/24/2020
LATUDA lurasidone hydrochloride 20 mg film-coated tablet blister pack	206654	Servier Laboratories (Aust) Pty Ltd	Medicine	A	4/16/2014
PHARMACOR LURASIDONE lurasidone hydrochloride 40 mg film-coated tablet blister pack	324021	Pharmacor Pty Ltd	Medicine	A	10/16/2020
LURASIDONE LUPIN lurasidone hydrochloride 80 mg film-coated tablet blister pack	317202	Lupin Australia Pty Limited	Medicine	A	5/7/2020
MSN-LURASIDONE lurasidone hydrochloride 80 mg tablet blister pack	317303	Accelagen Pty Ltd	Medicine	A	3/17/2020
LURASIDONE SUN lurasidone hydrochloride 40 mg film-coated tablet blister pack	330268	Sun Pharma ANZ Pty Ltd	Medicine	A	11/12/2020
LURACOR lurasidone hydrochloride 20 mg film-coated tablet bottle	324031	Pharmacor Pty Ltd	Medicine	A	10/16/2020
LURASIDONE-WGR lurasidone hydrochloride 80 mg film-coated tablet blister pack	437290	GM Pharma International Pty Ltd	Medicine	A	4/17/2024

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