Perospirone Hydrochloride Hydrate

Perospirone hydrochloride hydrate was approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on December 22, 2000. It was developed and marketed as Lullan® by Dainippon Sumitomo Pharma in Japan.

Perospirone is an antagonist of multiple dopamine and serotonin receptors. It is usually used to treat schizophrenia and acute cases of bipolar mania.

Lullan® is available as tablet for oral use, containing 4, 8 or 16 mg of free Perospirone. The recommended dose is 4 mg three times daily taken after meals, and daily dose should not exceed 48mg.

Index：

General Information

Update Date：2016-03-23

Drug Name：
Perospirone Hydrochloride Hydrate
Research Code：
SM-9018
Trade Name：
Lullan®
MOA：
Dopamine and serotonin receptors
Indication：
Schizophrenia; Bipolar mania
Status：
Approved
Company：
Dainippon Sumitomo (Originator)
Sales：
ATC Code：
N05
Approved Countries or Area

Update Date：2015-07-29

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2000-12-22 First approval Lullan Schizophrenia,Bipolar mania Tablet Eq. 4 mg/8 mg/16 mg Perospirone Dainippon Sumitomo
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Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2013-04-11 Marketing approval Schizophrenia,Bipolar mania Tablet 4 mg 丽珠集团丽珠制药厂
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Chemical Structure

Update Date：2015-08-27

Molecular Weight 499.07
Formula C23H30N4O2S • HCl • 2H2O
CAS No. 150915-41-6 (Perospirone );
192052-81-6 (Perospirone HCl Dihydrate);
Chemical Name cis-N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]butyl]cyclohexane-1,2-dicarboximide
Perospirone （Free Acid/Base）Parameters：
MW HD HA FRB* PSA* cLogP*
426.57 0 6 6 85.0 3.091±0.624
*：Calculated by ACD/Labs software V11.02.
Synthesis & Impurities

Update Date：2016-01-27


1. US4745117A.


1. US4745117A.

Impurity database is being updated！