Mozavaptan Hydrochloride

Mozavaptan hydrochloride was approved by Pharmaceuticals and Medical Devices Agency of Japan (PMDA) on July 26, 2006. It was developed and marketed as Physuline® by Otsuka in Japan.

Mozavaptan hydrochloride is a vasopressin receptor antagonist. It is indicated for the treatment of hyponatremia due to excessive fluid retention when restriction of fluid intake is ineffective.

Physuline® is available as film-coated tablet for oral use, containing 30 mg of Mozavaptan hydrochloride. The recommended dose is one tablet (30 mg) once daily after a meal.

General Information

Update Date:2016-03-23

Drug Name:
Mozavaptan Hydrochloride
Research Code:
OPC-31260; OPC-129
Trade Name:
Physuline®
MOA:
Vasopressin receptor antagonist
Indication:
Hyponatremia
Status:
Approved
Company:
Otsuka (Originator)
Sales:
ATC Code:
C03XA
Approved Countries or Area

Update Date:2016-03-09

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2006-07-26 Marketing approval Physuline Hyponatremia Tablet, Film coated 30 mg Mozavaptan hydrochloride Otsuka
Chemical Structure

Update Date:2015-08-27

Molecular Weight 464
Formula C27H29N3O2 • HCl
CAS No. 137975-06-5 (Mozavaptan );
138470-70-9 (Mozavaptan HCl);
Chemical Name N-(4-{[(5RS)-5-(dimethylamino)-2,3,4,5-tetrahydro-1H-benzo[b]azepin-1-yl]carbonyl}phenyl)-2-methylbenzamide monohydrochloride
Mozavaptan (Free Acid/Base)Parameters:
MW HD HA FRB* PSA* cLogP*
427.54 1 5 4 52.7 3.831±0.509
*:Calculated by ACD/Labs software V11.02.
Synthesis & Impurities

Update Date:2015-10-21


1. WO9105549A1 / US5258510A.


1. CN103833636A.

Impurity database is being updated!