Revaprazan Hydrochloride

Revaprazan hydrochloride was approved by Korea Food and Drug Administration (KFDA) on September 1, 2005. It was developed and marketed as Revanex® by Yuhan Corporation in KR.

Revaprazan is the first acid pump antagonist with a function similar to that of proton pump inhibitors (PPIs). It has a dual action, active suppression of gastric acid secretion and gastric mucosa protection. It reduces gastric acid secretion which is used for the treatment of gastritis.

Revanex® is available as tablet for oral use, containing 100 or 200 mg of Revaprazan hydrochloride. The recommended dose is 200 mg orally once daily.

General Information

Update Date:2016-03-14

Drug Name:
Revaprazan Hydrochloride
Research Code:
SB-641257A; YH-1885
Trade Name:
Revanex®
MOA:
Proton pump inhibitor/PPI
Indication:
Gastric ulcer; Duodenal ulcer; Gastritis
Status:
Approved
Company:
Yuhan Corporation (Originator) , GlaxoSmithKline
Sales:
ATC Code:
Approved Countries or Area

Update Date:2015-07-29

Approval Date Approval Type Trade Name Indication Dosage Form Strength Company Review Classification
2005-09-01 Marketing approval Revanex Gastric ulcer,Duodenal ulcer,Gastritis Tablet 100 mg/200 mg Yuhan Corporation
Chemical Structure

Update Date:2015-08-27

Molecular Weight 398.90
Formula C22H24ClFN4
CAS No. 199463-33-7 (Revaprazan );
178307-42-1 (Revaprazan Hydrochloride);
Chemical Name N-(4-Fluorophenyl)-4,5-dimethyl- 6-(1-methyl-1,2,3,4-tetrahydroisoquinolin-2-yl)pyrimidin-2-amine hydrochloride
Revaprazan (Free Acid/Base)Parameters:
MW HD HA FRB* PSA* cLogP*
362.44 1 4 2 41.1 5.525±0.615
*:Calculated by ACD/Labs software V11.02.
Synthesis & Impurities

Update Date:2016-01-27



1. US6252076.


1. WO9414795A1.

Impurity database is being updated!