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.
|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|
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：|
|*：Calculated by ACD/Labs software V11.02.|