RHB-101 is a once daily controlled release proprietary formulation of Carvedilol. Carvedilol is marketed under various trade names including GSK’s Coreg®.
RHB-101 was licensed from Egalet a/s (a private Danish company) in November 2009. As carvedilol, RHB-101 is a β-adrenergic blocking agent with α1-blocking activity and is planned to be indicated for the treatment of heart failure, left ventricular dysfunction (following myocardial infarction) and hypertension.
Several clinical PK studies were conducted with RHB-101. RedHill plans to submit a New Drug Application (NDA) in the U.S. and a Marketing Authorization Application (MAA) in Europe during the second half of 2014.