Officials with Regulus Therapeutics Inc. have announced they received verbal notice from the 
US Food and Drug Administration (FDA) that the Investigational New Drug (IND) for RG-101 for the treatment of chronic hepatitis C virus (HCV) infection has been placed on clinical hold after a second report of jaundice. 

The serious adverse event of jaundice occurred in a HCV patient with end-stage renal disease on dialysis enrolled in its on-going phase 1 US study 117 days after receiving a single dose of RG-101.

Officials with Regulus said in a prepared statement they anticipate a formal clinical hold letter from the FDA within 30 days and plans to work diligently with the agency to seek the release of the clinical hold.

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Timelines for Regulus’ three on-going studies of RG-101 are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits.