trending Market Intelligence /marketintelligence/en/news-insights/trending/E7uqo36lgmpSg5LDpfYCjA2 content esgSubNav
In This List

US FDA keeps clinical hold on Regulus hepatitis C drug

Blog

Essential IR Insights Newsletter Fall - 2023

Case Study

A Corporation Clearly Pinpoints Activist Investor Activity

Blog

Insight Weekly: Bank mergers of equals return; energy tops S&P 500; green bond sales to rise

Blog

Insight Weekly: US companies boost liquidity; auto insurers hike rates; office sector risk rises


US FDA keeps clinical hold on Regulus hepatitis C drug

The U.S. FDA kept its clinical hold on Regulus Therapeutics Inc.'s clinical development program for RG-101 for the treatment of hepatitis C virus.

The drug was placed on clinical hold in June 2016 after Regulus' submission of a second serious adverse event of jaundice.

Regulus submitted a complete response to the FDA's initial request for information in 2016, which included identification of a potential mechanism of hyperbilirubinemia. It also submitted a proposal to mitigate this risk.

Subsequently, the FDA requested the final safety and efficacy data from ongoing clinical and pre-clinical studies for the drug before reconsidering the clinical hold. The FDA also requested additional expert review of liver safety data due to the proposed mechanism of hyperbilirubinemia.