FDA Partial Hold on Sun JAK Inhibitor Trial

FDA has placed a partial clinical hold on Sun Pharma’s Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia areata, after reporting a serious adverse event (pulmonary embolism) that occurred in a patient taking a 12 mg BID dose in a long-term open label extension study.

The partial hold, due to the potential for thrombotic events, requires subjects currently on the 12 mg BID dose to discontinue that dose, Sun says. “There have been no thrombotic events reported to date for the 8 mg BID dose and U.S. FDA has not placed the 8 mg BID dose on hold,” it adds. “We are taking immediate steps to transition the patients in the OLE studies to the 8 mg BID dose arm in the ongoing studies.”

JAK inhibitors have had a history of being associated with blood clots. In 2021, FDA issued a safety warning about blood clots and other risks associated with some drugs in the class.