Sun Pharma’s Deuruxolitinib IND Placed on Partial Clinical Hold

The FDA has placed a partial clinical hold on Sun Pharma’s IND application for Deuruxolitinib (CTP-543), which was being studied in patients with alopecia areata, an autoimmune disease that includes hair loss.

The agency decision follows the report of a serious adverse event of pulmonary embolism occurring at the 12 mg twice a day dose in one of the long-term open label extension studies.

Despite the serious adverse event, the company said that no thromboembolic events occurred in phase 2 and phase 3 clinical trials and that it will work with the FDA to address the agency’s concerns, which will be expressed in a formal letter, to be received by Sun Pharma within the next 30 days.

Related Topics