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FDA grants fast track designation to FXR agonist for NASH

The FDA granted fast track designation to Terns Pharmaceuticals for TERN-101, an investigational farnesoid X receptor being evaluated for nonalcoholic steatohepatitis, according to a press release.

“Receiving fast track designation for TERN-101 is an important step in bringing this promising treatment to patients as soon as possible, and we look forward to working with the agency as we advance TERN-101 through clinical development,” Erin Quirk, MD, chief medical officer of Terns, said in the release. “We are pleased that the U.S. FDA recognizes the potential for TERN-101 to address the unmet treatment need for patients with NASH, who currently have no therapeutic options.”

Data from phase 1 studies of TERN-101 demonstrated clinical pharmacokinetic properties consistent with once-daily dosing. Additionally, TERN-101 has shown effects on liver steatosis, inflammation, ballooning and fibrosis.

TERN-101 along with TERN-201, a semicarbazide-sensitive amine oxidase inhibitor, are both in development for the treatment of NASH and were initially discovered and developed by Eli Lilly and Company.

Reference: www.ternspharma.com