Posted by Michael Wonder on 10 Feb 2025
Tempest granted fast track designation from the US FDA for amezalpat to treat patients with hepatocellular carcinoma
10 January 2025 - Tempest Therapeutics today announced that the US FDA has granted fast track designation to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma.
The company announced in January that the US FDA granted amezalpat with orphan drug designation following positive data across multiple key study efficacy and safety endpoints in a global randomised Phase 1b/2 clinical study evaluating amezalpat plus standard of care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.
