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# Tempest Gets Fast Track for Amezalpat
- URL: https://www.fdaweb.com/tempest-gets-fast-track-for-amezalpat/
- Published: 2025-02-10T12:00:00.000Z
- Updated: 2026-09-14T14:52:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158634

FDA has granted Tempest Therapeutics a fast track designation for amezalpat (TPST-1120), a small molecule, selective PPAR⍺ antagonist for treating patients with hepatocellular carcinoma (HCC). The company says the designation is based on positive data across multiple key study endpoints in a global randomized Phase 1b/2 study evaluating amezalpat plus standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in HCC patients. For example, there was a six-month improvement in median overall survival for patients receiving the amezalpat combination therapy, it says. “In addition, a survival benefit from the addition of amezalpat was preserved in key sub-populations including PD-L1 negative disease, which is consistent with amezalpat’s proposed mechanism of action to target both the tumor cells directly and the patient’s immune system.”