Kezar Life Sciences Receives FDA Clearance to Proceed with Zetomipzomib Clinical Trial in Autoimmune Hepatitis

Kezar Life Sciences announced that the FDA has lifted a partial clinical hold on its PORTOLA Phase 2a trial for zetomipzomib in patients with autoimmune hepatitis. The company plans to engage with the FDA to align on the design of the next clinical trial. Zetomipzomib, a selective immunoproteasome inhibitor, has shown a favorable safety and tolerability profile in preclinical and clinical trials.

Kezar Life Sciences, Inc. (Nasdaq: KZR), a clinical-stage biotechnology company, has received a significant regulatory milestone. The Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) has lifted a partial clinical hold on the completed PORTOLA Phase 2a trial evaluating zetomipzomib, a selective immunoproteasome inhibitor, for patients with autoimmune hepatitis [2].

The company plans to engage with the FDA to align on the design of the next clinical trial. Zetomipzomib has shown a favorable safety and tolerability profile in preclinical and clinical trials, with positive topline results from the PORTOLA Phase 2a trial announced on March 25, 2025 [1].

This development is expected to accelerate the drug's development process and bring it one step closer to potential approval by the FDA. Kezar Life Sciences is committed to advancing novel small molecule therapeutics to treat unmet needs in immune-mediated diseases.

References:
[1] https://www.marketbeat.com/stocks/NASDAQ/KZR/fda-events/
[2] https://www.stocktitan.net/news/KZR/kezar-life-sciences-announces-fda-has-lifted-partial-clinical-hold-48dl9jql9sjo.html