This section highlights FDA-related milestones and regulatory updates for drugs developed by Kezar Life Sciences (KZR).
Over the past two years, Kezar Life Sciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
zetomipzomib and Zetomipzomib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
Zetomipzomib FDA Regulatory Timeline and Events
Zetomipzomib is a drug developed by Kezar Life Sciences for the following indication: In Patients with Autoimmune Hepatitis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- zetomipzomib
- Announced Date:
- July 15, 2025
- Indication:
- In Patients with Autoimmune Hepatitis
Announcement
Kezar Life Sciences, Inc. announced that the Division of Hepatology and Nutrition of the U.S. Food and Drug Administration (FDA) has lifted the partial clinical hold on the completed PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH).
AI Summary
Kezar Life Sciences recently announced a significant regulatory update for its PORTOLA Phase 2a clinical trial. The FDA’s Division of Hepatology and Nutrition has lifted a partial clinical hold on the completed trial that evaluated zetomipzomib in patients with autoimmune hepatitis (AIH). Zetomipzomib is a first-in-class selective immunoproteasome inhibitor, offering a new approach to treat AIH by targeting the underlying inflammation without broadly suppressing the immune system.
The lifting of the hold comes after the FDA reviewed a comprehensive safety assessment of the zetomipzomib program. Kezar Life Sciences is encouraged by this decision and believes the treatment could positively transform the lives of patients suffering from AIH. The company now looks forward to collaborating with the FDA to design the next clinical trial and continue advancing this promising therapy.
Read Announcement- Drug:
- zetomipzomib
- Announced Date:
- March 25, 2025
- Indication:
- In Patients with Autoimmune Hepatitis
Announcement
Kezar Life Sciences, Inc today reported positive topline results from the PORTOLA Phase 2a clinical trial evaluating zetomipzomib, a novel, first-in-class selective immunoproteasome inhibitor, in patients with autoimmune hepatitis (AIH) and reported fourth quarter and year end 2024 financial results.
AI Summary
Kezar Life Sciences, Inc. announced positive topline results from its PORTOLA Phase 2a trial, which tested zetomipzomib—a new, first-in-class selective immunoproteasome inhibitor—in patients with autoimmune hepatitis (AIH). The trial, aimed at treating difficult-to-manage patients who are steroid-dependent, showed that a significant number of patients achieved complete biochemical responses with a reduction in steroid use to 5 mg/day or less. The positive outcomes include a median response duration of 27.6 weeks and a good safety profile with few disease flares. Along with the clinical news, the company released its fourth quarter and year-end 2024 financial results, reporting cash and marketable securities totaling $132 million and detailing reduced expenses compared to the previous year. These encouraging findings are expected to support further discussions with the FDA to advance the development of zetomipzomib in AIH.
Read Announcement- Drug:
- zetomipzomib
- Announced Date:
- March 24, 2025
- Estimated Event Date Range:
- March 25, 2025 - March 25, 2025
- Target Action Date:
- March 25, 2025
- Indication:
- In Patients with Autoimmune Hepatitis
Announcement
Kezar Life Sciences, Inc announced that it will present topline results from the PORTOLA Phase 2a trial evaluating zetomipzomib for the treatment of patients with autoimmune hepatitis (AIH) on Tuesday, March 25, 2025, at 8:00 a.m. ET.
AI Summary
Kezar Life Sciences, Inc. announced it will present topline results from its PORTOLA Phase 2a clinical trial, which evaluates the efficacy and safety of zetomipzomib for treating autoimmune hepatitis (AIH). The trial is placebo-controlled, randomized, and double-blind. This study focuses on patients with AIH who have not sufficiently responded to standard care or have relapsed. The presentation is scheduled for Tuesday, March 25, 2025, at 8:00 a.m. ET, and will highlight key findings, including whether patients achieved a complete biochemical response by Week 24. Experts in the field, including Dr. Craig Lammert and Dr. Gideon Hirschfield, will share their insights during the event. A live question and answer session will follow the formal presentation, allowing interested parties to engage directly with the researchers.
Read Announcement
Zetomipzomib (LN) FDA Regulatory Events
Zetomipzomib (LN) is a drug developed by Kezar Life Sciences for the following indication: Lupus Nephritis (LN).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Zetomipzomib (LN)
- Announced Date:
- October 4, 2024
- Indication:
- Lupus Nephritis (LN)
Announcement
Kezar Life Sciences, Inc announced that it was informed via teleconference with the U.S. Food and Drug Administration (FDA) that the zetomipzomib Investigational New Drug (IND) application for the treatment of lupus nephritis (LN) has been placed on clinical hold.
AI Summary
Kezar Life Sciences announced that during a recent teleconference with the U.S. Food and Drug Administration (FDA), the agency placed the Investigational New Drug (IND) application for their investigational drug, zetomipzomib, on clinical hold for the treatment of lupus nephritis (LN). The FDA communicated that an official clinical hold letter will be provided to Kezar within the next 30 days.
This decision underscores the agency’s caution in advancing the development program. Kezar Life Sciences emphasized that patient safety is their top priority as they work to understand and address the issues raised. The company is fully committed to investigating the underlying concerns to ensure that any future steps in the program meet the necessary safety standards while they await further guidance from the FDA.
Read Announcement- Drug:
- Zetomipzomib (LN)
- Announced Date:
- September 30, 2024
- Indication:
- Lupus Nephritis (LN)
Announcement
Kezar Life Sciences, Inc announced the voluntary cessation in enrollment of new patients and dosing of ongoing patients in the Phase 2b PALIZADE clinical trial, pending further evaluation.
AI Summary
Kezar Life Sciences, Inc. announced it is pausing enrollment of new patients and dosing of current patients in its Phase 2b PALIZADE clinical trial. The trial is testing the safety and effectiveness of different doses of the drug zetomipzomib in patients with active lupus nephritis. This decision follows a recent review by an Independent Data Monitoring Committee, which looked at safety data and noted four fatal serious adverse events in patients from the Philippines and Argentina. The review found that three of these cases shared similar symptoms and occurred soon after dosing. The pause will allow the company time to further evaluate the adverse events and consider risk mitigation strategies. Kezar has informed study investigators and notified regulatory authorities, including the FDA, as it works to ensure patient safety and determine the next steps in the trial.
Read Announcement