Trial Profile

A registrational clinical trial of zetomipzomib in patients with relapsed and refractory autoimmune hepatitis (AIH)

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 08 Feb 2026

Price :

$35 ^*

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

09 Jan 2026 According to a Kezar Life Sciences media release, company submitted additional safety data and an updated risk-mitigation plan aimed at modifying the FDA's previous requirement for 48-hour in-unit patient monitoring in future AIH studies.
09 Jan 2026 According to a Kezar Life Sciences media release, the U.S. Food and Drug Administration (FDA) Division of Hepatology and Nutrition has granted a Type C meeting in the first quarter to discuss the clinical development of zetomipzomib for autoimmune hepatitis (AIH). The Type C meeting will include a review of a proposed global, randomized Phase 2b clinical study of zetomipzomib in patients with relapsed and refractory AIH.
15 Dec 2025 New trial record

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial (opens in a new window)

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com