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Zetomipzomib - Kezar Life Sciences

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Drug Profile

Zetomipzomib - Kezar Life Sciences

Alternative Names: KZR-616

Latest Information Update: 28 Aug 2025

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At a glance

  • Originator Onyx Pharmaceuticals
  • Developer Everest Medicines; Kezar Life Sciences
  • Class Anti-inflammatories; Antianaemics; Antirheumatics; Cyclopentanes; Hepatoprotectants; Morpholines; Small molecules; Urologics
  • Mechanism of Action Proteasome inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Polymyositis; Dermatomyositis
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Autoimmune hepatitis; Dermatomyositis; Polymyositis; Systemic lupus erythematosus
  • Preclinical Haemophagocytic lymphohistiocytosis
  • Suspended Lupus nephritis
  • No development reported Autoimmune disorders

Most Recent Events

  • 14 Aug 2025 Kezar submits a complete response to the FDA Division of Rheumatology and Transplant Medicine with a request to remove the clinical hold on Zetomipzomib in lupus nephritis
  • 13 Aug 2025 Kezar submitted a Type C meeting request to the FDA to plan meet to discuss the autoimmune hepatitis (AIH) development in fourth quarter of 2025
  • 15 Jul 2025 Kezar plans to respond to the US FDA Division of Rheumatology and Transplant Medicine with a request to lift the clinical hold on zetomipzomib in Lupus nephritis (prior to July 2025)

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