Product Description
Zetomipzomib (KZR-616) is a first-in-class, selective immunoproteasome inhibitor for a range of autoimmune diseases. Immunoproteasomes play an important role in regulating the normal function of the immune system and when inhibited, multiple pathways involved in inflammatory cytokine production and immune effector cell activity – including macrophages, B cells and T cells – are also inhibited. Since the pathways regulated by immunoproteasomes are involved in the pathogenesis of many autoimmune diseases, zetomipzomib offers a "pipeline in a drug" approach, with the potential to be a treatment option for a broad range of autoimmune conditions. (Sourced from: https://www.kezarlifesciences.com/pipeline/zetomipzomib)
Mechanisms of Action: Proteasome Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Subcutaneous, Intravenous
FDA Designation: Orphan Drug - Dermatomyositis|Myositis|Polymyositis *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Clinical Network Services
Company Location: Asia Pacific
Company Founding Year: 1998
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Croatia, Czech Republic, France, Germany, Greece, Italy, Portugal, Spain, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Kezar Life Sciences presented P2 Hepatitis, Autoimmune results on 2025-03-25 for Zetomipzomib
- Clinical Outcomes Reported - Kezar Life Sciences presented P2 Hepatitis, Autoimmune results on 2025-02-27 for Zetomipzomib
- Clinical Outcomes Reported - Kezar Life Sciences announced they will present P2 Hepatitis, Autoimmune results in 1H25 for Zetomipzomib
Highest Development Phases
Phase 2: Dermatomyositis|Hepatitis A|Hepatitis, Autoimmune|Lupus Nephritis|Polymyositis
Phase 1: Arthritis, Rheumatoid|Lupus Erythematosus, Systemic
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
ACTRN12618002060224 |
ACTRN12618002060224 | P1 |
Not yet recruiting |
Arthritis, Rheumatoid|Lupus Erythematosus, Systemic |
2019-04-18 |
2026-02-15 |
Treatments |
|
NCT05569759 |
PORTOLA | P2 |
Completed |
Hepatitis, Autoimmune|Hepatitis A |
2025-04-30 |
50% |
2025-05-31 |
|
2022-502227-22-00 |
KZR-616-202 | P2 |
Completed |
Lupus Nephritis |
2024-10-17 |
2025-05-02 |
Treatments |
|
NCT04628936 |
KZR-616-003E | P2 |
Completed |
Dermatomyositis|Polymyositis |
2023-03-10 |
59% |
2024-06-06 |
Primary Endpoints|Treatments |
2020-004382-39 |
2020-004382-39 | P2 |
Active, not recruiting |
Polymyositis|Dermatomyositis |
2023-04-02 |