Product Description
Vixarelimab is a fully-human monoclonal antibody that targets oncostatin M receptor beta (OSMRbeta). The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation to vixarelimab for the treatment of pruritus associated with prurigo nodularis in 2020. (Sourced from: https://investors.kiniksa.com/news-releases/news-release-details/kiniksa-commences-dosing-vixarelimab-phase-2b-clinical-trial)
Mechanisms of Action: OSRMb Antagonist
Novel Mechanism: Yes
Modality: Antibody
Route of Administration: Subcutaneous
FDA Designation: Breakthrough Therapy - Prurigo|Pruritus *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location:
Company CEO: Severin Schwan
Additional Commercial Interests: Kiniksa Pharmaceuticals
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, Chile, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Mexico, New Zealand, Poland, South Africa, South Korea, Spain, Taiwan, United States
Active Clinical Trial Count: 5
Recent & Upcoming Milestones
Highest Development Phases
Phase 2: Colitis, Ulcerative|Idiopathic Pulmonary Fibrosis|Lung Diseases, Interstitial|Prurigo|Pruritus|Scleroderma, General
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2022-502828-42-00 |
GB44496 | P2 |
Recruiting |
Idiopathic Pulmonary Fibrosis|Scleroderma, General|Lung Diseases, Interstitial |
2026-04-30 |
12% |
2025-05-02 |
Treatments |
NCT06693908 |
GA45735 | P2 |
Recruiting |
Colitis, Ulcerative |
2026-04-03 |
12% |
2025-03-18 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT05785624 |
GB44496 | P2 |
Active, not recruiting |
Scleroderma, General|Idiopathic Pulmonary Fibrosis |
2026-01-09 |
12% |
2026-01-09 |
|
2020-004198-38 |
2020-004198-38 | P2 |
Completed |
Pruritus|Prurigo |
2023-08-24 |
2025-06-30 |
Treatments |
|
2023-506655-19-00 |
GA44839 | P2 |
Recruiting |
Colitis, Ulcerative |
2027-07-15 |
12% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
05/09/2024 |
PubMed |
Chronic Prurigo. |
|
04/01/2024 |
PubMed |
A systematic review of interleukin-31 inhibitors in the treatment of prurigo nodularis. |
|
01/01/2024 |
PubMed |
Chronic Prurigo Including Prurigo Nodularis: New Insights and Treatments. |
|
01/09/2023 |
News Article |
TFF Pharmaceuticals Announces the Appointment of Zamaneh Mikhak, M.D. as Chief Medical Officer |
|
09/12/2022 |
News Article |
Kiniksa Pharmaceuticals Announces Closing of Global License Agreement with Genentech for Vixarelimab |
|
08/03/2022 |
News Article |
Kiniksa Pharmaceuticals Announces Global License Agreement with Genentech for Vixarelimab |
|
08/02/2022 |
News Article |
Kiniksa Pharmaceuticals to Report Second Quarter 2022 Financial Results on August 3, 2022 |