Ozmosi | Vixarelimab Drug Profile
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Vixarelimab

Alternative Names: vixarelimab, KPL-716, KPL716, KPL 716, RG6536, RG 6536, RG-6536
Clinical Status: Active
Latest Update: 2026-01-08
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Vixarelimab

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