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Inebilizumab - Horizon Therapeutics plc

Drug Profile

Inebilizumab - Horizon Therapeutics plc

Alternative Names: 16C4-aFuc; A-fucosylated anti-CD19 antibody; Anti-CD19 MAb-Horizon Therapeutics plc; Inebilizumab-cdon; MEDI 551; MT-0551; UPLIZNA; VIB-0551

Latest Information Update: 14 Feb 2024

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At a glance

  • Originator Duke University
  • Developer Horizon Therapeutics plc; Jiangsu Hansoh Pharmaceutical; MedImmune; Mitsubishi Tanabe Pharma Corporation
  • Class Antineoplastics; Eye disorder therapies; Immunotherapies; Monoclonal antibodies; Skin disorder therapies
  • Mechanism of Action Antibody-dependent cell cytotoxicity; T lymphocyte stimulants
  • Orphan Drug Status

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

    Yes - Neuromyelitis optica; Scleroderma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Neuromyelitis optica
  • Phase III Autoimmune disorders; Myasthenia gravis; Systemic scleroderma
  • No development reported Renal transplant rejection
  • Discontinued B-cell lymphoma; Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Multiple myeloma; Multiple sclerosis

Most Recent Events

  • 06 Feb 2024 Horizon Therapeutics completes enrolment in its phase III trial in Autoimmune disorders in Germany, Hungary, Japan, Poland, Sweden, Ukraine, the US, Argentina, Australia, Canada, China, France, Hong Kong, India, Ireland, Israel, Italy, Mexico, Netherlands, Spain, Turkey and the UK (NCT04540497)
  • 31 Jan 2024 Horizon Therapeutics completes enrolment in its phase III clinical trials in Myasthenia gravis in USA, Argentina, Brazil, Belarus, Canada, China, Denmark, France, Germany, Italy, Poland, India, Russia, Spain, South Korea, Taiwan, Turkey, Ukraine (IV) (NCT04524273)
  • 15 Dec 2023 Registered for Neuromyelitis optica in Canada (IV)
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