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Voclosporin - Aurinia Pharmaceuticals

Drug Profile

Voclosporin - Aurinia Pharmaceuticals

Alternative Names: trans-ISA 247; trans-R 1524; ISA(TX)247; ISA-247; ISAtx 247; ISATx247; LUPKYNIS; Orelvo; R-1524; Voclera

Latest Information Update: 11 Aug 2022

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At a glance

  • Originator Isotechnika
  • Developer Atrium Medical Corporation; Aurinia Pharmaceuticals; Isotechnika; Leiden University Medical Center; Otsuka Pharmaceutical; Paladin Labs
  • Class Anti-inflammatories; Antipsoriatics; Antirheumatics; Antivirals; Ciclosporins; Eye disorder therapies; Immunotherapies; Skin disorder therapies; Small molecules; Urologics; Vascular disorder therapies
  • Mechanism of Action Calcineurin inhibitors; Immunosuppressants; Virus replication inhibitors
  • Orphan Drug Status

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

    Yes - Lupus nephritis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Lupus nephritis
  • Phase II COVID 2019 infections; Focal segmental glomerulosclerosis
  • No development reported Nephrotic syndrome; Renal transplant rejection
  • Discontinued Coronary artery restenosis; Plaque psoriasis; Rheumatoid arthritis

Most Recent Events

  • 04 Aug 2022 Aurinia Pharmaceuticals expects decision of European Commission (EC) regarding MAA for Lupus nephritis in the third quarter of 2022
  • 26 Jul 2022 Aurinia Pharmaceuticals received notice regarding the U.S. Patent Office (USPTO) Patent Trial and Appeal Board (PTAB) decision to institute trial on the Inter Partes review (IPR) filed by Sun Pharmaceuticals, directed at U.S. Patent No. 10,286,036.
  • 25 Jul 2022 CHMP of the EMA recommends approval of voclosporin for Lupus nephritis in the European Union
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