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Orelabrutinib - InnoCare Pharma

Drug Profile

Orelabrutinib - InnoCare Pharma

Alternative Names: BIIB-135; ICP 022; INNOBRUKA; YINUOKAI

Latest Information Update: 17 Apr 2024

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At a glance

  • Originator InnoCare Pharma
  • Class Amides; Anti-inflammatories; Antineoplastics; Antirheumatics; Eye disorder therapies; Phenyl ethers; Piperidines; Pyridines; Small molecules
  • Mechanism of Action Agammaglobulinaemia tyrosine kinase inhibitors
  • Orphan Drug Status

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

    Yes - Mantle-cell lymphoma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic lymphocytic leukaemia; Mantle-cell lymphoma; Marginal zone B-cell lymphoma
  • Preregistration Waldenstrom's macroglobulinaemia
  • Phase III Diffuse large B cell lymphoma; Idiopathic thrombocytopenic purpura
  • Phase II Lymphoma; Multiple sclerosis; Neuromyelitis optica; Non-Hodgkin's lymphoma; Systemic lupus erythematosus
  • Phase I/II B-cell lymphoma; Follicular lymphoma
  • Phase I Liver disorders
  • Discontinued Rheumatoid arthritis

Most Recent Events

  • 12 Apr 2024 InnoCare Pharma plans a phase III trial for Mantle cell lymphoma (Combination therapy, Treatment-naïve, First line therapy, Late stage disease) (PO), in May 2024 (NCT06363994)
  • 28 Mar 2024 InnoCare Pharma announces intention to submit New Drug Application (NDA) for Chronic lymphocytic leukaemia (First-line therapy) in the third quarter of 2024
  • 28 Mar 2024 InnoCare Pharma plans to submit NDA in Mantle-cell lymphoma (Second-line therapy or greater) in USA in the third quarter of 2024
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