GDC 0853

Drug Profile

GDC 0853

Alternative Names: Bruton’s tyrosine kinase inhibitor - Genentech; GDC-0853; RG 7845; RO 7010939

Latest Information Update: 17 Feb 2017

Price : $50

At a glance

  • Originator Genentech
  • Class Antineoplastics
  • 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.

  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Rheumatoid arthritis
  • Phase I Autoimmune disorders
  • Discontinued Chronic lymphocytic leukaemia; Non-Hodgkin's lymphoma

Most Recent Events

  • 01 Dec 2016 Genentech initiates an extension phase II trial for Rheumatoid arthritis (Adjunctive treatment, Treatment-experienced) in USA (PO, Tablet) (NCT02983227)
  • 11 Nov 2016 Pooled safety and pharmacokinetic results from the phase I trials were presented at the 80th American College of Rheumatology and the 51st Annual Meeting of the Association of Rheumatology and Health Professionals (ACR/ARHP - 2016)
  • 14 Sep 2016 Genentech plans a phase II trial for Systemic lupus erythematosus in USA, Argentina, Brazil, Bulgaria, Chile, Colombia, France, South Korea, Mexico, Spain, Thailand and United Kingdom (NCT02908100)
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