Omalizumab - Genentech/Novartis

Drug Profile

Omalizumab - Genentech/Novartis

Alternative Names: Anti-IgE monoclonal antibody E25; E 25; Humanised anti-IgE MAb; IgE 025; Monoclonal antibody E25; Olizumab; Recombinant human monoclonal antibody E25; rhuMAb 25; rhuMAb E25; Xolair

Latest Information Update: 06 Nov 2017

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At a glance

  • Originator Genentech
  • Developer Genentech; John Hopkins University; Novartis
  • Class Antiallergics; Antiasthmatics; Monoclonal antibodies
  • Mechanism of Action IgE receptor antagonists; Immunosuppressants
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Allergic asthma; Urticaria
  • Phase III Nasal polyps
  • Phase II/III Mastocytosis
  • Phase II Asthma; Nephritis
  • No development reported Peanut hypersensitivity

Most Recent Events

  • 06 Oct 2017 Phase-III clinical trials in Nasal polyps in USA (SC) (NCT03280537) (NCT03280550)
  • 19 Sep 2017 Roche plans a phase III trial for Chronic sinusitis in USA, Belgium, Finland, France, Hungary, Mexico, Poland, Russia, Spain and Ukraine (NCT03280537)
  • 16 Sep 2017 Efficacy and adverse events data from the phase IIIb OPTIMA trial in Urticaria released by Novartis
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