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Omalizumab - Genentech/Novartis

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Drug Profile

Omalizumab - Genentech/Novartis

Alternative Names: Anti-IgE monoclonal antibody E25; E 25; IgE 025; Monoclonal antibody E25; Olizumab; Recombinant human monoclonal antibody E25; RG-3648; rhuMAb 25; rhuMAb E25; Xolair

Latest Information Update: 23 Jul 2025

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At a glance

  • Originator Genentech
  • Developer Dana-Farber Cancer Institute; Genentech; John Hopkins University; National Institute of Allergy and Infectious Diseases; Novartis
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Monoclonal antibodies; Skin disorder therapies
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Allergic asthma; Chronic urticaria; Nasal polyps
  • Registered Food hypersensitivity; Peanut hypersensitivity; Seasonal allergic rhinitis
  • Phase II/III Mastocytosis
  • Phase II Asthma; Nephritis
  • No development reported Hypersensitivity

Most Recent Events

  • 23 Jul 2025 3903353-NO update
  • 02 Mar 2025 Efficacy and adverse events data from the phase III OUtMATCH trial in Food hypersensitivity and Peanut hypersensitivity released by Genentech
  • 28 Feb 2025 Efficacy data from a phase III OUtMATCH trail in Food allergy presented at the 2025 Annual Meeting of the American Academy of Allergy, Asthma and Immunology/World Allergy Organization Joint Congress (AAAAI-2025)

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