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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
  • 01 Jul 2025 National Institute of Allergy and Infectious Diseases in collaboration with Genentech and Novartis Pharmaceuticals completes the phase III OUtMATCH trial in Food hypersensitivity and Peanut hypersensitivity (Monotherapy, Adjuvant therapy, In children, In adults, In adolescents) in USA (SC) (NCT03881696)
  • 02 Mar 2025 Efficacy and adverse events data from the phase III OUtMATCH trial in Food hypersensitivity and Peanut hypersensitivity released by Genentech

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