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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: 11 Mar 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 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

  • 02 Mar 2025 Efficacy and adverse events data from the phase III OUtMATCH trial in Food hypersensitivity and Peanut hypersensitivity released by Genentech
  • 23 Feb 2024 Efficacy and adverse events data from a phase III OUTMATCH trial in Food hypersensitivity and Peanut hypersensitivity presented at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI-2024) Annual Meeting (AAAAI-2024)
  • 16 Feb 2024 Registered for Food hypersensitivity (In adolescents, In children, Adjuvant therapy, In adults) in USA (SC) (NCT03881696)

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