Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

A Multinational, Multicenter, Randomized, Double Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizumab (XOLAIR) in Patients With Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Next Previous
Trial Profile

A Multinational, Multicenter, Randomized, Double Blind Study to Evaluate the Efficacy, Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of TEV-45779 Compared to Omalizumab (XOLAIR) in Patients With Chronic Idiopathic Urticaria/Chronic Spontaneous Urticaria Who Remain Symptomatic Despite Antihistamine (H1) Treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Apr 2026

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Omalizumab (Primary)
  • Indications Chronic urticaria
  • Focus Registrational; Therapeutic Use
  • Sponsors Teva Pharmaceuticals USA

Most Recent Events

  • 30 Mar 2026 According to Teva Pharmaceutical Industries media release, company's applications have been accepted by both the U.S. FDA and the European Medicines Agency (EMA). The regulatory submissions for the biosimilar candidate to Xolair (omalizumab) consist of a Biologics License Application (BLA) to the U.S. FDA and a Marketing Authorization Application (MAA) in the European Union (EU) to the EMA.
  • 18 Apr 2024 Status changed from active, no longer recruiting to completed.
  • 21 Mar 2024 Planned End Date changed from 1 Jun 2024 to 5 Apr 2024.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top