Drugs / TEV-45779
last change Mar 2026 re-read 2 minutes ago

TEV-45779

also known as Omalizumab
Developed for
chronic urticaria
Investigated by
Teva Pharmaceuticals Development, Inc. · Teva Pharmaceuticals USA

Trials 1 · a red edge is where a trial was stopped

20222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 3 NCT04976192 Aug 2021 → Apr 2024 chronic urticaria Teva Pharmaceuticals USA Completed No outcome recorded

Press releases naming this drug 2 releases

DateIssuerRelease
2026-03-30 Teva Branded Pharmaceutical Products R&D, Inc. Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com
2026-03-30 Teva Branded Pharmaceutical Products R&D, Inc. Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab) tevapharm.com

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as TEV-45779 ClinicalTrials.gov intervention name — accepted as the source's own label NCT04976192
Known as Omalizumab “TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe” NCT04976192
Route Subcutaneous “administered sc at doses of 300 mg or 150 mg every 4 weeks” NCT04976192