Reduces allergic reactions (Type I), including anaphylaxis. Sold as Xolair. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Omalizumab (sold as Xolair), first approved Jun 20, 2003, with 8 new uses approved and 0 published complete response letters.
| Oral Food Challenge After One to Two Doses of Omalizumab Treatment for Food AllergyFood Allergy · Johns Hopkins University | Phase 4 | Recruiting | Sep 29, 2026 |
| Characteristics and Management of Patients With Severe Chronic Spontaneous and/or Inducible Urticaria Refractory to Optimized Omalizumab Treatment: A French Multicenter Observational Study.Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) · Centre Hospitalier Universitaire de Besancon | — | Recruiting | Sep 22, 2026 |
| T2AIR: Real-World Efficacy and Safety of Biologics Targeting Type 2 Inflammation in Asthma and COPDAsthma, COPD (Chronic Obstructive Pulmonary Disease) · Shanghai Pulmonary Hospital, Shanghai, China | — | Recruiting | Sep 16, 2026 |
| Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 WeeksChronic Spontaneous Urticaria · Novartis Pharmaceuticals | Phase 3 | Recruiting | Sep 11, 2026 |
| Expression of TSLP Isoforms in AsthmaAsthma Atopic, Asthma Severe Persistent Uncontrolled · Medical University of Warsaw | — | Recruiting | Aug 26, 2026 |
| Effects of Diet and Oxidative Stress on Disease Severity and Response to Omalizumab in Chronic Spontaneous UrticariaChronic Spontaneous Urticaria (CSU) · Istanbul Training and Research Hospital | — | Enrolling by invitation | Feb 24, 2026 |
| ROLL'YN-OMA: an Observational Study in Patients Treated by Omlyclo®, an Omalizumab BiosimilarChronic Spontaneous Urticaria (CSU), Allergic Asthma · Celltrion HealthCare France | — | Recruiting | Feb 23, 2026 |
| Deep Phenotyping of CIndUSkin Diseases, Angio-Oedema and/or Urticaria · Centre for Human Drug Research, Netherlands | — | Recruiting | Jan 22, 2026 |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
