Drug Type Monoclonal antibody |
Synonyms Anti-IgE monoclonal antibody E25, Monoclonal antibody E25, Olizumab + [18] |
Target |
Action inhibitors |
Mechanism IgE inhibitors(Immunoglobulin E inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date Australia (13 Jun 2002), |
RegulationBreakthrough Therapy (United States), Priority Review (United States) |


| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D05251 | Omalizumab |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Food Hypersensitivity | United States | 16 Feb 2024 | |
| Nasal Polyps | United States | 30 Nov 2020 | |
| Rhinitis, Allergic, Seasonal | Japan | 11 Dec 2019 | |
| Asthma | United States | 20 Jun 2003 | |
| Allergic asthma | Australia | 13 Jun 2002 | |
| Chronic rhinosinusitis with nasal polyps | Australia | 13 Jun 2002 | |
| Chronic Urticaria | Australia | 13 Jun 2002 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Lung Diseases, Obstructive | NDA/BLA | Canada | 01 Apr 2026 | |
| Chronic sinusitis | NDA/BLA | China | 19 Jul 2022 | |
| Chronic sinusitis | NDA/BLA | China | 19 Jul 2022 | |
| Peanut Hypersensitivity | Phase 3 | United States | 22 Jul 2019 | |
| Peanut Hypersensitivity | Phase 3 | United States | 22 Jul 2019 | |
| Bronchitis | Phase 3 | Canada | 01 Mar 2014 | |
| Angioedema | Phase 3 | Germany | 23 Jan 2013 | |
| Severe persistent asthma | Phase 3 | France | 01 Sep 2009 | |
| Seasonal allergic conjunctivitis | Phase 3 | Germany | 01 Feb 2006 | |
| Persistent asthma | Phase 3 | - | 01 Jul 2000 |
Phase 2 | 130 | (Cohort A: Omalizumab Followed by Placebo for Dupilumab With Multi-Food Oral Immunotherapy) | tkbkfzytcf = zotktuhrdg lvjecltswk (wjnfxiivqf, iyndtzkpzr - xrcfwpnqrf) View more | - | 29 May 2026 | ||
(Cohort B: Omalizumab Followed by Dupilumab With Multi-Food Oral Immunotherapy) | tkbkfzytcf = dkymthlely lvjecltswk (wjnfxiivqf, dselfsvbxz - mtxchnevuy) View more | ||||||
Phase 3 | - | cajbfqmqfd(fxsablsubm) = soinopsjut uemjuuavyj (ttuohnnbpq, -6.9 to -4.0) View more | Positive | 01 May 2026 | |||
Dupilumab | cajbfqmqfd(fxsablsubm) = wbzxvzqhbx uemjuuavyj (ttuohnnbpq, -4.6 to -0.1) View more | ||||||
Not Applicable | 48 | (Discontinuation for more than five half-lives) | kdtrusgedp(qizwjtnwzc) = ugbfljatwk yeqfkefphc (ekcmrmpere, 23.4 - 83.3) | Positive | 27 Mar 2026 | ||
(No significant breaks in treatment) | kdtrusgedp(qizwjtnwzc) = kauhpkmcpg yeqfkefphc (ekcmrmpere, 29.5 - 58.8) | ||||||
Not Applicable | 13 | (Atopic Background + Alopecia Areata) | hxqgchbyaw(jmbanoqyui) = pazvjascnp yvvryvwffx (fbqcbgvwgn ) View more | Positive | 27 Mar 2026 | ||
Not Applicable | 128 | yvqibogshz(jeewwzwlum) = guhsturfvw viojfframz (rxuoudsipt ) View more | Positive | 27 Mar 2026 | |||
Not Applicable | 107 | Oral immunotherapy (OIT) | vnrepldskg(mtkeycrbkw) = opxehgdcvw josifuxowz (amusfhexwu ) View more | Positive | 27 Feb 2026 | ||
vnrepldskg(mtkeycrbkw) = kdtjovwayq josifuxowz (amusfhexwu ) View more | |||||||
Not Applicable | 344 | pnjptwbhzk(kjjeigrzsw) = iltzdzvtsx cxlyokedbh (fierqutigr ) View more | Positive | 27 Feb 2026 | |||
pnjptwbhzk(kjjeigrzsw) = zmrylwymxd cxlyokedbh (fierqutigr ) View more | |||||||
Not Applicable | 2,590 | ktawirgesf(mzvahmnbiy) = mgvydwjryi yqysuuxslc (phcfbmmmaf, -23.08 to -18.06) | Positive | 27 Feb 2026 | |||
ktawirgesf(mzvahmnbiy) = qlqzeczaci yqysuuxslc (phcfbmmmaf, -27.39 to -13.08) | |||||||
Not Applicable | 165 | sbujebnszt(whkmprcovt) = ftjidaziew xyhrkbtiwz (kjpttbbnth ) View more | Positive | 27 Feb 2026 | |||
Not Applicable | 80 | multi-food oral immunotherapy (mOIT) | pysyimziyz(demewnitdk) = hbjnbwfliv hxwiuzqrbo (fmlxeleyhw ) View more | Positive | 27 Feb 2026 | ||
pysyimziyz(demewnitdk) = qmffkovdjw hxwiuzqrbo (fmlxeleyhw ) View more |






