Omalizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2003
- First approval year
- 2003
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Omalizumab
- omlyclo
- Omlyclo
- xolair
- Xolair
- ct p39
- Ct-p39
- CT-P39
- ctp 39
- CTP-39
- ctp39
- CTP39
- Drug: Omalizumab
- gbr 310
- GBR 310
- Gbr-310
- hs632
- Hs632
- HS632
- ige25
- IGE25
- Immunoglobulin G (human-mouse monoclonal E25 clone pSV1E26 -chain antihuman immunoglobulin E Fc region), disulfide with human-mouse monoclonal E25 clone pSVIE126 -chain, dimer
- immunoglobulin g anti human immunoglobulin e fc region human mouse monoclonal e25 clone psvie26 chain disulfide with human mouse monoclonal e25 clone psvie26 chain dimer
- immunoglobulin g human mouse monoclonal e25 clone psv1e26 chain antihuman immunoglobulin e fc region disulfide with human mouse monoclonal e25 clone psvie126 chain dimer
- Immunoglobulin G, anti-(human immunoglobulin E Fc region) (human-mouse monoclonal E25 clone pSVIE26 -chain), disulfide with human-mouse monoclonal E25 clone pSVIE26 -chain, dimer
- olizumab
- OLIZUMAB
- omalizumab
- Omalizumab
- OMALIZUMAB
And 52 more, listed on the interactive page.
- ATC classification codes
- R03DX05
Sources for recorded values
- CAS registry numbers
- 242138-07-4
- ChEMBL ID
- CHEMBL1201589
- RxNorm IDs (RxCUI)
- 302379
- FDA ingredient codes (UNII)
- 2P471X1Z11
- Applicant
- GENENTECH
- Approval date
- 20 Jun 2003
- Application number
- BLA103976
- Status
- Authorised
- Status date
- 25 Oct 2005
- Authorisation date
- 25 Oct 2005
- Approved indications
- Allergic asthma Xolair is indicated in adults, adolescents and children (6 to <12 years of age). Xolair treatment should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma. Adults and adolescents (12 years of age and older) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and who have reduced lung function (FEV1 <80%) as well as frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Children (6 to <12 years of age) Xolair is indicated as add-on therapy to improve asthma control in patients with severe persistent allergic asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and frequent daytime symptoms or night-time awakenings and who have had multiple documented severe asthma exacerbations despite daily high-dose inhaled corticosteroids, plus a long-acting inhaled beta2-agonist. Chronic rhinosinusitis with nasal polyps (CRSwNP) Xolair is indicated as an add-on therapy with intranasal corticosteroids (INC) for the treatment of adults (18 years and above) with severe CRSwNP for whom therapy with INC does not provide adequate disease control. Chronic spontaneous urticaria (CSU) Xolair is indicated as add-on therapy for the treatment of chronic spontaneous urticaria in adult and adolescent (12 years and above) patients with inadequate response to H1 antihistamine treatment.
- Product number
- EMEA/H/C/000606
- Authorisation holder
- Novartis Europharm Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 1
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Asthma
- Rhinitis
- Urticaria
European medicines record
- Patents
- 0
- Designations
- 2
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- omalizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- immunoglobulin heavy constant epsilon
- Gene symbol
- IGHE
- Protein identifier
- P01854
- Median affinity
- 8.16
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Ig epsilon chain C region inhibitor
- Action type
- Inhibitor
- Target
- Immunoglobulin heavy constant epsilon
- Protein identifier
- P01854
Open Targets mechanisms
- Mechanism
- Ig epsilon chain C region inhibitor
- Action type
- Inhibitor
- Target
- Immunoglobulin heavy constant epsilon
- Condition
- Dermatitis, Atopic
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000274
- Subject identifier
- D003876
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Immune System Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000540
- Subject identifier
- D007154
- Condition
- Rhinitis, Allergic, Seasonal
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003956
- Subject identifier
- D006255
- Condition
- Eosinophilic Esophagitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004232
- Subject identifier
- D057765
- Condition
- Urticaria
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005531
- Subject identifier
- D014581
- Condition
- Angioedema
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005532
- Subject identifier
- D000799
- Condition
- Rhinitis, Allergic, Seasonal
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005854
- Subject identifier
- D006255
- Condition
- Pemphigoid, Bullous
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007187
- Subject identifier
- D010391
- Condition
- Milk Hypersensitivity
- Highest recorded phase
- 2
- Condition identifier
- EFO:0007369
- Subject identifier
- D016269
- Condition
- Peanut Hypersensitivity
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007425
- Subject identifier
- D021183
- Condition
- Sinusitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007486
- Subject identifier
- D012852
- Condition
- Cystitis, Interstitial
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008507
- Subject identifier
- D018856
- Condition
- Rhinitis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0008521
- Subject identifier
- D012220
- Condition
- Drug Hypersensitivity
- Highest recorded phase
- 1
- Condition identifier
- EFO:0009482
- Subject identifier
- D004342
- Condition
- Bronchitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0009661
- Subject identifier
- D001991
- Condition
- Chronic Inducible Urticaria
- Highest recorded phase
- 2
- Condition identifier
- EFO:1000685
- Subject identifier
- D000094482
- Condition
- Gastroenteritis
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001463
- Subject identifier
- D005759
- Condition
- Cold Urticaria
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001881
- Subject identifier
- D000096703
- Condition
- Food Hypersensitivity
- Highest recorded phase
- 2
- Condition identifier
- EFO:1001890
- Subject identifier
- D005512
- Condition
- Lung Diseases, Obstructive
- Highest recorded phase
- 4
- Condition identifier
- HP:0006536
- Subject identifier
- D008173
- Condition
- Nephritis, Interstitial
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001085
- Subject identifier
- D009395
- Condition
- Asthma
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Hypersensitivity
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005271
- Subject identifier
- D006967
- Condition
- Lupus Erythematosus, Systemic
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0007915
- Subject identifier
- D008180
And 4 more, listed on the interactive page.
- Condition identifier
- EFO_0000274
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000341
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000540
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003956
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004232
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005531
- Condition identifier
- EFO_0005532
- Highest recorded phase
- 3
- Condition identifier
- EFO_0005854
- Condition identifier
- EFO_0007187
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007248
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007369
- Highest recorded phase
- 2
- Condition identifier
- EFO_0007425
- Highest recorded phase
- 3
- Condition identifier
- EFO_0007486
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008507
- Highest recorded phase
- 3
- Condition identifier
- EFO_0008521
- Condition identifier
- EFO_0009482
- Highest recorded phase
- 1
- Condition identifier
- EFO_0009661
- Condition identifier
- EFO_1000391
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000685
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001243
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001463
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001881
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001890
- Highest recorded phase
- 3
- Condition identifier
- EFO_1002029
- Highest recorded phase
- 3
- Condition identifier
- HP_0000789
- Highest recorded phase
- 2
And 39 more, listed on the interactive page.
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Warning
- Black Box Warning
- Effect
- dermatological toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- immune system toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- neurotoxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- respiratory toxicity
- Country
- United States
- Warning
- Black Box Warning
- Effect
- vascular toxicity
- Country
- United States
- Event
- alopecia
- Reports
- 568
- Reporting signal score
- 342.267
- Event
- anaphylactic reaction
- Reports
- 1,852
- Reporting signal score
- 3,663.53
- Event
- angioedema
- Reports
- 706
- Reporting signal score
- 782.816
- Event
- arthralgia
- Reports
- 1,295
- Reporting signal score
- 545.501
- Event
- asthma
- Reports
- 3,906
- Reporting signal score
- 10,702.6
- Event
- asthmatic crisis
- Reports
- 146
- Reporting signal score
- 437.139
- Event
- blood immunoglobulin e increased
- Reports
- 318
- Reporting signal score
- 1,102.53
- Event
- blood pressure increased
- Reports
- 944
- Reporting signal score
- 959.704
- Event
- blood pressure systolic increased
- Reports
- 544
- Reporting signal score
- 1,164.53
- Event
- body temperature decreased
- Reports
- 324
- Reporting signal score
- 697.749
- Event
- breath sounds abnormal
- Reports
- 158
- Reporting signal score
- 355.976
- Event
- bronchitis
- Reports
- 646
- Reporting signal score
- 688.505
- Event
- bronchospasm
- Reports
- 275
- Reporting signal score
- 374.445
- Event
- chest discomfort
- Reports
- 1,019
- Reporting signal score
- 1,242.02
- Event
- chronic spontaneous urticaria
- Reports
- 151
- Reporting signal score
- 590.955
- Event
- cough
- Reports
- 1,945
- Reporting signal score
- 1,994.14
- Event
- dyspnoea
- Reports
- 3,139
- Reporting signal score
- 2,451.49
- Event
- dyspnoea exertional
- Reports
- 403
- Reporting signal score
- 481.931
- Event
- erythema
- Reports
- 734
- Reporting signal score
- 398.032
- Event
- fatigue
- Reports
- 1,692
- Reporting signal score
- 350.679
- Event
- forced expiratory volume decreased
- Reports
- 739
- Reporting signal score
- 2,975.78
- Event
- forced vital capacity decreased
- Reports
- 87
- Reporting signal score
- 295.637
- Event
- headache
- Reports
- 1,499
- Reporting signal score
- 364.508
- Event
- heart rate increased
- Reports
- 722
- Reporting signal score
- 896.282
- Event
- hypersensitivity
- Reports
- 1,057
- Reporting signal score
- 841.608
And 37 more, listed on the interactive page.
- NCT00046748
- NCT00079937
- NCT00096954
- NCT00109187
- NCT00109200
- NCT00133042
- NCT00162773
- NCT00180011
- NCT00219323
- NCT00232050
- NCT00264849
- NCT00314574
- NCT00329381
- NCT00377572
- NCT00401596
- NCT00454051
- NCT00482248
- NCT00482508
- NCT00495612
- NCT00500539
- NCT00546143
- NCT00567476
- NCT00624832
- NCT00639691
- NCT00657891
And 85 more, listed on the interactive page.
- Dose
- 75-600 mg
- Route
- Subcutaneous
- How often
- Every 2 or 4 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Sequence
- Type
- Protein
- Sequence
- DIQLTQSPSSLSASVGDRVTITCRASQSVDYDGDSYMNWYQQKPGKAPKLLIYAASYLESGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCQQSHEDPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNR
- Component
- Sequence
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGGSLRLSCAVSGYSITSGYSWNWIRQAPGKGLEWVASITYDGSTNYADSVKGRFTISRDDSKNTFYLQMNSLRAEDTAVYYCARGSHYFGHWHFAVWGQGTLVTVSSGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKAEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- 50242-040
- 50242-214
- 50242-215
- 50242-227
- 72606-035
- 72606-036
- 72606-054
Related records
Trials (201)
- A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitis With Nasal Polyps
- A Clinical Trial of Omalizumab in Participants With Chronic Rhinosinusitus With Nasal Polyps
- A Compassionate Access Protocol to Assess the Safety of XolairTM (Omalizumab) in Patients (≥ 6 Years Old) With Severe Allergic Asthma Who Remain Symptomatic Despite Optimal Therapy
- A Continued Access Protocol to Provide Xolair to Patients With Severe Allergic Asthma
- A Description of Inflammatory Cell Types In Moderate to Severe Pediatric Asthma: Eosinophilic and Non Eosinophilic Sputum Markers While on Anti-IgE Therapy
- A FIH Study of YH35324 in Atopic Healthy Subjects or Subjects with Mild Allergic Diseases
- A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases
- A Phase 1, Randomized, Placebo-controlled, Dose-escalation Safety Study of MEDI4212 in Subjects With IgE >= 30 IU/mL
- A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.
- A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines
- A Pilot Study Investigating the Effect of Omalizumab (Xolair) in Work-Related Animal Induced Asthma
- A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab
- A Prospective Study on Optimizing Treatment for ABPA
- A Prospective, Randomized, Double-Blind Study of the Efficacy of Omalizumab (Xolair) in Atopic Asthmatics With Good Lung Capacity Who Remain Difficult to Treat (EXACT)
- A Randomized, Double-Blind, Placebo-Controlled Study of Omalizumab for Idiopathic Anaphylaxis
- A Safety and Efficacy Study of Xolair in Peanut Allergy
- A Safety Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic Despite Treatment With H1 Antihistamines, H2 Blockers, and/or Leukotriene Receptor Antagonists
- A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases
- A Study Evaluating the Efficacy of QGE031 Compared to Omalizumab in Patients With Allergic Asthma
- A Study Evaluating the Persistency of Response With or Without Xolair (Omalizumab) After Long-term Therapy
Approved for (4)
In development for (25)
- Allergic asthma Phase 3
- Allergic disease Phase 2
- Allergic rhinitis Phase 3
- Angioedema Phase 3
- Atopic eczema Phase 1
- Bronchitis Phase 2
- Bullous pemphigoid Phase 2
- Chronic idiopathic urticaria Phase 3
- Chronic obstructive pulmonary disease Phase 2
- Cold urticaria Phase 2
- COVID-19 Phase 2
- Drug allergy Phase 1
- Eosinophilic esophagitis Phase 2
- Familial dermatographia Phase 2
- Food allergy Phase 2
- Gastroenteritis Phase 2
- Hyper-IgE recurrent infection syndrome 1, autosomal dominant Phase 1
- Immune system disorder Phase 2
- Interstitial cystitis Phase 3
- Interstitial nephritis Phase 2
Targets (1)
- IGHE Ig epsilon chain C region inhibitor