Mepolizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2015
- First approval year
- 2015
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Mepolizumab
- bosatria
- Bosatria
- nucala
- Nucala
- IMMUNOGLOBULIN G1 (HUMAN-MOUSE MONOCLONAL SB-240563 .GAMMA.1-CHAIN ANTI-HUMAN INTERLEUKIN 5), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL SB-240563 .KAPPA.-CHAIN, DIMER
- immunoglobulin g1 human mouse monoclonal sb 240563 gamma 1 chain anti human interleukin 5 disulfide with human mouse monoclonal sb 240563 kappa chain dimer
- mepolizumab
- Mepolizumab
- Mepolizumab (a-IL-5 antibody)
- mepolizumab [INN]
- MEPOLIZUMAB [JAN]
- MEPOLIZUMAB [MI]
- MEPOLIZUMAB [PURPLE BOOK CDER]
- MEPOLIZUMAB [USAN]
- Mepolizumab [WHO-DD]
- Mepolizumab 100 mg
- Mepolizumab 100 MG
- Mepolizumab 100 MG Injection
- Mepolizumab 100mg
- Mepolizumab 300 mg
- Mepolizumab Injection
- Mepolizumab Injection (BAT2606 Injection)
- Mepolizumab Injection (EU-licensed Nucala)
- Mepolizumab Injection (US-licensed Nucala)
- mepolizumab inn
- Mepolizumab IV
- mepolizumab jan
- mepolizumab mi
- mepolizumab purple book cder
And 8 more, listed on the interactive page.
- ATC classification codes
- R03DX09
Sources for recorded values
- CAS registry numbers
- 196078-29-2
- ChEMBL ID
- CHEMBL2108429
- PubChem compound IDs
- 56603701
- RxNorm IDs (RxCUI)
- 1720597
- FDA ingredient codes (UNII)
- 90Z2UF0E52
- Applicant
- GLAXOSMITHKLINE LLC
- Approval date
- 4 Nov 2015
- Application number
- BLA125526
- Status
- Authorised
- Status date
- 1 Dec 2015
- Authorisation date
- 1 Dec 2015
- Approved indications
- Severe eosinophilic asthma Nucala is indicated as an add-on treatment for severe refractory eosinophilic asthma in adults, adolescents and children aged 6 years and older . Chronic rhinosinusitis with nasal polyps (CRSwNP) Nucala is indicated as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP for whom therapy with systemic corticosteroids and/or surgery do not provide adequate control. Eosinophilic granulomatosis with polyangiitis (EGPA) Nucala is indicated as an add-on treatment for patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis (EGPA). Hypereosinophilic syndrome (HES) Nucala is indicated as an add-on treatment for adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause.
- Product number
- EMEA/H/C/003860
- Authorisation holder
- GlaxoSmithKline Trading Services Limited
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Asthma
European medicines record
- Patents
- 0
- Designations
- 1
- Earliest recorded loss of exclusivity
- 25 Sept 2027
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- mepolizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- IL-5
- Gene symbol
- IL-5
- Median affinity
- 11.38
- Affinity units
- pKd
- Primary target
- Yes
- Mechanism
- Interleukin-5 inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-5
- Protein identifier
- P05113
Open Targets mechanisms
- Mechanism
- Interleukin-5 inhibitor
- Action type
- Inhibitor
- Target
- Interleukin-5
- Condition
- Pulmonary Disease, Chronic Obstructive
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000341
- Subject identifier
- D029424
- Condition
- Eosinophilic Esophagitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004232
- Subject identifier
- D057765
- Condition
- Granulomatosis with Polyangiitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0005297
- Subject identifier
- D014890
- Condition
- Systemic Vasculitis
- Highest recorded phase
- 4
- Condition identifier
- EFO:0006803
- Subject identifier
- D056647
- Condition
- Churg-Strauss Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007208
- Subject identifier
- D015267
- Condition
- Chronic Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000024
- Subject identifier
- D002908
- Condition
- Nasal Polyps
- Highest recorded phase
- 3
- Condition identifier
- EFO:1000391
- Subject identifier
- D009298
- Condition
- Hypereosinophilic Syndrome
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001467
- Subject identifier
- D017681
- Condition
- Eosinophilia
- Highest recorded phase
- 2
- Condition identifier
- HP:0001880
- Subject identifier
- D004802
- Condition
- Lung Diseases, Obstructive
- Highest recorded phase
- 4
- Condition identifier
- HP:0006536
- Subject identifier
- D008173
- Condition
- Asthma
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Chronic Urticaria
- Highest recorded phase
- 0.5
- Condition identifier
- MONDO:0044212
- Subject identifier
- D000080223
- Condition identifier
- EFO_0000274
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000341
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004232
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005297
- Highest recorded phase
- 3
- Condition identifier
- EFO_0006803
- Condition identifier
- EFO_0007208
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000024
- Condition identifier
- EFO_1000391
- Highest recorded phase
- 3
- Condition identifier
- EFO_1001467
- Condition identifier
- EFO_1002029
- Condition identifier
- EFO_1002029
- Highest recorded phase
- 3
- Condition identifier
- HP_0002015
- Highest recorded phase
- 2
- Condition identifier
- HP_0006536
- Condition identifier
- HP_0006536
- Highest recorded phase
- 4
- Condition identifier
- HP_0100582
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004784
- Condition identifier
- MONDO_0004822
- Condition identifier
- MONDO_0004979
- Condition identifier
- MONDO_0004979
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0004980
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005002
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005010
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005361
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0006031
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0006314
- Highest recorded phase
- 3
And 7 more, listed on the interactive page.
- Event
- asthma
- Reports
- 1,664
- Reporting signal score
- 6,463.79
- Event
- asthma-chronic obstructive pulmonary disease overlap syndrome
- Reports
- 34
- Reporting signal score
- 173.903
- Event
- asthmatic crisis
- Reports
- 28
- Reporting signal score
- 88.7653
- Event
- blood count abnormal
- Reports
- 397
- Reporting signal score
- 1,440.39
- Event
- blood immunoglobulin e increased
- Reports
- 39
- Reporting signal score
- 124.817
- Event
- blood pressure increased
- Reports
- 88
- Reporting signal score
- 50.9804
- Event
- blood test abnormal
- Reports
- 99
- Reporting signal score
- 271.477
- Event
- breath sounds abnormal
- Reports
- 88
- Reporting signal score
- 306.036
- Event
- bronchial hyperreactivity
- Reports
- 15
- Reporting signal score
- 43.5053
- Event
- bronchial obstruction
- Reports
- 62
- Reporting signal score
- 256.113
- Event
- bronchial secretion retention
- Reports
- 33
- Reporting signal score
- 137.062
- Event
- bronchial wall thickening
- Reports
- 30
- Reporting signal score
- 127.992
- Event
- bronchiectasis
- Reports
- 109
- Reporting signal score
- 359.224
- Event
- bronchiolitis
- Reports
- 30
- Reporting signal score
- 72.9879
- Event
- broncholithiasis
- Reports
- 8
- Reporting signal score
- 46.7334
- Event
- bronchopulmonary aspergillosis allergic
- Reports
- 38
- Reporting signal score
- 172.515
- Event
- bronchospasm
- Reports
- 43
- Reporting signal score
- 57.5582
- Event
- cardiac murmur
- Reports
- 36
- Reporting signal score
- 65.4519
- Event
- chest discomfort
- Reports
- 281
- Reporting signal score
- 484.695
- Event
- chest x-ray abnormal
- Reports
- 24
- Reporting signal score
- 58.4376
- Event
- chronic obstructive pulmonary disease
- Reports
- 121
- Reporting signal score
- 208.373
- Event
- chronic sinusitis
- Reports
- 36
- Reporting signal score
- 105.127
- Event
- condition aggravated
- Reports
- 193
- Reporting signal score
- 100.216
- Event
- cough
- Reports
- 649
- Reporting signal score
- 1,119.67
- Event
- dyspnoea
- Reports
- 1,133
- Reporting signal score
- 1,779.91
And 82 more, listed on the interactive page.
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And 30 more, listed on the interactive page.
- Dose
- 100 mg
- Route
- Subcutaneous
- How often
- Every 4 weeks
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0173-0881
- 0173-0892
- 0173-0904
Related records
Trials (107)
- A Multi-center, Open-label Extension, Safety Study of Mepolizumab in Subjects With Hypereosinophilic Syndrome (HES) From Study 200622
- A Phase 3a, Repeat Dose, Open-label, Long-term Safety Study of Mepolizumab in Asthmatic Subjects
- A Pilot Study of the Use of 129Xe and 1H MRI to Measure the Modulation of Eosinophil-Related Inflammation by Mepolizumab In COPD
- A Pragmatic Study to Investigate the Efficacy and Safety of Mepolizumab in Severe Uncontrolled Asthma in Brazil
- A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps
- A Safety and Efficacy Study of Mepolizumab in Subjects With Severe Asthma
- A Study of GSK3511294 (Depemokimab) Compared With Mepolizumab or Benralizumab in Participants With Severe Asthma With an Eosinophilic Phenotype
- A Study on the Effect of Mepolizumab Therapy on Daily Physical Activity of Patients With Severe Eosinophilic Asthma
- A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects
- A Study to Evaluate the Efficacy and Safety of SHR-1703 in Subjects With Eosinophilic Granulomatosis With Polyangiitis （EGPA）
- A Study to Investigate Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis
- A Trial of Mepolizumab Adjunctive Therapy for the Prevention of Asthma Exacerbations in Urban Children
- Aggravated Airway Inflammation: Research on Biological Treatment (Mepolizumab)
- Airway Dysfunction, Occlusions and Remodeling: COPD Patients and Mepolizumab
- An Evaluation Of Mepolizumab In Therapy Of Eosinophilic Oesophagitis In Adult Patients
- Anti-IL-5 Therapy in Bullous Pemphigoid (BP)
- Anti-IL-5 Therapy With Simple Polypectomy Versus Extended Endoscopic Sinus Surgery for CRSwNP
- Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome
- Beyond EOsinophils: proteoMICS to Identify Potential Biomarker of Organ Damage and Response to MEPOLIZUMAB in EGPA
- BIOlogics in Severe Nasal POlyposis SurvEy
Approved for (5)
- Asthma
- Chronic rhinosinusitis
- Hypereosinophilic syndrome
- Obstructive lung disease
- Vasculitis
In development for (7)
- Atopic eczema Phase 2
- Chronic idiopathic urticaria Early phase 1
- Chronic obstructive pulmonary disease Phase 3
- Eosinophilic esophagitis Phase 2
- Eosinophilic granulomatosis with polyangiitis Phase 3
- Granulomatosis with polyangiitis Phase 3
- Nasal cavity polyp Phase 3
Targets (1)
- IL5 Interleukin-5 inhibitor