> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/mepolizumab-d54dc5ae-b70d-484f-859d-18a4f3f7efa5 > Record changed: 2026-10-13 # Mepolizumab Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) Drug type Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) First approval year 2015 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) ## Development status **First approval year** 2015 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) ## Names and chemistry **Drug type** Antibody Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) **Drug name** Mepolizumab Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) ### Brand names (4) - bosatria - Bosatria - nucala - Nucala ### Other names (33) - 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. ## Identifiers **ATC classification codes** - R03DX09 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) **CAS registry numbers** - 196078-29-2 **ChEMBL ID** CHEMBL2108429 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2108429) **PubChem compound IDs** - 56603701 **RxNorm IDs (RxCUI)** - 1720597 **FDA ingredient codes (UNII)** - 90Z2UF0E52 ## Regulatory information ### United States **Applicant** GLAXOSMITHKLINE LLC **Approval date** 4 Nov 2015 **Application number** BLA125526 ### European Union **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 Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/nucala) ### Other regulatory facts **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 ### Drug classification **Pharmacology name** mepolizumab **Type** Antibody **Drug name stem** \-mab; -mab **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (2) - **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 ### Investigated indications (12) - **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 ### Open Targets indications (32) - **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. ### Reported adverse events (107) - **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. ### Trial references (55) - NCT00086658 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00086658) - NCT00097370 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00097370) - NCT00244686 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00244686) - NCT02836496 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02836496) - NCT03306043 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03306043) - NCT04965636 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04965636) - NCT00274703 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00274703) - NCT00358449 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00358449) - NCT03656380 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03656380) - NCT00292877 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00292877) - NCT01000506 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01000506) - NCT01366521 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01366521) - NCT01471327 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01471327) - NCT01691508 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01691508) - NCT01691521 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01691521) - NCT01691859 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01691859) - NCT01842607 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01842607) - NCT02135692 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02135692) - NCT02281318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02281318) - NCT02377427 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02377427) - NCT02543112 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02543112) - NCT02555371 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02555371) - NCT02594332 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02594332) - NCT02654145 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02654145) - NCT03014674 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03014674) And 30 more, listed on the interactive page. ## Dosing **Dose** 100 mg **Route** Subcutaneous **How often** Every 4 weeks ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ## National Drug Codes - 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](https://trialight.com/data/condition/asthma-247437fb-0e60-5885-8a3a-ce40099cea88.md) - Chronic rhinosinusitis - Hypereosinophilic syndrome - Obstructive lung disease - Vasculitis ### In development for (7) - [Atopic eczema](https://trialight.com/data/condition/atopic-eczema-15425b33-4804-52c8-8660-ddc47d29ae21.md) Phase 2 - Chronic idiopathic urticaria Early phase 1 - [Chronic obstructive pulmonary disease](https://trialight.com/data/condition/chronic-obstructive-pulmonary-disease-8e23f74b-95b9-5920-a241-c0278555234f.md) 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](https://trialight.com/data/target/il5-090b670a-6302-57e3-be6b-fdf57248332c.md) Interleukin-5 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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