Safety and Efficacy of Meplazumab in Patients With Coronary Artery Disease: a Single-center, Triple-blinded, Placebo-controlled, Exploratory, Phase 2, Pilot Trial

The development of coronary atherosclerosis is closely related to inflammation, and CD147 may play an important role in its process. The present study was designed to evaluate the effects of long-term administration of mepolizumab (humanized anti-CD147 antibody) on lipid deposition and inflammation in coronary atherosclerotic plaques in patients with high-risk coronary artery disease, and to preliminarily explore the efficacy, safety, and dosage of long-term administration of mepolizumab in this population.

Start Date16 Oct 2024

Sponsor / Collaborator

Xijing Hospital

NCT06501807 / Not yet recruitingNot ApplicableIIT

Real Life Assessment of Biologics Efficacy in Severe Chronic Rhinosinusitis With Nasal Polyps

With a prevalence of 2-4% in western countries, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) is of major concern regarding its substantial impact on the social and physical quality of life. So far, endoscopic sinus surgery remains the treatment of choice when the first line of medical treatment with corticosteroid has failed.
During the last 15 years, several studies have shown that CRSwNP is associated with a T helper 2 (T2) immune response leading to B cell release of IgE, mucosal recruitment of eosinophils from bone marrow via Interleukin (IL)-5, IL-4 and IL-13 mediated chemoattractant production.
New biologic agents capable of blocking T2 cytokines have been developed in the field of eosinophil-associated diseases, shifting the paradigm of treatment for patients with CRSwNP. In the near future, endotype profiling with accurate biomarkers will be mandatory to tailor the treatment of nasal polyposis with specific biologic therapies.
Herein the investigators propose a prospective study monitoring medical records of CRSwNP patients who undergo biologic treatments. The objectives are to assess treatment efficacy on quality of life, to report clinical and biological criteria for prescription and to measure tolerance and compliance.Patient-reported outcomes will be addressed according to their initial clinical profile (allergy, asthma, NSAID, gastroesophageal reflux disease, obstructive apnea, otologic disorder, smoke habit).

Start Date02 Sep 2024

Sponsor / Collaborator-

CTIS2023-508069-34-01 / RecruitingIIT

Biomarkers for the prediction of individual CRSwNP patients' responses to mepolizumab

Start Date12 Aug 2024

Sponsor / Collaborator-

100 Clinical Results associated with Mepolizumab

100 Translational Medicine associated with Mepolizumab

100 Patents (Medical) associated with Mepolizumab

1,349

Literatures (Medical) associated with Mepolizumab

01 Jan 2025·JOINT BONE SPINE

Update on targeted treatments for ANCA-associated vasculitis

Article

Author: Puéchal, Xavier

Targeted therapy has revolutionized the management of ANCA-associated vasculitis (AAV) over the last fifteen years. Rituximab, an approved induction and maintenance agent for severe AAV, is no less effective than cyclophosphamide as induction therapy and particularly useful in relapsing or refractory disease, or in women. In patients with relapsing AAV, granulomatosis with polyangiitis or PR3-ANCA, it is more effective than cyclophosphamide. Rituximab maintenance is superior to the conventional immunosuppressive drugs that it replaces. Low-dose preemptive rituximab infusions are recommended every 6months for 18months, followed by re-evaluation to decide whether 4 additional biannual infusions should be administered, balancing the probability of relapse and the risk of serious infections on rituximab. A growing body of experimental and clinical data shows that C5a pathway inhibition is a promising therapeutic option for AAV, which could reduce glucocorticoids needs. Avacopan is a first approved oral C5A receptor antagonist, used when there is a high risk that glucocorticoids will cause serious adverse events. In eosinophilic granulomatosis with polyangiitis, the importance of IL-5 for eosinophil activation and survival led to evaluation and approval of mepolizumab, a humanized monoclonal antibody directed against IL-5. Mepolizumab showed a steroid-sparing effect. Its effectiveness in active vasculitis remains uncertain and is currently being evaluated. Benralizumab targeting the IL-5 receptor was recently shown to be noninferior to mepolizumab. Rituximab has had disappointing results in non-severe active vasculitis and is being evaluated as maintenance therapy. Plasma exchange is not indicated as first-line treatment but remains recommended when creatinine levels exceed 300μmol/L.

31 Dec 2024·Annals of medicine

Clinical characteristics of complete responders versus non-complete responders to omalizumab, benralizumab and mepolizumab in patients with severe asthma: a long-term retrospective analysis

Article

Author: Abad, Jorge ; Basagaña, Maria ; Carabias, Lídia ; Padró, Clara ; Pardo, Laura ; Roger, Albert ; Cardona Peitx, Gloria ; Rosell, Antoni ; Navarro, Juan ; Martínez-Rivera, Carlos ; Garcia-Olivé, Ignasi ; Cruz, Paula ; Martínez-Colls, Mimar

BACKGROUND:

Some patients with severe asthma may benefit from treatment with biologics, but evidence has been mostly collected from randomized controlled trials (RCTs), in which patients' characteristics are different from those encountered in asthma patients in the real-world setting. The aim of this study was to describe the clinical features of complete responders versus non-complete responders to long-term treatment with biologics in patients with severe asthma attended in routine daily practice.

METHODS:

Data of a cohort of 90 patients with severe asthma who were treated with biologics (omalizumab, benralizumab, and mepolizumab) for at least 12 months and were followed up to March 2022. Data recorded included clinical characteristics and effectiveness of treatment (exacerbation, Asthma Control Test [ACT] score, lung function, use of maintenance oral corticosteroids [mOCS]), FeNO, and blood eosinophils at baseline, at 12 months, and at the end of follow-up. Complete response is considered if, in addition to not presenting exacerbations or the use of mOCS, the ACT score was >20 and, the FEV₁ >80% predicted.

RESULTS:

An improvement in all asthma control parameters was observed after 12 months of treatment and a mean follow-up of 55 months. After 12 months of treatment 27.2% of patients met the criteria of complete response and this percentage even increased to 35.3% at the end of follow-up. Long-term complete response was associated to better lung function with mepolizumab and omalizumab treatment and to less previous exacerbations in the benralizumab group. The main cause of not achieving a complete response was the persistence of an airflow obstructive pattern.

CONCLUSIONS:

This study shows that omalizumab, benralizumab, and mepolizumab improved the clinical outcomes of patients with severe asthma in a clinic environment with similar effect sizes to RCTs in the long term follow-up. Airflow obstruction, however, was a predictor of a non-complete response to biologics.

31 Dec 2024·ANNALS OF MEDICINE

Improvement in health-related quality of life questionnaires with biologic treatment in severe asthma and comorbid chronic rhinosinusitis with or without nasal polyposis: a real-life experience

Article

Author: Santus, Pierachille ; Busatto, Paolo ; Danzo, Fiammetta ; Saad, Marina ; Radovanovic, Dejan ; Casartelli, Anna ; Lorusso, Rosaria ; Milani, Lisa

BACKGROUND:

Patients with severe asthma frequently have comorbid chronic rhinosinusitis (CRS) with or without nasal polyps, that can increase the symptom burden and complicate treatment. Real-life clinical data on the impact of biologic treatments on CRS-specific quality-of-life questionnaires are still lacking.

MATERIALS AND METHODS:

In this retrospective real-life study, we collected data from patients with severe asthma with comorbid CRS with/without nasal polyposis at baseline, and after 3, 6 and 12 months of treatment with omalizumab, mepolizumab, benralizumab or dupilumab. In particular, we evaluated improvements in HRQoL as measured by SinoNasal Outcome Test-22 (SNOT-22, 0 - 110), Visual Analog Scale symptom scores (VAS, 0-10), and Asthma Control Test (ACT, 5-25) and the proportion of patients meeting the minimal clinically important difference (MCID).

RESULTS:

Disease-specific HRQoL, as measured by SNOT 22 and VAS score improved in all patients at 3, 6, and 12 months of treatment compared with baseline (SNOT-22: 14, IQR: 0-52 vs 10, IQR:0-30 vs 0, IQR:0-15 vs 0, IQR:0-12, p < 0.001, VAS score: 1, IQR: 0-5 vs 0, IQR:0-3 vs 0, IQR:0-2 vs 0, IQR 0-1, p < 0.001). After 3 months of treatment >80% of patients reached the MCID for ACT, while only patients on dupilumab showed to reach a MCID in 100% of cases. The effect size depended upon the symptom burden at baseline.

CONCLUSIONS:

The study confirms the efficacy of omalizumab, mepolizumab, benralizumab, and dupilumab in a real-life setting, with a rapid improvement in CRS-specific HRQoL and general health status. These data highlight the importance of targeting type 2 inflammation in asthmatic patients with co-existing upper and lower airways disease.The Authors disclose that preliminary data and analysis of the present study have been presented in abstract form during the "X International Workshop on Lung Health - Respiratory Disease and Immune Response", held in Nice on 19-21 January 2023.

News (Medical) associated with Mepolizumab

16 hours ago

·www.prnewswire.com

Severe Asthma Clinical Trial Pipeline Appears Robust With 40+ Key Pharma Companies Actively Working in the Therapeutics Segment | DelveInsight

The severe asthma market is fueled by the rising prevalence of the condition, particularly in urban areas, alongside the emergence of innovative therapies like biologics targeting IgE and cytokine modulators. A growing demand for personalized medicine enhances treatment efficacy and patient compliance. Government initiatives and increased awareness improve access to care, while advancements in inhaler technology boost medication adherence. Collaborative efforts in R&D are also vital for driving innovation in asthma treatments. LAS VEGAS, Nov. 6, 2024 /PRNewswire/ -- DelveInsight's ' Severe Asthma Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline severe asthma therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the severe asthma pipeline domain. Key Takeaways from the Severe Asthma Pipeline Report DelveInsight's severe asthma pipeline report depicts a robust space with 40+ active players working to develop 50+ pipeline therapies for severe asthma treatment. Key severe asthma companies such as Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others are evaluating new severe asthma drugs to improve the treatment landscape. Promising severe asthma pipeline therapies such as KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others are under different phases of severe asthma clinical trials. In September 2024, Kinaset Therapeutics announced two oral presentations and a late-breaking poster presentation at the 2024 European Respiratory Society (ERS) Congress. The presentations demonstrate the potential of Kinaset's lead clinical candidate, frevecitinib ( KN-002), to treat all patients with moderate to severe asthma and patients with COPD. In May 2024, GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterized by blood eosinophil count. In April 2024, Twenty-five abstracts across approved and investigational medicines will be presented at this year's American Thoracic Society (ATS) International Conference. Notable data presentations for Sanofi's immunology pipeline include the first presentation of phase IIb moderate to severe asthma data for rilzabrutinib. In October 2023, Upstream Bio announced positive interim results in its Phase Ib clinical study of UPB-101, a thymic stromal lymphopoietin receptor (TSLPR) inhibitor. The Phase Ib study is a randomized, double-blinded, placebo-controlled multiple ascending dose (MAD) study with subcutaneous (SC) administration conducted in asthma patients. In October 2023, Aiolos Bio with an asthma drug in clinical trials, announced that it raised $245 million in Series A funding. Atlas Venture, Bain Capital Life Sciences, Forbion Capital Partners and Sofinnova Investments led the round, with additional investment from RA Capital Management Request a sample and discover the recent advances in severe asthma treatment drugs @ Severe Asthma Pipeline Report The severe asthma pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage severe asthma drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the severe asthma clinical trial landscape. Severe Asthma Overview Severe asthma is a chronic respiratory condition characterized by persistent symptoms that are difficult to control, even with high-dose medications. Unlike milder forms of asthma, severe asthma can significantly impair the quality of life and may result in frequent exacerbations requiring hospitalization. The exact cause of severe asthma is not entirely clear, but it often arises from a combination of genetic and environmental factors. These may include respiratory infections, allergens (pollen, mold, dust mites), pollutants (tobacco smoke, air pollution), occupational irritants, and lifestyle factors such as obesity and stress. Severe asthma can also develop in people whose milder asthma is not well-controlled over time. Diagnosis of severe asthma begins with a comprehensive medical history, physical examination, and pulmonary function tests like spirometry to assess lung function. Doctors may also order additional tests, such as chest X-rays, blood tests, and allergy tests to identify triggers. A key factor in diagnosing severe asthma is the persistence of symptoms despite the optimal use of standard asthma treatments. Managing severe asthma typically requires a multifaceted approach. Inhaled corticosteroids and long-acting bronchodilators are the mainstays of treatment. For those who do not respond to these medications, biologic therapies (such as omalizumab, mepolizumab, or dupilumab) may be prescribed to target specific pathways involved in the inflammatory response. In addition, patients with severe asthma may benefit from lifestyle modifications, including weight management, avoiding triggers, and pulmonary rehabilitation. In extreme cases, systemic corticosteroids may be necessary, although long-term use can have serious side effects. Find out more about severe asthma treatment drugs @ Drugs for Severe Asthma Treatment A snapshot of the severe asthma Pipeline Drugs mentioned in the report: Learn more about the emerging severe asthma pipeline therapies @ Severe Asthma Clinical Trials Severe Asthma Therapeutics Assessment The severe asthma pipeline report proffers an integral view of the severe asthma emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Severe Asthma Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Parenteral, Topical Therapeutics Assessment By Molecule Type: Recombinant fusion proteins, Small molecule, Monoclonal antibody, Peptide, Polymer, Gene therapy Therapeutics Assessment By Mechanism of Action: Interleukin 5 receptor antagonists, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin inhibitors, Thymic stromal lymphopoietin modulators, Interleukin 6 inhibitors, STAT6 transcription factor degraders, Interleukin 4 receptor alpha subunit antagonists Key Severe Asthma Companies: Kinaset Therapeutics, Bio-Thera Solutions, CSPC ZhongQi Pharmaceutical Technology, AB Science, GlaxoSmithKline, Oneness Biotech, Biosion, Lanier Biotherapeutics, Kymera Therapeutics, Suzhou Connect Biopharmaceuticals, Upstream Bio, Teva Branded Pharmaceutical Industries, Sanofi, Jiangsu Hengrui Medicine, AstraZeneca, Advagene Biopharma, Genrix (Shanghai) Biopharmaceuticals, and others. Key Severe Asthma Pipeline Therapies: KN-002, BAT2606, CM326, Masitinib, GSK3511294, FB 704A, BSI-045B, LNR 125.38, KT 621, CBP-201, Verekitug, TEV'248, Rilzabrutinib, SHR-1905, Atuliflapon, AD17002, GR1802, and others. Dive deep into rich insights for new drugs for severe asthma treatment, visit @ Severe Asthma Drugs Table of Contents For further information on the severe asthma pipeline therapeutics, reach out @ Severe Asthma Treatment Drugs Related Reports Severe Asthma Market Severe Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key severe asthma companies including AstraZeneca plc, GlaxoSmithKline plc, Sanofi S.A., Novartis AG, Roche Holding AG, Teva Pharmaceutical Industries Ltd., Merck & Co., Inc., Boehringer Ingelheim International GmbH, Regeneron Pharmaceuticals, Inc., Johnson & Johnson, Pfizer Inc., Bristol Myers Squibb, Eli Lilly and Company, Vertex Pharmaceuticals Incorporated, Amgen Inc., AbbVie Inc., Genentech, Inc., Gilead Sciences, Inc., Biogen Inc., CSL Limited, among others. Asthma Market Asthma Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key asthma companies including GlaxoSmithKline, 4D Pharma plc, AstraZeneca, Suzhou Connect Biopharmaceuticals, Avillion, Pearl Therapeutics, ARS Pharmaceuticals, Sinomab, Avalo Therapeutics, Kymab, Sanofi, Cumberland Pharmaceuticals, Genentech, Inc. , among others. Asthma Pipeline Asthma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, including clinical and non-clinical stage products, and the key asthma companies, including Jiangsu Hengrui Medicine, GlaxoSmithKline, Immunotek SL, AB Science, EMS, Avalo Therapeutics, Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd., ARS Pharmaceuticals, Sanofi, Zura Bio Ltd., AstraZeneca, EURRUS Biotech GmbH, T-Balance Therapeutics GmbH, Gossamer Bio, Aldeyra Therapeutics, Inc., Trio Medicines, Janssen Research & Development, Arrowhead Pharmaceuticals, Hoffman-La-Roche, GlaxoSmithKline, Biohaven Pharmaceutical, TAK-Circulator Co., Shanghai Hengrui Pharmaceutical, among others. Acute Respiratory Distress Syndrome Market Acute Respiratory Distress Syndrome Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key ARDS companies, including MediciNova, Edesa Biotech, Light Chain Biosciences, Boehringer Ingelheim, Genentech, Windtree Therapeutics, Biomarck Pharmaceuticals, Athersys, Healios, Direct Biologics, Biohaven Pharmaceutical, Arch Biopartners, APEPTICO Forschung und Entwicklung GmbH, Staidson (Beijing) Biopharmaceuticals, Veru, Mesoblast Limited, Avalo Therapeutics, Pluristem Therapeutics, ILTOO Pharma, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3Phase 1

05 Nov 2024

·pmlive.com

AstraZeneca’s Fasenra approved by EC to treat rare inflammatory disease EGPA

AstraZeneca’s Fasenra (benralizumab) has been approved by the European Commission (EC) to treat eosinophilic granulomatosis with polyangiitis (EGPA), a rare immune-mediated inflammatory disease that affects approximately 118,000 people globally. The drug has been specifically authorised by the regulator for use as an add-on treatment for adults with relapsing or refractory disease. Formerly known as Churg-Strauss syndrome, EGPA can result in damage to multiple organs, including the lungs, upper airway, skin, heart, gastrointestinal tract and nerves. Patients are often treated with chronic high-dose oral corticosteroids, but can experience recurrent relapses when they attempt to stop taking them. Fasenra, which is already approved in the EU as an add-on maintenance treatment for severe eosinophilic asthma, is designed to reduce the survival of eosinophils and basophils by interfering with interleukin-5 receptor binding. The EC’s latest decision on the drug follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the late-stage MANDARA study, in which patients were randomised to receive either a single 30mg subcutaneous injection of Fasenra, or three separate 100mg subcutaneous injections of mepolizumab every four weeks. Almost 60% of Fasenra-treated patients achieved remission, which was comparable to those receiving mepolizumab, and 41% of those being treated with Fasenra were able to fully taper off oral corticosteroids, compared to 26% in the mepolizumab arm. Ruud Dobber, executive vice president, biopharmaceuticals business unit, AZ, said: “[This] approval of Fasenra, with its convenient, single-monthly injection is a positive step forward for patients with EGPA. “Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.” The new authorisation comes less than two months after Fasenra received approval from the US Food and Drug Administration to treat adults with EGPA. The US regulator also approved the drug earlier this year for use in severe eosinophilic asthma patients aged six to 11 years with an eosinophilic phenotype.

Clinical ResultDrug ApprovalPhase 3

29 Oct 2024

·www.pharmaceutical-technology.com

EC approves AstraZeneca’s Fasenra for EGPA treatment

Results from the trial indicate that almost 60% of patients treated with Fasenra achieved remission. Credit: Mr. Ashi. Sae Yang/Shutterstock. The European Commission (EC) has approved AstraZeneca ‘s Fasenra (benralizumab) as an add-on therapy for adults with relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA), a condition previously known as Churg-Strauss syndrome. Fasenra is the second biologic approved for the condition. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and is supported by results from the MANDARA Phase III study. EGPA is an uncommon, immune-mediated vasculitis that results from inflammation of small to medium-sized blood vessels, potentially causing multi-organ damage. It can be perilous if left untreated. Almost 50% of patients with EGPA also suffer from severe eosinophilic asthma and often experience sinus and nasal symptoms. See Also: Novartis’ Scemblix gains FDA approval for leukaemia GSK to acquire Chimagen’s CMG1A46 for autoimmune disease AstraZeneca bioPharmaceuticals business unit executive vice-president Ruud Dobber stated: “Today’s approval of Fasenra, with its convenient, single-monthly injection, is a positive step forward for patients with EGPA. “Fasenra has been a well-established treatment for many years in thousands of people with severe eosinophilic asthma and we are pleased to now offer a much-needed treatment option for those living with EGPA in Europe.” The randomised, double-blinded, active-controlled MANDARA study evaluated Fasenra’s efficacy and safety against mepolizumab in adult subjects with relapsing or refractory EGPA. It marked the first head-to-head non-inferiority trial of biologics in this patient group. The trial enrolled 140 patients, randomised into a 1:1 ratio, who received either a single 30mg subcutaneous injection of Fasenra or three distinct 100mg injections of mepolizumab subcutaneously every four weeks. Almost 60% of patients treated with Fasenra achieved remission, a rate comparable to those treated with mepolizumab. 41% of patients treated with Fasenra completely narrowed down oral corticosteroids (OCS). The safety and tolerability profile in the MANDARA trial was consistent with the medicine’s known profile. Developed by AstraZeneca and in-licensed from BioWa, a subsidiary of Kyowa Kirin , Fasenra is approved in more than 80 countries and regions, including Japan, the US, the EU and China.

Clinical ResultDrug ApprovalPhase 3

100 Deals associated with Mepolizumab

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KEGG	Wiki	ATC	Drug Bank
D04923	Mepolizumab	R03DX09	DB06612

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Granulomatosis With Polyangiitis	CN	GlaxoSmithKline Trading Services Ltd.	19 Nov 2021
Eosinophilic Granuloma	JP	GlaxoSmithKline KK	25 Mar 2020
Eosinophilic Asthma	KR	GSK Plc	01 Apr 2016
Chronic rhinosinusitis with nasal polyps	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Chronic rhinosinusitis with nasal polyps	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Churg-Strauss Syndrome	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Hypereosinophilic Syndrome	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	EU	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	IS	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	LI	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Pulmonary Eosinophilia	NO	GlaxoSmithKline Trading Services Ltd.	01 Dec 2015
Asthma	US	GlaxoSmithKline LLC	04 Nov 2015

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Eosinophilia	Phase 3	GB	GSK Plc	07 Sep 2020
Eosinophilic Esophagitis	Phase 3	CN	GSK Plc	29 Aug 2018
Severe asthma	Phase 3	CN	GlaxoSmithKline Trading Services Ltd.	29 Aug 2018
Severe asthma	Phase 3	CN	GlaxoSmithKline (China) Investment Co., Ltd.	29 Aug 2018
Nasal Polyps	Phase 3	US	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	AR	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	AU	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	CA	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	DE	GSK Plc	25 May 2017
Nasal Polyps	Phase 3	NL	GSK Plc	25 May 2017

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Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00244686 (Pubmed) Manual	Phase 3	Severe asthma	514	Mepolizumab 100 mg SC (Adults/adolescents (≥12 years of age))	ezgdkdhlea(evgrpkcdct) = bjucvxfzgj xdgdujdaar (epjowavaif )	Positive	28 Oct 2024
				Mepolizumab 40 mg or 100 mg SC (bodyweight <40 or ≥40 kg, respectively) (Pediatric patients (6-11 years of age))	-
NCT04133909 (MATINEE, NEWS) Manual	Phase 3	Pulmonary Disease, Chronic Obstructive	-	Nucala	abpmrhnwcc(sdhizkpmgi) = The trial met its primary endpoint. irqshhlwal (lfjxbhcwqw ) Met View more	Positive	06 Sep 2024
				Placebo
EULAR2024 Manual	Not Applicable	Churg-Strauss Syndrome Maintenance \| Induction IL-5	48	Mepolizumab (maintenance phase for relapsing and refractory EGPA)	pzaxtivavb(cwcwdquzrq) = lwhebjdqvf hwbxmwlxeu (scnllvhxyb ) View more	Positive	05 Jun 2024
				Mepolizumab (in the remission induction phase for severe EGPA)	pzaxtivavb(cwcwdquzrq) = dpoklitkrv hwbxmwlxeu (scnllvhxyb ) View more
EULAR2024 Manual	Not Applicable	Eosinophilic Granuloma interleukin 5 (IL-5) \| IL-5α receptor	67	Mepolizumab 300 mg	zjtzdtzedb(aiszmzjemu) = vsgvytunok kuyvogljpt (loeztkbtkx ) View more	Positive	05 Jun 2024
				Mepolizumab 100 mg	zjtzdtzedb(aiszmzjemu) = vviuffqwdt kuyvogljpt (loeztkbtkx ) View more
EULAR2024	Not Applicable	Churg-Strauss Syndrome Maintenance MPO-ANCA-associated vasculitis (MPO-AAV)	25	MEPOLIZUMAB (Early administration group)	ewgeiyynbi(zikglldand) = 0 in both groups hniiqmkabn (ppgbhspclj ) View more	Positive	05 Jun 2024
				MEPOLIZUMAB (During maintenance group)
EULAR2024	Not Applicable	Churg-Strauss Syndrome	-	Mepolizumab 300mg	otolepfypv(kcspqbaaru) = A total of 118 patients were enrolled, 91% completed the study and 9% discontinued treatment. Of these, 55% were female, the mean (standard deviation [SD]) age was 62 (13.2) years and the mean (SD) time since diagnosis was 5.6 (4.4) years. Over 99% of patients had comorbidities at baseline (28% osteoporosis; 22% hypertension; 15% hyperlipidemia). Most patients (97%) used 300mg mepolizumab with a mean (SD) duration of 4.2 (0.68) years during the treatment period; 2 patients who continued from the MIRRA trial (NCT04551989) used mepolizumab for ≤7.4 years. AEs were reported in 69 patients (58%) and SAEs were reported in 26 patients (22%) over the observation period, infections were the most commonly reported (AEs: 36 patients [31%]; SAEs: 8 patients [7%]). There were no drug-related AEs. hawoqfijeo (arbmywmaab )	-	05 Jun 2024
NCT03298061 (LAP/MEA116841, ATS2024) Manual	Phase 3	Granulomatosis With Polyangiitis	100	Mepolizumab	xmbmmswezq(lqglrmjeks) = yhjiovggrc bvciopzizw (ujmycnsvyl )	Positive	19 May 2024
EHA2024	Not Applicable	Hypereosinophilic Syndrome Second line PDGFRΑ-negative	3	Mepolizumab	scdvslwxto(zjevokvjop) = zxzxzufkkw eklrsssgox (ebvztnssye )	Positive	14 May 2024
NCT03298061 (MEA116841 \| LAP/MEA116841, CTgov)	Phase 3	Churg-Strauss Syndrome	100	Mepolizumab	dphqehefjg(fixtkoiitx) = yjgfwqwamp malfktqjnu (lzhftnfgmi, prfiwahhsf - wwwjwynbne) View more	-	12 Mar 2024
Pubmed \| J Allergy Clin Immunol	Not Applicable	IL-5-driven eosinophilia	5	Mepolizumab 700 mg intravenously monthly for 3 months	odbdstiohv(lykhhhakib) = zclzhldpnm zjmbrzcozo (dxakvmnknb )	Negative	01 Mar 2024
				Mepolizumab 300 mg subcutaneously monthly	odbdstiohv(lykhhhakib) = wfbjfasyff zjmbrzcozo (dxakvmnknb )

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis