MedPath

Reslizumab

Generic Name
Reslizumab
Brand Names
Cinqair, Cinqaero
Drug Type
Biotech
CAS Number
241473-69-8
Unique Ingredient Identifier
35A26E427H
Background

Reslizumab is a humanized interleukin-5 (IL-5) antagonist monoclonal antibody (IgG4 kappa) that is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells. IL-5 is a pro-inflammatory cytokine that is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils . Elevated levels of eosinophils increase the risk for asthma exacerbations, including both allergic forms and nonallergic forms of asthma where eosinophilia is prominent. By targeting the IL-5 and disrupting its signalling pathways, reslizumab aims to inhibit eosinophil maturation and promote programmed cell death .

Asthma is a chronic respiratory disease that causes inflammation in the lungs with asthma attacks that lead to severe breathing difficulties. Patients often experience persistent or exacerbating symptoms overtime despite conventional first-line therapies available. Inflammation-predominant asthma, which is chatacterized by eosinophilic infiltration of airway mucosa and elevated levels of eosinophils in the blood, sputum and BAL fluid, is associated with an increased risk for recurrent exacerbation and asthma-related hospitalizations . In four double-blind, randomized, placebo‑controlled trials in patients with severe asthma on currently available therapies, patients receiving reslizumab had fewer asthma attacks, and a longer time to the first attack compared to patients receiving placebo . In addition, a significant improvement in lung function was seen, as measured by the volume of air exhaled by patients in one second . Studies demonstrated that reslizumab was not effective in various asthma outcomes in patients without eosinophilia .

Reslizumab was developed by Teva Pharmaceuticals. Approved by the FDA in March 2016, reslizumab is marketed under the brand name Cinqair for intravenous injection. It is injected once every four weeks via intravenous infusion. Cinqair is indicated as an add-on maintenance therapy for adults with severe asthma with an eosinophilic phenotype. It is approved for patients who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. Reslizumab is marketed as Cinqaero in Europe.

Indication

Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.

Associated Conditions
Severe Eosinophilic Asthma

Study of Chronic Rhinosinusitis Symptoms in Asthma Patients Undergoing Treatment With Reslizumab

Withdrawn
Conditions
Nasal Polyps
Chronic Rhinosinusitis (Diagnosis)
Asthma
Interventions
First Posted Date
2017-12-12
Last Posted Date
2019-11-13
Lead Sponsor
University of Rochester
Registration Number
NCT03369574
Locations
🇺🇸

University of Rochester Department of Otolaryngology Head and Neck Surgery, Rochester, New York, United States

Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab

Phase 2
Completed
Conditions
Severe Asthma
Interventions
First Posted Date
2017-03-09
Last Posted Date
2018-05-16
Lead Sponsor
Sociedad Española de Neumología y Cirugía Torácica
Target Recruit Count
30
Registration Number
NCT03074942
Locations
🇪🇸

Hospital Universitario de Cruces, Barakaldo, Bizkaia, Spain

🇪🇸

Hospital de Sabadell, Sabadell, Barcelona, Spain

🇪🇸

Hospital Universitari Son Espases, Palma, Islas Baleares, Spain

and more 7 locations

A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

Phase 3
Terminated
Conditions
Eosinophils, Asthma
Interventions
First Posted Date
2017-02-14
Last Posted Date
2022-12-14
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
391
Registration Number
NCT03052725
Locations
🇺🇸

Teva Investigational Site 14651, Chicago, Illinois, United States

🇧🇪

Teva Investigational Site 37083, Gent, Belgium

🇵🇱

Teva Investigational Site 53399, Krakow, Poland

and more 131 locations

Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study

Phase 2
Conditions
Asthma
Interventions
First Posted Date
2016-10-28
Last Posted Date
2017-09-14
Lead Sponsor
National Jewish Health
Target Recruit Count
10
Registration Number
NCT02947945
Locations
🇺🇸

National Jewish Health, Denver, Colorado, United States

An Imaging Study Using PET/CT to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation

Phase 4
Terminated
Conditions
Asthma
Interventions
First Posted Date
2016-10-18
Last Posted Date
2021-11-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
5
Registration Number
NCT02937168
Locations
🇺🇸

Teva Investigational Site 13808, New Brunswick, New Jersey, United States

Effect of Reslizumab in Chronic Rhinosinusitis

Phase 3
Conditions
Sinusitis
Interventions
Drug: Placebo
First Posted Date
2016-06-14
Last Posted Date
2018-02-01
Lead Sponsor
Joshua S. Jacobs
Target Recruit Count
30
Registration Number
NCT02799446
Locations
🇺🇸

Allergy and Asthma Clinical Research, Walnut Creek, California, United States

An Efficacy and Safety Study of Reslizumab Subcutaneous in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Phase 3
Completed
Conditions
Elevated Blood Eosinophils
Oral Corticosteroid Dependence
Asthma
Interventions
Drug: Placebo
Drug: Non-Oral Corticosteroid (non-OCS) Asthma Medication
Drug: Oral Corticosteroid (OCS)
First Posted Date
2015-07-17
Last Posted Date
2021-11-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
177
Registration Number
NCT02501629
Locations
🇺🇸

Teva Investigational Site 13349, Cincinnati, Ohio, United States

🇺🇸

Teva Investigational Site 13357, Bakersfield, California, United States

🇺🇸

Teva Investigational Site 13365, Long Beach, California, United States

and more 124 locations

Study of Reslizumab in Participants With Uncontrolled Asthma and Elevated Blood Eosinophils

Phase 3
Completed
Conditions
Asthma
Interventions
Drug: Placebo
First Posted Date
2015-05-22
Last Posted Date
2021-11-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
468
Registration Number
NCT02452190
Locations
🇺🇸

Teva Investigational Site 13215, Bakersfield, California, United States

🇺🇸

Teva Investigational Site 13235, Shiloh, Illinois, United States

🇺🇸

Teva Investigational Site 13208, Tallahassee, Florida, United States

and more 223 locations

Absolute Bioavailability of Reslizumab in Healthy Subjects

Phase 1
Completed
Conditions
Absolute Bioavailability
Interventions
First Posted Date
2013-11-21
Last Posted Date
2014-03-31
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
75
Registration Number
NCT01990443
Locations
🇺🇸

Teva Investigational Site 10567, Anaheim, California, United States

Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma

Phase 3
Completed
Conditions
Eosinophilic Asthma
Interventions
Drug: Placebo
First Posted Date
2012-01-12
Last Posted Date
2016-06-27
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
511
Registration Number
NCT01508936
Locations
🇺🇸

Investigational Site 865, Miami, Florida, United States

🇺🇸

Investigational Site 881, Miami, Florida, United States

🇺🇸

Investigational Site 809, Tucson, Arizona, United States

and more 62 locations
© Copyright 2025. All Rights Reserved by MedPath