Reslizumab

Generic Name
Reslizumab
Brand Names
Cinqair, Cinqaero
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

A Study to Evaluate the Efficacy and Safety of Reslizumab (3.0 mg/kg) in the Reduction of Clinical Asthma Exacerbations in Patients (12-75 Years of Age) With Eosinophilic Asthma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-02-01
Last Posted Date
2021-11-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
489
Registration Number
NCT01287039
Locations
🇺🇸

Teva Investigational Site 61, Los Angeles, California, United States

🇺🇸

Teva Investigational Site 51, Boston, Massachusetts, United States

🇵🇱

Teva Investigational Site 500, Ostrow Wielkopolski, Poland

and more 125 locations

A Study to Evaluate the Efficacy and Safety of Reslizumab in Patients With Eosinophilic Asthma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-01-28
Last Posted Date
2021-11-09
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
464
Registration Number
NCT01285323
Locations
🇩🇪

Teva Investigational Site 361, Berlin, Germany

🇬🇷

Teva Investigational Site 382, Heraklion, Crete, Greece

🇺🇸

Teva Investigational Site 69, El Paso, Texas, United States

and more 101 locations

A Study to Evaluate the Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) With Eosinophilic Asthma

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-01-05
Last Posted Date
2016-06-06
Lead Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
Target Recruit Count
315
Registration Number
NCT01270464
Locations
🇺🇸

Teva Investigational Site 16, Fort Worth, Texas, United States

🇦🇷

Teva Investigational Site 127, Ciudad Autonoma de Buenos Aire, Argentina

🇦🇷

Teva Investigational Site 123, Rosario-Santa Fe, Argentina

and more 86 locations

Reslizumab to Prevent Post-treatment Eosinophilia in Loiasis

First Posted Date
2010-04-27
Last Posted Date
2022-01-27
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
31
Registration Number
NCT01111305
Locations
🇺🇸

National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis

Phase 3
Completed
Conditions
Interventions
First Posted Date
2008-03-13
Last Posted Date
2017-03-23
Lead Sponsor
Ception Therapeutics
Target Recruit Count
190
Registration Number
NCT00635089
Locations
🇺🇸

Children's Center for Digestive Health Care, Atlanta, Georgia, United States

🇺🇸

Saint Louis University, St. Louis, Missouri, United States

🇺🇸

Nationwide Children's Hospital, Columbus, Ohio, United States

and more 33 locations
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