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Drug

Reslizumab

Approved · EMA
Emerging researchLate-stage development

Also known as Cinqair.

RxNorm1746889UNII35A26E427H
1
Research papers
1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

Clinical trial2024-04-22Results posted · ClinicalTrials.gov

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma and Persistent Sputum Eosinophilia Despite Standard Dose Therapy

Clinical trial2024-01-09Completed · ClinicalTrials.gov

A Randomized, Placebo-controlled, Double-Blind Pilot Study of Single-Dose Humanized Anti-IL5 Antibody (Reslizumab) for the Reduction of Eosinophilia Following Diethylcarbamazine Treatment of Loa Loa Infection

Clinical trial2022-01-27Results posted · ClinicalTrials.gov

A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group 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

Clinical trial2021-11-09Results posted · ClinicalTrials.gov

A 12-Month, Double-Blind, Placebo-Controlled, Parallel-Group 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

Clinical trial2021-11-09Results posted · ClinicalTrials.gov

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

Clinical trial2021-11-09Results posted · ClinicalTrials.gov

A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

Clinical trial2021-11-09Results posted · ClinicalTrials.gov

Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial

Clinical trial2019-07-01Primary completion · ClinicalTrials.gov

Open-Label, to Evaluate the Efficacy and Safety of Reslizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis (EGPA) Study: RITE Study

Clinical trial2018-12-01Primary completion · ClinicalTrials.gov

Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab: a Pilot Study

Clinical trial2018-04-30Completed · ClinicalTrials.gov

Approval: Cinqaero (EMA)

Regulatory2016-08-15EMA

Reslizumab in children and adolescents with eosinophilic esophagitis: results of a double-blind, randomized, placebo-controlled trial.

Research2011-12-28The Journal of allergy and clinical immunology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Reslizumab
Aliases & brands
Cinqair
RxNorm CUI
1746889
UNII
35A26E427H
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2016-08-15
Latest approval
2016-08-15
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2016-08-15Approval
Approval: Cinqaero (EMA)
Indication: Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal… Show full indication

Cinqaero is indicated as add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

20 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
20
registered trials across all phases
LATEST COMPLETION 2024
1
Active studies
1
Recruiting
14
Late-stage (III+)
15
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 20
Phase 12Phase 24Phase 2 / 32Phase 310Phase 42

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma and Persistent Sputum Eosinophilia Despite Standard Dose Therapy

CompletedPH IVMcMaster Universityn=102024

Distribution of Eosinophils in Asthma After Reslizumab (DEAR). A 7-Week, Placebo-Controlled, Double-Blinded, Parallel-Group, Imaging Study Using Positron Emission Tomography/Computer Tomography (PET/CT) to Characterize the Effect of Intravenous Reslizumab on Airway Inflammation in Patients With Eosinophilic Asthma

TerminatedPH IVTeva Branded Pharmaceutical Products R&D, Inc.n=52017

Efficacy of Reslizumab for the Treatment of Chronic Rhinosinusitis A Double Blind, Randomized, Placebo-controlled, Phase III Trial

Unknown statusPH IIIJoshua S. Jacobsn=302019

An Open-Label Extension Study of Reslizumab 110-mg Fixed, Subcutaneous Dosing in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

TerminatedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=3912018

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=4682018

Recent completions

Trials that read out recently, adding to the completed evidence base.

Efficacy of Reslizumab Dose Escalation in Patients With Severe Asthma and Persistent Sputum Eosinophilia Despite Standard Dose Therapy

CompletedPH IVMcMaster Universityn=102024

Pharmacodynamic Biomarkers to Support Biosimilar Development: Clinical Study 1: Interleukin-5 Antagonists - Mepolizumab and Reslizumab

CompletedPH IFood and Drug Administration (FDA)n=722021

Reslizumab in Patients With Severe Asthma Who Failed to Respond to Omalizumab: a Pilot Study

CompletedPH IISociedad Española de Neumología y Cirugía Torácican=302018

A 52-Week Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Reslizumab 110 mg Fixed, Subcutaneous Dosing in Patients With Uncontrolled Asthma and Elevated Blood Eosinophils

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=4682018

A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 Weeks) in Patients With Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

CompletedPH IIITeva Branded Pharmaceutical Products R&D, Inc.n=1772017

A Randomized, Placebo-controlled, Double-Blind Pilot Study of Single-Dose Humanized Anti-IL5 Antibody (Reslizumab) for the Reduction of Eosinophilia Following Diethylcarbamazine Treatment of Loa Loa Infection

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=312017

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • The Journal of allergy and clinical immunology1
Leading researchers
  • Abonia JP1
  • Collins MH1
  • Fuchs G 3rd1
  • Furuta GT1
  • Henkel T1
  • Liacouras CA1
  • Markowitz JE1
  • O'Gorman MA1
Leading institutions
free-text, unnormalised
  • Children's Hospital of Philadelphia1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.