reslizumab

Trade name: cinqair

mAbapproved

Approved

Mar 23, 2016

Reslizumab, sold under the brand names Cinqair and Cinqaero, is a humanized monoclonal antibody against human interleukin-5 (IL-5). Reslizumab binds specifically to IL-5, a key cytokine responsible for the differentiation, maturation, recruitment and activation of human eosinophils. By binding to human IL-5, it blocks its biological function; consequently survival and activity of eosinophils are reduced. The benefits with reslizumab are its ability to reduce the exacerbation rate and improve lung function and asthma-related quality of life in patients with severe eosinophilic asthma and with at least one previous asthma exacerbation in the preceding year. The most common side effects are increased blood creatine phosphokinase, myalgia and anaphylactic reactions. — Wikipedia

Clinical trial activity

21 trials · 14 clinical orgs · 1 marketing orgs

Phase 1
2
Phase 2
15
Phase 3
12
Phase 4
2

Earliest trial started Jun 1, 2001 (NCT00017862)

Timeline

2000s

  1. Jan 1, 2001

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Jan 1, 2013

    Teva — Earliest Phase 1 Sponsor(trial)

  2. Mar 23, 2016

    Teva — Earliest FDA Approval

  3. Mar 23, 2016

    Teva — Marketing Organization

  4. Mar 23, 2016

    Teva — NDA Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedMar 23, 2016

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only
Multi-specific
No

Oral

No

Parenteral

Yes

Topical

No

Black box warning

Sources

Also known as

  • cep38072
  • cep-38072
  • cinqaero
  • cinqair
  • cinqair
  • cinqair
  • cinquil
  • dcp835
  • dcp-835
  • reslizumab
  • reslizumab
  • reslizumab
  • reslizumab
  • reslizumab
  • reslizumab
  • reslizumab
  • reslizumab
  • reslizumab
  • sch55700
  • sch55700
  • sch 55700
  • sch-55700
  • sch-55700
  • sch-55700

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04710134Phase 4Feb 10, 2021McMaster University, Teva
NCT04183192Phase 1Jan 31, 2020Food and Drug Administration, Spaulding Clinical Research Inc.
NCT03074942Phase 2May 1, 2017Hospital Universitario Lucus Augusti, Sociedad Española de Neumología y Cirugía Torácica
NCT02947945Phase 2May 1, 2017Teva, University of Colorado, Denver
NCT03052725Phase 3Mar 13, 2017Teva
NCT02937168Phase 4Feb 17, 2017Teva
NCT02799446Phase 3Jun 1, 2016Allergy and Asthma Clinical Research, CSL Behring
NCT02559791Phase 2/Phase 3 (Phase 3)Oct 1, 2015McMaster University, Teva, University of Western Ontario
NCT02501629Phase 3Sep 1, 2015Teva
NCT02452190Phase 3Sep 1, 2015PPD, Teva
NCT01990443Phase 1Jun 1, 2013Teva
NCT01508936Phase 3Feb 1, 2012Teva
NCT01290887Phase 3Jun 1, 2011Cephalon, Teva
NCT01287039Phase 3Apr 1, 2011Teva
NCT01285323Phase 3Mar 1, 2011Teva
NCT01270464Phase 3Feb 1, 2011Cephalon, Teva
NCT01111305Phase 2Apr 1, 2010National Institute of Allergy and Infectious Diseases (NIAID)
NCT00635089Phase 3Jul 1, 2008Cephalon, Ception
NCT00587288Phase 2Apr 1, 2008Cephalon, Ception
NCT00538434Phase 2/Phase 3 (Phase 3)Mar 1, 2008Cephalon, Ception
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (14)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
TevaFor profit131042011
CephalonFor profit5022008
CeptionFor profit3322008
McMaster UniversityAcademic/Hospital2222015
National Institute of Allergy and Infectious Diseases (NIAID)Government2212001
Allergy and Asthma Clinical ResearchAcademic/Hospital1012016
CSL BehringFor profit1112016
Food and Drug AdministrationGovernment1112020
Hospital Universitario Lucus AugustiAcademic/Hospital1012017
PPDFor profit1012015
Sociedad Española de Neumología y Cirugía TorácicaAcademic/Hospital1112017
Spaulding Clinical Research Inc.For profit1012020
University of Colorado, DenverAcademic/Hospital1112017
University of Western OntarioAcademic/Hospital1012015
14 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
TevaFor profitMKTGMar 23, 2016
TevaFor profitNDAMar 23, 2016