Drugs / Reslizumab
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Cinqaero | — | 2016-08-15 | europa.eu ↗ |
| Approved | US (FDA) | CINQAIR | — | 2016-03-23 | fda.gov ↗ |
Trials 19 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT04183192 | Feb 2020 → Apr 2021 | — | Food and Drug Administration (FDA) | Completed | No outcome recorded |
| Phase 1 | NCT01990443 | Jun → Dec 2013 | — | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT02947945 | Sep 2017 → Dec 2018 overdue | asthma | National Jewish Health | Recruiting | No outcome recorded |
| Phase 2 | NCT03074942 | Apr 2017 → Mar 2018 | asthma | Sociedad Española de Neumología y Cirugía Torácica | Completed | No outcome recorded |
| Phase 2 | NCT00587288 | Apr 2008 → Mar 2010 | asthma | Ception Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00017862 | Jun 2001 → Jun 2003 | hypereosinophilic syndrome | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT02559791 | Oct 2015 → Apr 2017 | chronic asthma, chronic bronchitis | McMaster University | Completed | No outcome recorded |
| Phase 2/3 | NCT00538434 | Mar 2008 → Oct 2009 | eosinophilic esophagitis | Ception Therapeutics | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT03052725 | Mar 2017 → Feb 2018 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02799446 | Jun 2016 → Jul 2019 | sinusitis | Joshua S. Jacobs | Unknown | No outcome recorded |
| Phase 3 | NCT02501629 | Sep 2015 → Jun 2017 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02452190 | Sep 2015 → Dec 2017 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01508936 | Feb 2012 → Aug 2013 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01290887 | Jun 2011 → Jan 2015 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01287039 | Apr 2011 → Dec 2013 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01285323 | Mar 2011 → Apr 2014 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01270464 | Feb 2011 → Sep 2013 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00635089 | Jul 2008 → Jan 2012 | eosinophilic esophagitis | Ception Therapeutics | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02937168 | May 2017 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT01111305 Comparator | Apr 2010 → Jan 2016 | loiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04710134 Comparator | Feb 2021 → Jan 2024 | asthma | McMaster University | Completed | No outcome recorded |
Press releases naming this drug 12 releases
| Date | Issuer | Release |
|---|---|---|
| 2018-01-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosinophilic Asthma tevapharm.com ↗ |
| 2017-07-20 | Teva Branded Pharmaceutical Products R&D, Inc. | NICE Recommends CINQAERO® (reslizumab) for the Treatment of Severe Eosinophilic Asthma tevapharm.com ↗ |
| 2016-08-18 | Teva Branded Pharmaceutical Products R&D, Inc. | European Commission Grants Marketing Authorization for Teva’s CINQAERO® (reslizumab) tevapharm.com ↗ |
| 2016-06-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Receives CHMP Positive Opinion for CINQAERO® (reslizumab) tevapharm.com ↗ |
| 2016-03-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Approval of CINQAIR® (reslizumab) Injection tevapharm.com ↗ |
| 2015-12-10 | Teva Branded Pharmaceutical Products R&D, Inc. | FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab tevapharm.com ↗ |
| 2015-09-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Presents New Reslizumab Data at European Respiratory Society (ERS) International Congress 2015 tevapharm.com ↗ |
| 2015-07-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces European Medicines Agency (EMA) Confirms Successful Validation of Reslizumab Marketing Authorization Application tevapharm.com ↗ |
| 2015-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces FDA Acceptance of the Biologics License Application for Reslizumab tevapharm.com ↗ |
| 2015-02-23 | Teva Branded Pharmaceutical Products R&D, Inc. | The Lancet Respiratory Medicine and AAAAI Publish Positive Data from Phase III Trials of Teva’s Reslizumab for the Treatment of Moderate to Severe Asthma in Patients with Elevated Blood Eosinophils tevapharm.com ↗ |
| 2014-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Successful Completion of Phase III Program for Teva’s Reslizumab Two More Phase Iii Studies Support the Benefits of Reslizumab Treatment in Asthma Patients with Eosinophilia tevapharm.com ↗ |
| 2014-09-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva’s Reslizumab Delivers Clinically and Statistically Significant Reduction in Asthma Exacerbations in Two Pivotal Phase III Studies tevapharm.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 23 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Reslizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01285323 ↗ |
| Known as | CEP-38072 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107884 ↗ |
| Known as | Cinqaero | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107884 ↗ |
| Known as | Cinqair | “Reslizumab/Cinqair is an approved/marketed product administered monthly by intravenous to severe eosinophilic asthmatics at 3mg/kg.” NCT04710134 ↗ |
| Known as | Cinquil | “administration of reslizumab (Cinquil ), a humanized monoclonal antibody directed against IL-5” NCT01111305 ↗ |
| Known as | DCP 835 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107884 ↗ |
| Known as | SCH 55700 | “SCH 55700 is an antibody to interleukin 5-a hormone-like substance produced by white blood cells that plays a significant role in eosinophilia.” NCT00017862 ↗ |
| Action | Inhibit | “SCH 55700 is an antibody to interleukin 5-a hormone-like substance produced by white blood cells that plays a significant role in eosinophilia.” NCT00017862 ↗ |
| Modality | Monoclonal antibody | “humanized monoclonal anti-IL5 antibody” NCT00017862 ↗ |
| Route | Intravenous | “Following intravenous administration of a single 1 mg/kg dose” NCT00017862 ↗ |
| Target | IL5 | “a neutralizing antibody against IL-5” PMID 22206777 ↗ Dec 2011 |