Drugs / Reslizumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed asthma 2 milestones | |||||
| Filed | EU (EMA) | — | asthma | 2015-07-28 | “today announced that it has successfully filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for reslizumab.” tevapharm.com ↗ |
| Filed | US (FDA) | — | asthma | 2015-06-15 | “the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for reslizumab” tevapharm.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Cinqaero | — | 2016-08-15 | europa.eu ↗ |
| Approved | US (FDA) | CINQAIR | — | 2016-03-23 | fda.gov ↗ |
Trials 19
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| 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 · 1 met primary | ||||||
| Phase 2/3 | NCT02559791 | Oct 2015 → Apr 2017 | chronic asthma, chronic bronchitis | McMaster University | Completed | Met primary |
| Phase 2/3 | NCT00538434 | Mar 2008 → Oct 2009 | eosinophilic esophagitis | Ception Therapeutics | Completed | Mixed |
| Phase 310 trials · 1 met primary · 3 missed | ||||||
| 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 | Missed primary |
| Phase 3 | NCT02452190 | Sep 2015 → Dec 2017 | asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Missed primary |
| Phase 3 | NCT01508936 | Feb 2012 → Aug 2013 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Missed primary |
| Phase 3 | NCT01290887 | Jun 2011 → Jan 2015 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01287039 | Apr 2011 → Dec 2013 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Mixed |
| Phase 3 | NCT01285323 | Mar 2011 → Apr 2014 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Mixed |
| Phase 3 | NCT01270464 | Feb 2011 → Sep 2013 | T2-high asthma | Teva Branded Pharmaceutical Products R&D, Inc. | Completed | Met primary |
| 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 Stop: Enrollment |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT01111305 Comparator | Apr 2010 → Jan 2016 | loiasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 4 | NCT04710134 Comparator | Feb 2021 → Jan 2024 | asthma | McMaster University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2018-01-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Announces Top-Line Results from Phase III Studies of Subcutaneously Administered Reslizumab in Patients with Severe Eosinophilic Asthma tevapharm.com ↗
A Phase III claim-support study evaluating subcutaneously administered reslizumab in patients with oral corticosteroid (OCS)-dependent asthma did not meet its primary endpoint of reduction in daily OCS dose. |
| 2017-07-20 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory NICE Recommends CINQAERO® (reslizumab) for the Treatment of Severe Eosinophilic Asthma tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the National Institute for Health and Care Excellence (NICE) in England has recommended CINQAERO® (reslizumab) in its Final Appraisal Determination (FAD). |
| 2016-08-18 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory European Commission Grants Marketing Authorization for Teva’s CINQAERO® (reslizumab) tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the European Commission has granted marketing authorization for CINQAERO® (reslizumab) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. |
| 2016-07-25 | Teva Canada | Regulatory Teva Canada Innovation Announces Approval of CINQAIR™ by Health Canada tevacanada.com ↗ |
| 2016-06-24 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Receives CHMP Positive Opinion for CINQAERO® (reslizumab) tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (NYSE and TASE:TEVA) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending marketing authorization for CINQAERO® (reslizumab), a humanized interleukin 5 antagonist monoclonal antibody for add-on therapy in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus another medicinal product for maintenance treatment. |
| 2016-03-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Approval of CINQAIR® (reslizumab) Injection tevapharm.com ↗ |
| 2015-12-10 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory FDA Advisory Committee Recommends Approval of Teva’s Asthma Biologic Reslizumab tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the U.S. Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee recommended approval of reslizumab, a humanized anti-interleukin-5 (IL-5) IgG4K monoclonal antibody (mAb), in adult patients aged 18 years and older. |
| 2015-09-27 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva Presents New Reslizumab Data at European Respiratory Society (ERS) International Congress 2015 tevapharm.com ↗
New Analysis Shows Reslizumab Reduced Asthma Exacerbations by 75 percent in Patients with Late Onset Asthma and Elevated Blood Eosinophils |
| 2015-07-28 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces European Medicines Agency (EMA) Confirms Successful Validation of Reslizumab Marketing Authorization Application tevapharm.com ↗
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) today announced that it has successfully filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for reslizumab. |
| 2015-06-15 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces FDA Acceptance of the Biologics License Application for Reslizumab tevapharm.com ↗
The reslizumab BLA filing acceptance represents a significant milestone for Teva as we work toward serving a specific asthma patient population that is defined by elevated blood eosinophil levels and inadequately controlled symptoms despite standard of care therapy. |
| 2015-02-23 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) announced today that The Lancet Respiratory Medicine has published data from two replicate 52-week Phase III global studies on the company’s investigational anti-interleukin-5 (IL-5) monoclonal antibody, reslizumab. |
| 2014-09-08 | Teva Branded Pharmaceutical Products R&D, Inc. | Results 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 ↗
The data demonstrated that reslizumab treatment resulted in significant improvement in lung function and asthma control measures and showed a safety profile comparable to placebo. |
| 2014-09-02 | Teva Branded Pharmaceutical Products R&D, Inc. | Results Teva’s Reslizumab Delivers Clinically and Statistically Significant Reduction in Asthma Exacerbations in Two Pivotal Phase III Studies tevapharm.com ↗
In both trials, reslizumab treatment showed both clinically relevant and statistically significant reductions in the frequency of CAE compared to placebo (50% and 60% respectively, p <0.0001 for both). |
All press releases naming this drug 13 releases
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 NCT02947945 ↗ |
| 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 |