Drugs / Zanamivir
Zanamivir
also known as
[14C]-ZANAMIVIR · Dectova · GG-167 · GR 121167X · GR121167 · IVZ · RELENZA · ZANAMIVIR TFA
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Dectova | — | 2019-04-26 | europa.eu ↗ |
| Label expansions (2) | US (FDA) | RELENZA | — | 2000-04-26 – 2006-03-29 | fda.gov ↗ |
| Approved | US (FDA) | RELENZA | — | 1999-07-26 | fda.gov ↗ |
Trials 17
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 16 trials | ||||||
| Phase 1 | NCT02377401 | Apr → Jun 2015 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01353729 | May → Aug 2011 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT01428479 | Jan → Apr 2011 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00989404 | Oct → Dec 2009 | swine influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00921726 | Jul → Oct 2009 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT00540501 | Oct 2007 | — | GlaxoSmithKline | Withdrawn | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT04597437 | Mar 2024 → Sep 2026 overdue | dengue disease | George Washington University | Recruiting | No outcome recorded |
| Phase 2 | NCT05648448 | Feb 2023 → Jan 2027 expected | influenza | University of Oxford | Recruiting | No outcome recorded |
| Phase 2 | NCT04494412 | Nov 2022 → Jan 2026 | arthropathy, influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT04867707 | Jul 2021 → Oct 2024 | type 2 diabetes mellitus | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 2 | NCT01014988 | Nov 2009 → Feb 2015 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT00830323 | Jan → Aug 2009 | influenza | Hospices Civils de Lyon | Terminated | No outcome recorded |
| Phase 35 trials · 2 missed | ||||||
| Phase 3 | NCT01527110 | Jan 2012 → Mar 2013 | influenza | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01459081 | Oct 2011 → Dec 2012 | influenza | Jiangsu Simcere Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT01231620 | Jan 2011 → Mar 2015 | influenza | GlaxoSmithKline | Completed | Missed primary |
| Phase 3 | NCT00979667 | Oct 2009 → Aug 2010 | influenza, upper respiratory tract disorder | Chinese University of Hong Kong | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00784784 | Nov 2008 → May 2009 | influenza | Mount Sinai Hospital, Canada | Completed | Missed primary |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT00867139 Comparator | Mar → Aug 2009 | influenza | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00799760 Comparator | Dec 2008 → Nov 2009 | viral gastritis | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded |
| Phase 4 | NCT00980109 Comparator | Sep 2009 → Sep 2010 | influenza | University of Oxford | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2019-03-01 | GlaxoSmithKline | Regulatory GSK receives a positive CHMP opinion for intravenous zanamivir for the treatment of complicated influenza gsk.com ↗
GSK today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for intravenous zanamivir for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when the patient’s influenza virus is known or suspected to be resistant to anti-influenza agents other than zanamivir, and/or other anti-viral agents for treatment of influenza, including inhaled zanamivir (Relenza), are not suitable for the individual patient. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-01 | GlaxoSmithKline | GSK receives a positive CHMP opinion for intravenous zanamivir for the treatment of complicated influenza gsk.com ↗ |
| 2011-01-19 | GlaxoSmithKline | GlaxoSmithKline commences Phase III study of intravenous zanamivir for hospitalised patients with influenza gsk.com ↗ |
| 2009-01-28 | GlaxoSmithKline | The UK Government signs influenza pandemic contract with GlaxoSmithKline for Relenza® gsk.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | zanamivir | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01014988 ↗ |
| Known as | [14C]-ZANAMIVIR | ChEMBL registry synonym — accepted as the source's own label CHEMBL222813 ↗ |
| Known as | Dectova | ChEMBL registry synonym — accepted as the source's own label CHEMBL222813 ↗ |
| Known as | GG-167 | ChEMBL registry synonym — accepted as the source's own label CHEMBL222813 ↗ |
| Known as | GR 121167X | ChEMBL registry synonym — accepted as the source's own label CHEMBL222813 ↗ |
| Known as | GR121167 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01428479 ↗ |
| Known as | IVZ | “Therefore the safety and efficacy profile of intravenous zanamivir (IVZ) was examined in Japanese patients with severe influenza.” PMID 25470818 ↗ Dec 2014 |
| Known as | RELENZA | “Zanamivir (RELENZA®)” NCT05648448 ↗ |
| Known as | ZANAMIVIR TFA | ChEMBL registry synonym — accepted as the source's own label CHEMBL222813 ↗ |
| Action | Inhibit | “Although zanamivir and oseltamivir are both issued from the same class ,a combination of these two neuraminidase inhibitors” NCT00799760 ↗ |
| Modality | Small molecule | — CHEMBL222813 ↗ |
| Route | Intravenous | “Zanamivir IV continuous infusion 50mg/hour for 16 hours (total dose of 800mg)” NCT00540501 ↗ |