Drugs / Palivizumab
Palivizumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | SYNAGIS | — | 2003-09-15 – 2012-04-04 | fda.gov ↗ |
| Approved | EU (EMA) | Synagis | — | 1999-08-13 | europa.eu ↗ |
| Approved | US (FDA) | SYNAGIS | — | 1998-06-19 | fda.gov ↗ |
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 22 trials | ||||||
| Phase 2 | NCT00316264 | Apr 2006 → Feb 2007 | lung disorder, respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00240929 | Sep 2002 → Apr 2003 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT01006629 | Nov 2009 → Apr 2010 | bronchopulmonary dysplasia, congenital heart disease, respiratory syncytial virus infectious disease | Abbott | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT02968173 | Nov 2016 → Jul 2017 | respiratory syncytial virus infectious disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01466062 | Aug 2011 → Apr 2012 | respiratory syncytial virus infectious disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT00014391 | Feb 1999 → Oct 2001 | cancer | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06851806 | Dec 2025 → Feb 2027 expected | respiratory syncytial virus infectious disease | AstraZeneca | Active not recruiting | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT05121246 Comparator | Jun 2022 → Mar 2023 | — | mAbxience Research S.L. | Completed | Missed primary |
| Phase 1 | NCT04540627 Comparator | Jul → Oct 2020 | — | mAbxience Research S.L. | Completed | No outcome recorded |
| Phase 1/2 | NCT00113490 Comparator | May 2005 → Feb 2006 | — | MedImmune LLC | Completed | No outcome recorded |
| Phase 2 | NCT00538785 Comparator | Oct 2005 → Jun 2008 | congenital heart disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 2/3 | NCT03959488 Comparator | Jul 2019 → May 2021 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT04938830 Comparator | Nov 2021 → Apr 2025 | respiratory syncytial virus infectious disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 3 | NCT02442427 Comparator | Sep 2014 → Feb 2018 | respiratory syncytial virus bronchiolitis | Hamad Medical Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00129766 Comparator | Nov 2004 → May 2006 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | Met primary |
| Phase 4 | NCT00233064 Comparator | Oct 2005 → Oct 2007 | lung disorder | MedImmune LLC | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | palivizumab | “Children will be followed for adverse events through 30 days after each injection of study drug and will have blood collected for determination of palivizumab concentrations in serum.” NCT00240929 ↗ |
| Known as | MEDI-493 | “A Phase II Randomized, Double-Blind, Two-Period Cross-Over Study to Evaluate the Pharmacokinetics, Safety and Tolerability of a Liquid Formulation of Palizvizumab (MEDI-493,...” NCT00240929 ↗1“Study to Assess the Immune Reactivity of the Liquid and Lyophilized Formulations of Palivizumab (MEDI-493, Synagis)” NCT00233064 ↗ |
| Known as | Synagis | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05121246 ↗ |
| Known as | Synagis abbosynagis | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201586 ↗ |
| Modality | Monoclonal antibody | “A Humanized Respiratory Syncytial Virus Monoclonal Antibody” NCT00240929 ↗ |
| Route | Intravenous | “palivizumab IV 2 hours before ribavirin administration on day 1” NCT00014391 ↗ |