palivizumab
Trade name: Synagis
mAbapproved
Approved
Jun 19, 1998
Palivizumab, sold under the brand name Synagis, is a monoclonal antibody produced by recombinant DNA technology used to prevent severe disease caused by respiratory syncytial virus (RSV) infections. It is recommended for infants at high-risk for RSV due to conditions such as prematurity or other medical problems including heart or lung diseases. — Wikipedia
Clinical trial activity
19 trials · 19 clinical orgs · 3 marketing orgs
Phase 1
3
Phase 2
11
Phase 3
8
Phase 4
3
Earliest trial started Feb 1, 1999 (NCT00014391)
Timeline
1990s
- Jun 19, 1998
MedImmune — Earliest FDA Approval
- Jun 19, 1998
Swedish Orphan — Marketing Organization
- Jun 19, 1998
MedImmune — Marketing Organization
- Jun 19, 1998
MedImmune — NDA Organization
- Jun 19, 1998
Swedish Orphan Biovitrum — NDA Secondary Org
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
Indications
Studied for
- Bronchopulmonary Dysplasia · Phase 2/Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Fever · Phase 4
- Healthy Volunteers · Phase 1
- Heart Defects, Congenital · Phase 2/Phase 3
- Immunotherapy · Phase 2
- Infant, Premature · Phase 2
- Infant, Premature, Diseases · Phase 2
- Lung Diseases · Phase 4
- Neoplasms · Phase 3
- Premature Birth · Phase 2/Phase 3
- Radiation Oncology · Phase 2
- Respiratory Syncytial Virus Infections · Phase 3
Mechanism of action
- Programmed cell death protein 1ANTAGONIST
PD1
- RSV F-proteinANTAGONIST
RSV F-protein antagonist
- Fusion glycoprotein F0INHIBITOR
F inhibitor
Pathogen target
Approval history
- approvedJun 19, 1998
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaPalivizumab ↗
- NCATSDQ448MW7KS ↗
- ChEMBLCHEMBL1201586 ↗
Also known as
- anti-rsv
- medi-493
- medi-493
- medi-493
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- palivizumab
- synagis
- synagis
- synagis
- synagis abbosynagis
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07158814 | Phase 4 | Oct 2, 2025 | Centers for Disease Control and Prevention (CDC), Columbia University, Duke University, Emory University, Kaiser Permanente, University of Cincinnati |
| NCT06851806 | N/A | Apr 1, 2025 | AstraZeneca |
| NCT06738160 | Phase 2 | Dec 20, 2024 | Fudan University |
| NCT05444673 | Phase 4 | Jun 1, 2022 | Sun Yat-Sen University |
| NCT05121246 | Phase 1 | Jan 31, 2022 | Insud Pharma |
| NCT04938830 | Phase 3 | Nov 30, 2021 | Merck |
| NCT04540627 | Phase 1 | Jul 6, 2020 | hVIVO Services Limited, Insud Pharma |
| NCT03959488 | Phase 2/Phase 3 (Phase 3) | Jul 26, 2019 | AstraZeneca |
| NCT02968173 | Phase 3 | Nov 9, 2016 | AbbVie |
| NCT02442427 | Phase 3 | Sep 1, 2014 | Cornell University, Hamad Medical Corporation |
| NCT01466062 | Phase 3 | Aug 1, 2011 | AbbVie |
| NCT01006629 | Phase 2/Phase 3 (Phase 3) | Nov 1, 2009 | Abbott |
| NCT00316264 | Phase 2 | Apr 1, 2006 | MedImmune |
| NCT00233064 | Phase 4 | Oct 1, 2005 | MedImmune |
| NCT00538785 | Phase 2 | Oct 1, 2005 | MedImmune |
| NCT00113490 | Phase 1/Phase 2 (Phase 2) | May 1, 2005 | MedImmune |
| NCT00129766 | Phase 3 | Nov 1, 2004 | MedImmune |
| NCT00240929 | Phase 2 | Sep 1, 2002 | MedImmune |
| NCT00014391 | Phase 3 | Feb 1, 1999 | National Cancer Institute (NCI), University of Washington |
Showing 19 of 19 trials
Page 1 / 1
Organizations
Research & Development (19)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| MedImmune | For profit | 6 | 6 | 3 | 2002 |
| AbbVie | For profit | 2 | 2 | 1 | 2011 |
| AstraZeneca | For profit | 2 | 2 | 2 | 2019 |
| Insud Pharma | For profit | 2 | 2 | 1 | 2020 |
| Abbott | For profit | 1 | 1 | 1 | 2009 |
| Centers for Disease Control and Prevention (CDC) | Government | 1 | 0 | 1 | 2025 |
| Columbia University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Cornell University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Duke University | Academic/Hospital | 1 | 1 | 1 | 2025 |
| Emory University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Fudan University | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Hamad Medical Corporation | For profit | 1 | 1 | 1 | 2014 |
| hVIVO Services Limited | For profit | 1 | 0 | 1 | 2020 |
| Kaiser Permanente | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Merck | For profit | 1 | 1 | 1 | 2021 |
| National Cancer Institute (NCI) | Government | 1 | 0 | 1 | 1999 |
| Sun Yat-Sen University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Cincinnati | Academic/Hospital | 1 | 0 | 1 | 2025 |
| University of Washington | Academic/Hospital | 1 | 1 | 1 | 1999 |
19 organizations
Page 1 / 1
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| MedImmune | For profit | MKTG | Jun 19, 1998 |
| MedImmune | For profit | NDA | Jun 19, 1998 |
| Swedish Orphan | For profit | MKTG | Jun 19, 1998 |
| Swedish Orphan Biovitrum | For profit | NDA2 | Jun 19, 1998 |