Palivizumab

Generic Name
Palivizumab
Brand Names
Synagis
Drug Type
Biotech
Chemical Formula
-
CAS Number
188039-54-5
Unique Ingredient Identifier
DQ448MW7KS
Background

Humanized monoclonal antibody (IgG1k) produced by recombinant DNA technology, directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Synagis is a composite of human (95%) and murine (5%) antibody sequences. The human heavy chain sequence was derived from the constant domains of human IgG1 and the variable framework regions of the VH genes Cor (1) and Cess (2). The human lightchain sequence was derived from the constant domain of Ck and the variable framework regions of the VL gene K104 withJk-4. Palivizumab is expressed from a stable murine (mouse) myeloma cell line (NS0). Palivizumab is composed of to heavy chains (50.6 kDa each) and two light chains (27.6 kDa each), contains 1-2% carbohydrate by weight and has a molecular weight of 147.7 kDa +/- 1 kDa (MALDI-TOF)

Indication

For prophylaxis of respiratory diseases casued by respiratory syncytial virus.

Associated Conditions
Severe Respiratory Syncytial Virus Infection
Associated Therapies
-

Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

Phase 3
Active, not recruiting
Conditions
Interventions
First Posted Date
2021-06-24
Last Posted Date
2024-12-16
Lead Sponsor
Merck Sharp & Dohme LLC
Target Recruit Count
1000
Registration Number
NCT04938830
Locations
🇺🇸

DHR Health Institute for Research and Development ( Site 0029), Edinburg, Texas, United States

🇺🇸

NYU Langone Hospital - Long Island-Pediatrics ( Site 0028), Mineola, New York, United States

🇺🇸

Miller Children's & Women's Hospital Long Beach ( Site 0001), Long Beach, California, United States

and more 143 locations

Exploratory Study to Estimate the Prophylactic Efficacy of Palivizumab in Healthy Adult Participants Inoculated With RSV

First Posted Date
2020-09-07
Last Posted Date
2021-10-04
Lead Sponsor
mAbxience Research S.L.
Target Recruit Count
56
Registration Number
NCT04540627
Locations
🇬🇧

hVIVO Services Limited, London, United Kingdom

A Study to Evaluate the Safety of MEDI8897 for the Prevention of Medically Attended Respiratory Syncytial Virus(RSV) Lower Respiratory Track Infection (LRTI) in High-risk Children

First Posted Date
2019-05-22
Last Posted Date
2023-09-21
Lead Sponsor
AstraZeneca
Target Recruit Count
925
Registration Number
NCT03959488
Locations
🇬🇧

Research Site, Nottingham, United Kingdom

"Palivizumab Therapy for RSV-bronchiolitis"

First Posted Date
2015-05-13
Last Posted Date
2018-02-27
Lead Sponsor
Hamad Medical Corporation
Target Recruit Count
420
Registration Number
NCT02442427
Locations
🇶🇦

Hamad Medical Corporation, Doha, Qatar

Clinical Study of Palivizumab in Japanese Newborns, Infants and Young Children at the Age of 24 Months or Less With Immunocompromised Medical Conditions

Phase 3
Completed
Conditions
Interventions
First Posted Date
2011-11-06
Last Posted Date
2013-06-17
Lead Sponsor
AbbVie (prior sponsor, Abbott)
Target Recruit Count
28
Registration Number
NCT01466062
Locations
🇯🇵

Site Reference ID/Investigator# 56847, Hyogo, Japan

🇯🇵

Site Reference ID/Investigator# 56843, Yokohama, Japan

🇯🇵

Site Reference ID/Investigator# 56842, Tokyo, Japan

and more 3 locations
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