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motavizumab (MEDI-524)
motavizumab (MEDI-524) is a Monoclonal antibody Biologic drug developed by MedImmune LLC. It is currently in Phase 3 development for Prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease. Also known as: MEDI-524, motavizumab, Rezield.
Motavizumab is a monoclonal antibody that targets the respiratory syncytial virus (RSV) F-protein.
Motavizumab, also known as MEDI-524, is an antibody that inhibits the fusion glycoprotein F0. It is used to prevent Respiratory Syncytial Virus Infections.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | motavizumab (MEDI-524) |
|---|---|
| Also known as | MEDI-524, motavizumab, Rezield |
| Sponsor | MedImmune LLC |
| Drug class | Monoclonal antibody |
| Target | RSV F-protein |
| Modality | Biologic |
| Therapeutic area | Respiratory |
| Phase | Phase 3 |
Mechanism of action
It works by binding to the F-protein on the surface of RSV, preventing the virus from entering host cells and causing infection. This mechanism of action is specific to RSV and does not affect other viruses or pathogens.
Approved indications
- Prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease
Common side effects
- Injection site reaction
- Headache
- Nausea
Key clinical trials
- MEDI-524 (Motavizumab) for the Prevention of Respiratory Sycytial Virus (RSV) Disease Among Native American Indian Infants in the Southwestern United States (PHASE3)
- Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection (PHASE1)
- A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness (NA)
- A Study to Evaluate a Single Intramuscular Dose of Motavizumab to Treat Children With Respiratory Syncytial Virus (RSV) Illness (PHASE2)
- Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children (PHASE3)
- A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children (PHASE1, PHASE2)
- Study of Motavizumab (MEDI-524) and Palivizumab Administered Sequentially in the Same Respiratory Syncytial Virus (RSV) Season (PHASE2)
- A Phase 3 Trial of the Effect of Motavizumab Prophylaxis on Reduction of Serious Early Childhood Wheezing in Infants (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- motavizumab (MEDI-524) CI brief — competitive landscape report
- motavizumab (MEDI-524) updates RSS · CI watch RSS
- MedImmune LLC portfolio CI
Frequently asked questions about motavizumab (MEDI-524)
What is motavizumab (MEDI-524)?
How does motavizumab (MEDI-524) work?
What is motavizumab (MEDI-524) used for?
Who makes motavizumab (MEDI-524)?
Is motavizumab (MEDI-524) also known as anything else?
What drug class is motavizumab (MEDI-524) in?
What development phase is motavizumab (MEDI-524) in?
What are the side effects of motavizumab (MEDI-524)?
What does motavizumab (MEDI-524) target?
Related
- Drug class: All Monoclonal antibody drugs
- Target: All drugs targeting RSV F-protein
- Manufacturer: MedImmune LLC — full pipeline
- Therapeutic area: All drugs in Respiratory
- Indication: Drugs for Prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease
- Also known as: MEDI-524, motavizumab, Rezield
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing