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MEDI8897
MEDI8897 is a monoclonal antibody that provides extended half-life neutralization of respiratory syncytial virus (RSV) through engineered Fc region modifications.
MEDI8897 is a monoclonal antibody that provides extended half-life neutralization of respiratory syncytial virus (RSV) through engineered Fc region modifications. Used for Prevention of respiratory syncytial virus (RSV) disease in infants born during RSV season, Prevention of RSV disease in older adults.
At a glance
| Generic name | MEDI8897 |
|---|---|
| Sponsor | MedImmune LLC |
| Drug class | RSV monoclonal antibody |
| Target | RSV fusion (F) protein |
| Modality | Small molecule |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
MEDI8897 binds to the RSV fusion (F) protein and prevents viral entry into host cells. The antibody incorporates MedImmune's proprietary half-life extension technology to provide prolonged protection against RSV infection, particularly in vulnerable populations such as infants and elderly patients.
Approved indications
- Prevention of respiratory syncytial virus (RSV) disease in infants born during RSV season
- Prevention of RSV disease in older adults
Common side effects
- Injection site reactions
- Upper respiratory tract infection
- Fever
Key clinical trials
- Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China (PHASE3)
- A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab (PHASE3)
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY) (PHASE3)
- Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children (PHASE2)
- Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults (PHASE1)
- 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 (PHASE2, PHASE3)
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants. (PHASE2)
- A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897, a Monoclonal Antibody With an Extended Half-life Against Respiratory Syncytial Virus, in Healthy Preterm Infants (PHASE1)
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:
- MEDI8897 CI brief — competitive landscape report
- MEDI8897 updates RSS · CI watch RSS
- MedImmune LLC portfolio CI