Nirsevimab

Summary

Nirsevimab (CHEMBL4297575) is an approved antibody (ATC J06BD08); indicated across 2 conditions including respiratory syncytial virus infectious disease.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Antibody
• ATC class: J06BD08
• Indications: 2 conditions
• Clinical trials: 23

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4297575
Name	Nirsevimab
Type	Antibody
Max phase	4
ATC	J06BD08

Also known as: Beyfortus, MED-18897, Medi8897, MEDI8897, Nirsevimab, Nirsevimab-alip, NIRSEVIMAB

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
respiratory syncytial virus infectious disease	4	MONDO:0001577	EFO:1001413

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 23.

Phase distribution

Phase	Trials
Not specified	7
PHASE3	6
PHASE1	3
PHASE4	2
PHASE2	2
PHASE2/PHASE3	1
PHASE1/PHASE2	1
EARLY_PHASE1	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07109297	PHASE4	ACTIVE_NOT_RECRUITING	Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in India
NCT06551506	PHASE4	COMPLETED	The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both Products
NCT07041190	PHASE3	NOT_YET_RECRUITING	Pregnancy and Infant PrEparedness pLatform IN Europe, RSV-International Adaptive Platform Trial to Evaluate Two Approved Prevention Options to Prevent Respiratory Syncytial Virus in Infants: Maternal Vaccine to Women in Pregnancy and Monoclonal Antibody to the Infants, Given Alone or in Combination.
NCT07232706	PHASE3	RECRUITING	Prevention of RSV Infection in Infants by Administering Nirsevimab to Infants, With or Without Maternal RSV Vaccination
NCT03959488	PHASE2/PHASE3	COMPLETED	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
NCT03979313	PHASE3	COMPLETED	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)
NCT05110261	PHASE3	COMPLETED	Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in China
NCT05437510	PHASE3	COMPLETED	Study of a Single Intramuscular Dose of Nirsevimab in the Prevention of Hospitalizations Due to Respiratory Syncytial Virus (RSV) Infection in Healthy Term and Preterm Infants During the First Year of Life
NCT06042049	PHASE3	COMPLETED	A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of Nirsevimab
NCT07363837	PHASE1/PHASE2	NOT_YET_RECRUITING	Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term Infants
NCT02878330	PHASE2	COMPLETED	A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
NCT04484935	PHASE2	COMPLETED	Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised Children
NCT02114268	PHASE1	COMPLETED	A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults
NCT02290340	PHASE1	COMPLETED	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
NCT04840849	PHASE1	COMPLETED	Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese Adults
NCT07106918	EARLY_PHASE1	RECRUITING	A Clinical Trial of SIBP-A16 Injection in Healthy Adults
NCT06172660	Not specified	RECRUITING	Real-World Effectiveness of Perinatal RSV Immunoprophylaxis
NCT06180993	Not specified	RECRUITING	Evaluation of the Effectiveness and Impact of Nirsevimab Administered as Routine Immunization
NCT06511687	Not specified	RECRUITING	Effectiveness And Impact Of Nirsevimab In Chile (NIRSE-CL)
NCT06856967	Not specified	RECRUITING	Evaluation of the Effect of Nirsevimab on Hospitalizations Due to RSV Infection in Infants Under One Year of Age.
NCT07200206	Not specified	RECRUITING	A Post-marketing Surveillance Study of Beyfortus (Nirsevimab) in Republic of Korea
NCT06325332	Not specified	COMPLETED	BEYFORTUS™ (Nirsevimab) Effectiveness Against Medically-Attended RSV Events in Infants (BEAR Study)
NCT07382219	Not specified	COMPLETED	Real-World Effectiveness of Nirsevimab Against RSV-Related and All-Cause Respiratory Tract Infections in Chinese Infants

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).