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Nirsevimab

Phase 3

Respiratory Syncytial Virus Infections | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Apr 16, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment33
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06042049A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of NirsevimabPHASE3 COMPLETED 33Jul 27, 2023Jul 24, 2025Apr 16, 20269 Japan
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), Adverse Events of Special Interest (AESIs), and New-onset Chronic Diseases (NOCDs)
From the first dose administration (Day 1) through 360 days post 2nd dose, study Day 511

An AE was development of any untoward medical occurrence in a participant or clinical study participant administered medicinal product and which did not necessarily have causal relationship with this treatment. TEAEs were AEs whose onset occurred after receiving nirsevimab through 360 days post second dose. An SAE was any AE that resulted in death, was immediately life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly or birth defect or was an important medical event that might jeopardize the participant or may require medical treatment to prevent 1 of the outcomes listed above. AESIs were based on assessment by investigators following the administration of nirsevimab. An NOCD was a newly diagnosed medical condition of chronic, ongoing nature post administration of study drug.

Secondary Endpoints
Serum Concentrations of Nirsevimab
Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose
Number of Participants With Anti-drug Antibody (ADA) Response to Nirsevimab
Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose
Serum Anti-respiratory Syncytial Virus (RSV) Neutralizing Antibody (nAb) Levels
Pre-dose Day 1, pre-dose Day 151, Day 181 post first-dose, Day 301 post first-dose, and Day 511 post first-dose
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION
Treatment Arms
ArmTypeDescription
MEDI8897EXPERIMENTALAnti-RSV monoclonal antibody
Interventions
NameTypeDescription
NirsevimabDRUGParticipants in the first year of life will receive the 1st dose of nirsevimab as a single, fixed intramuscular (IM) dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg. A 2nd fixed IM dose of 50 mg if body weight is \<5 kg or 100 mg if body weight is ≥5 kg will be administered 5 to 6 months following the 1st dose.
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Eligibility Criteria
Age Range0 Years — 1 Year
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: 1. Written informed consent and any locally required authorization obtained from the participant's parent(s)/legally authorized representative(s) before performing any protocol-related procedures, including screening evaluations 2. Japanese infants of ≤12 months of age eligible ...

Countries:Japan
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06042049TRIAL_REMOVED: changed
LOWMay 24, 2026NCT06042049studyFirstPostDate: changed