DrugBiological
Nirsevimab clinical trials
Also written MEDI8897 and Beyfortus.
- studies test it
- 15
- open now
- 3
- in phase 3
- 6
- first study started
- 2014
Keep track of what changes. Save the nirsevimab studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
15 studies that test it; most in 2025 (3)
| Year | Studies |
|---|---|
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 3 |
| 2026 | 1 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 3
- Phase 2
- 3
- Phase 3
- 6
- Phase 4
- 4
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 11 · Other 4
AstraZeneca (6) · MedImmune LLC (3) · Sanofi (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Sanofi Pasteur, a Sanofi Company (1) · PENTA Foundation (1) · Menzies School of Health Research (1) · Duke University (1)
Often tested with
Tested in the same studies.
Studies
Open first, then newest update. How each study uses nirsevimab is read from its arms, and is right about nine times in ten.
Testing it · 15
- THRIVE - Trial of Passive Humoral RSV Immunity for Value and EffectivenessRecruitingPhase 4Menzies School of Health ResearchNCT07578298Written as Nirsevimab (RSV-specific monoclonal antibody)
- Safety of RSV Preventive Monoclonal AntibodyRecruitingPhase 4Duke UniversityNCT07158814Written as Respiratory Syncytial Virus (RSV) Preventive Monoclonal Antibody
- 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.Not yet recruitingPhase 3PENTA FoundationNCT07041190Written as Nirsevimab
- Evaluate the Safety and Efficacy of Nirsevimab in Healthy Preterm and Term Infants in ChinaCompletedPhase 3AstraZenecaNCT05110261Written as Nirsevimab
- The Immunology and Safety of Maternal RSV Vaccination (ABRYSVO), Infant Nirsevimab (BEYFORTUS) Immunization, or Both ProductsCompletedPhase 4National Institute of Allergy and Infectious Diseases (NIAID)NCT06551506Written as Beyfortus
- A Study to Assess Safety, Pharmacokinetics Anti-Drug Antibody and Anti-RSV Antibody After 2 Doses of NirsevimabCompletedPhase 3AstraZenecaNCT06042049Written as Nirsevimab
- Study of Monoclonal Antibody Nirsevimab Against Respiratory Syncytial Virus (RSV) in Participants up to 24 Months of Age in IndiaActive, not recruitingPhase 4SanofiNCT07109297Written as Nirsevimab
- 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 LifeCompletedPhase 3Sanofi Pasteur, a Sanofi CompanyNCT05437510Written as Nirsevimab
- 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)CompletedPhase 3AstraZenecaNCT03979313Written as MEDI8897
- Evaluate the Safety and Tolerability, for Nirsevimab in Immunocompromised ChildrenCompletedPhase 2AstraZenecaNCT04484935Written as Nirsevimab
- Evaluate the Pharmacokinetics, Safety, and Tolerability of Nirsevimab in Healthy Chinese AdultsCompletedPhase 1AstraZenecaNCT04840849Written as nirsevimab
- 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 ChildrenCompletedPhase 2/3AstraZenecaNCT03959488Written as MEDI8897
- A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.CompletedPhase 2MedImmune LLCNCT02878330Written as MEDI8897
- 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 InfantsCompletedPhase 1MedImmune LLCNCT02290340Written as MEDI8897 10 mg
- A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy AdultsCompletedPhase 1MedImmune LLCNCT02114268Written as MEDI8897 Intravenous
Given in every arm · 1 — nirsevimab is usual care beside what is tested
As the comparator · 2 — what is tested is compared with nirsevimab
- Phase Ib/IIa Clinical Trial of SIBP-A16 Injection in Premature Infants and Full-term InfantsNot yet recruitingPhase 1/2Shanghai Institute Of Biological ProductsNCT07363837Written as Nirsevimab
- A Clinical Trial of SIBP-A16 Injection in Healthy AdultsRecruitingEarly Phase 1Shanghai Institute Of Biological ProductsNCT07106918Written as Nirsevimab
Codes
What other systems call nirsevimab · ClinicalTrials.gg INT001398
- MeSH (NLM) C000709769nirsevimabConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) VRN8S9CW5VNIRSEVIMABConfirmed FDA, NLM, Wikidata
- Wikidata Q111535760nirsevimabConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C170224NirsevimabOne source FDA
- DrugBank DB16258One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000709769 | nirsevimab | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | VRN8S9CW5V | NIRSEVIMAB | Confirmed FDA, NLM, Wikidata |
| Wikidata | Q111535760 | nirsevimab | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C170224 | Nirsevimab | One source FDA |
| DrugBank | DB16258 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.