Drugs / Nirsevimab
Nirsevimab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Beyfortus | — | 2022-10-31 | europa.eu ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04840849 | Jun → Nov 2021 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02290340 | Jan 2015 → Sep 2016 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 1 | NCT02114268 | Apr 2014 → Jun 2015 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT04484935 | Aug 2020 → Feb 2023 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02878330 | Nov 2016 → Jul 2018 | respiratory syncytial virus infectious disease | MedImmune LLC | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT03959488 | Jul 2019 → May 2021 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT07232706 | May 2026 → May 2029 expected | respiratory syncytial virus infectious disease | Centre Hospitalier Annecy Genevois | Recruiting | No outcome recorded |
| Phase 3 | NCT07041190 | Sep 2025 → Nov 2028 expected | respiratory syncytial virus infectious disease | PENTA Foundation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06042049 | Jul 2023 → Jul 2025 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT05437510 | Aug 2022 → Mar 2024 | respiratory syncytial virus infectious disease | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT05110261 | Nov 2021 → Nov 2025 | viral respiratory tract infection | AstraZeneca | Completed | No outcome recorded |
| Phase 3 | NCT03979313 | Jul 2019 → Mar 2021 | respiratory syncytial virus infectious disease | AstraZeneca | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT07578298 | May 2026 → Jul 2030 expected | respiratory syncytial virus infectious disease | Menzies School of Health Research | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07158814 | Oct 2025 → Feb 2027 expected | — | Duke University | Recruiting | No outcome recorded |
| Phase 4 | NCT07109297 | Jul 2025 → Jun 2026 overdue | respiratory syncytial virus infectious disease | Sanofi | Active not recruiting | No outcome recorded |
| Phase 4 | NCT06551506 | Sep 2024 → May 2026 | respiratory syncytial virus infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07106918 Comparator | Aug 2025 → Apr 2027 expected | respiratory syncytial virus infectious disease | Shanghai Institute Of Biological Products | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07363837 Comparator | Jan 2026 → Mar 2027 expected | respiratory syncytial virus infectious disease | Shanghai Institute Of Biological Products | Not yet recruiting | No outcome recorded |
Press releases naming this drug 23 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-02-16 | Sanofi | Press Release: Beyfortus study published in The Lancet Infectious Diseases shows benefit for infants beyond first RSV season sanofi.com ↗ |
| 2025-06-09 | Sanofi | Press Release: Sanofi accelerates global shipping of Beyfortus to prepare healthcare providers months ahead of 2025-2026 RSV season sanofi.com ↗ |
| 2025-05-29 | Sanofi | Press Release: Beyfortus public health advantage bolstered by first real-world comparison of infant vs maternal RSV immunization programs sanofi.com ↗ |
| 2024-10-09 | Sanofi | Press Release: New Beyfortus data featured at IDWeek reinforce real-world effectiveness against RSV disease and hospitalization in infants sanofi.com ↗ |
| 2024-05-02 | Sanofi | Press Release: Beyfortus real-world evidence published in The Lancet shows 82% reduction in infant RSV hospitalizations sanofi.com ↗ |
| 2024-03-27 | AstraZeneca | Beyfortus approved in Japan for the prevention of RSV disease in infants astrazeneca.com ↗ |
| 2024-01-02 | AstraZeneca | Beyfortus approved in China for the prevention of RSV disease in infants astrazeneca.com ↗ |
| 2023-10-27 | Sanofi | Press Release: Specialty Care growth, strong launch uptake of Beyfortus® and ALTUVIIIO® drive solid Q3 results sanofi.com ↗ |
| 2023-08-03 | Sanofi | Press Release: U.S. CDC Advisory Committee unanimously recommends routine use of Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease sanofi.com ↗ |
| 2023-07-17 | Sanofi | FDA approves Beyfortus™ (nirsevimab-alip) to protect infants against RSV disease sanofi.com ↗ |
| 2023-06-08 | Sanofi | Press Release: FDA Advisory Committee unanimously recommends nirsevimab as first immunization against RSV disease for all infants sanofi.com ↗ |
| 2023-05-12 | Sanofi | Press Release: Nirsevimab delivers 83% reduction in RSV infant hospitalizations in a real-world clinical trial setting sanofi.com ↗ |
| 2023-04-11 | Sanofi | Press Release: Nirsevimab: Sanofi, AstraZeneca and Sobi simplify contractual agreements sanofi.com ↗ |
| 2023-02-21 | Sanofi | Media Update: Pediatric research at ReSViNET 2023 underscores Beyfortus’ potential to prevent RSV disease in infants sanofi.com ↗ |
| 2023-01-05 | Sanofi | Press Release: FDA accepts nirsevimab application as first protective option against RSV disease for all infants sanofi.com ↗ |
| 2022-11-04 | Sanofi | Press Release: European Commission grants first approval worldwide of Beyfortus® (nirsevimab) for prevention of RSV disease in infants sanofi.com ↗ |
| 2022-09-16 | Sanofi | Press Release: CHMP recommends approval of Beyfortus® (nirsevimab) for prevention of RSV disease in infants sanofi.com ↗ |
| 2022-05-11 | Sanofi | Press Release: New nirsevimab data analyses reinforce efficacy against RSV sanofi.com ↗ |
| 2022-03-03 | Sanofi | Nirsevimab Shows 74.5% Reduction in RSV Infections in Phase 3 Trial sanofi.com ↗ |
| 2022-02-17 | Sanofi | Nirsevimab EMA regulatory submission accepted under accelerated assessment for RSV protection in all infants sanofi.com ↗ |
| 2021-06-28 | Sanofi | Press Release: Nirsevimab shows positive topline results in RSV Phase 2/3 MEDLEY trial sanofi.com ↗ |
| 2021-04-26 | Sanofi | Nirsevimab demonstrated protection against respiratory syncytial virus disease in healthy infants in Phase 3 trial sanofi.com ↗ |
| 2020-07-30 | Sanofi | Positive Phase 2b Clinical Trial: Nirsevimab reduces lower respiratory tract infections by 70 percent sanofi.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nirsevimab | “nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca) administered to infants at birth or at the start of their first RSV season” NCT06551506 ↗12“The purpose of this study is to evaluate the Safety and Efficacy of Nirsevimab, in Healthy Preterm and Term Infants in China” NCT05110261 ↗ “Nirsevimab” NCT07158814 ↗ |
| Known as | BEYFORTUS | “nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca” NCT06551506 ↗ |
| Known as | MED-18897 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297575 ↗ |
| Known as | MEDI8897 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02114268 ↗ |
| Known as | Nirsevimab (MEDI8897) | “Nirsevimab (MEDI8897)” NCT04484935 ↗ |
| Known as | nirsevimab-alip | “nirsevimab-alip [henceforth referred to as nirsevimab], BEYFORTUS, AstraZeneca” NCT06551506 ↗ |
| Modality | Monoclonal antibody | “MEDI8897 is a recombinant human RSV monoclonal antibody” PMID 27956428 ↗ Feb 2017 |
| Route | Intramuscular | “Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts.” NCT02114268 ↗ |
| Route | Intravenous | “Investigational product was delivered intravenously (IV) to 3 cohorts and intramuscularly (IM) to 2 cohorts.” NCT02114268 ↗ |