Nirsevimab clinical trials
Nirsevimab is named as an intervention in 7 current clinical trials in our China, India, France, Italy, South Korea and Australia registers. 5 are recruiting patients now. The most common phase is Phase 4. The sponsor with the most trials is Sanofi (2). The most-studied condition is Respiratory Syncytial Virus (RSV).
Where Nirsevimab is approved
All regulators →Of the three regulators tracked here, the first to approve Nirsevimab was the EU, on 31 Oct 2022. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
How Nirsevimab works
All drug targets →- Fusion glycoprotein F0 inhibitor InhibitorChEMBL only
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4297575, CC BY-SA 3.0. The Guide to Pharmacology has no record of this medicine, so its targets rest on ChEMBL alone. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Nirsevimab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: BeyfortusEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Nirsevimab
- ChEMBL
- CHEMBL4297575
- DrugBank
- DB16258
- CAS number
- 1989556-22-0
- FDA UNII
- VRN8S9CW5V
- Wikidata
- Q111535760
- Wikipedia
- Nirsevimab
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Nirsevimab
7 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Nirsevimab across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
2 single-substance products containing Nirsevimab on the HPRA medicines list.
- Beyfortus 100 mg solution for injection in pre-filled syringeSanofi Winthrop Industrie · EU/1/22/1689/004-006
- Beyfortus 50 mg solution for injection in pre-filled syringeSanofi Winthrop Industrie · EU/1/22/1689/001-003
Supply shortages
No entry for Nirsevimab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Nirsevimab
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Sanofi | 2 |
| Shanghai Institute Of Biological Products | 2 |
| Centre Hospitalier Annecy Genevois | 1 |
| Meyer Children's Hospital IRCCS | 1 |
| Menzies School of Health Research | 1 |
By country register
| Register | Trials | Recruiting |
|---|---|---|
| Clinical trials in China | 2 | 1 |
| Clinical trials in India | 1 | 0 |
| Clinical trials in France | 1 | 1 |
| Clinical trials in Italy | 1 | 1 |
| Clinical trials in South Korea | 1 | 1 |
| Clinical trials in Australia | 1 | 1 |
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Nirsevimab trials
How many clinical trials are testing Nirsevimab?
7 current trials in our China, India, France, Italy, South Korea and Australia registers name Nirsevimab as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Nirsevimab trials recruiting patients?
Yes. 5 of the 7 trials are recruiting: 1 with sites in China, 1 with sites in France, 1 with sites in Italy, 1 with sites in South Korea and 1 with sites in Australia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Nirsevimab clinical trials?
Sanofi (2), Shanghai Institute Of Biological Products (2), Centre Hospitalier Annecy Genevois (1) and Meyer Children's Hospital IRCCS (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Nirsevimab licensed in Ireland?
Yes. The HPRA medicines list includes 2 single-substance products containing Nirsevimab, for example Beyfortus 100 mg solution for injection in pre-filled syringe (Sanofi Winthrop Industrie). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Nirsevimab shortage?
Not in the lists we track: Nirsevimab has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Nirsevimab works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Nirsevimab works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Nirsevimab (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.