Dupilumab clinical trials
Dupilumab is named as an intervention in 54 current clinical trials in our USA, Canada, China, Germany, Japan, Italy, France, Spain, Taiwan, Netherlands, South Korea, UK, Belgium, Brazil, Mexico, Poland, Austria, Israel, Denmark, Australia, Singapore, Turkey, Switzerland, Portugal, Czechia, Ireland, India, Sweden and Norway registers. 26 are recruiting patients now. The most common phase is Observational. The sponsor with the most trials is Sanofi (17). The most-studied condition is Atopic Dermatitis. The EU clinical trials register (CTIS) separately lists 4 authorised or ongoing trials.
Where Dupilumab is approved
All regulators →Of the three regulators tracked here, the first to approve Dupilumab was the US, on 28 Mar 2017. 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.
What health systems spend on Dupilumab
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Dupilumab works
All drug targets →- Interleukin-4 receptor subunit alpha antagonist AntagonistTarget: IL4R interleukin 4 receptor✓ In ChEMBL and the Guide to Pharmacology
- PruritusPhase 3
- Airway hyperresponsivenessPhase 3
- Chronic idiopathic urticariaPhase 3
- Chronic obstructive pulmonary diseasePhase 3
- Chronic rhinosinusitis with nasal polypsPhase 3
- Eosinophilic esophagitisPhase 3
- Nasal cavity polypPhase 3
- NeurodermatitisPhase 3
- Prurigo nodularisPhase 3
- Netherton syndromePhase 2/3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108675, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7574, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Dupilumab
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 7 technology appraisals of Dupilumab. 7 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Dupilumab for maintenance treatment of uncontrolled chronic obstructive pulmonary disease with raised blood eosinophils NICE TA1142 | Optimised | 26 Mar 2026 | Current |
| Dupilumab for treating severe chronic rhinosinusitis with nasal polyps NICE TA1134 | Optimised | 18 Feb 2026 | Current |
| Dupilumab for treating moderate to severe prurigo nodularis NICE TA955 | Not recommended | 13 Mar 2024 | Current |
| Dupilumab for treating eosinophilic oesophagitis in people 12 years and over (terminated appraisal) NICE TA938 | Terminated (no company submission) | 7 Dec 2023 | Current |
| Dupilumab for treating severe asthma with type 2 inflammation NICE TA751 | Optimised | 8 Dec 2021 | Current |
| Dupilumab for treating chronic rhinosinusitis with nasal polyps (terminated appraisal) NICE TA648 | Terminated (no company submission) | 9 Sep 2020 | Current |
| Dupilumab for treating moderate to severe atopic dermatitis NICE TA534 | Optimised | 1 Aug 2018 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Dupilumab
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 4 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: DupixentEMA 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.
Trials by status
Trials by phase
Clinical trials of Dupilumab
54 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.
Dupilumab in the EU trials register (CTIS)
4 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Dupilumab. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
Optimization of Dupilumab Maintenance Dosing in Eosinophilic Esophagitis: A
Phase IV, Randomized, Controlled, Single-Blind, Non-Inferiority Study
2026-526348-11-01 · Digestive System Diseases
|
Phase 4 | Authorised | Amsterdam UMC Stichting | Netherlands |
|
A randomized, double blind, placebo-controlled study comparing the efficacy of dupilumab to standard of care (SOC) treatment following hospitalization for a COPD exacerbation
2025-524392-23-00 · Respiratory Tract Diseases
|
Phase 4 | Authorised | Regeneron Pharmaceuticals Inc | Belgium, Italy, Spain |
|
BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)
2025-524741-28-00 · CTIS ↗ · Respiratory Tract Diseases
|
Phase 4 | Authorised | Amsterdam UMC Stichting | Netherlands |
|
Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting
2025-524495-39-00 · CTIS ↗ · Otorhinolaryngologic Diseases
|
Phase 4 | Authorised | Medical University Of Vienna | Austria |
Dupilumab 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)
4 single-substance products containing Dupilumab on the HPRA medicines list.
- Dupixent 200 mg solution for injection in pre-filled penSanofi Winthrop Industrie · EU/1/17/1229/023-025
- Dupixent 200 mg solution for injection in pre-filled syringeSanofi Winthrop Industrie · EU/1/17/1229/009-0016
- Dupixent 300 mg solution for injection in pre-filled penSanofi Winthrop Industrie · EU/1/17/1229/026-028
- Dupixent 300 mg solution for injection in pre-filled syringeSanofi Winthrop Industrie · EU/1/17/1229/001-008
Supply shortages
No entry for Dupilumab in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Dupilumab
44 conditionsAll 44 conditions
| Condition (as registered) | Trials |
|---|---|
| Atopic Dermatitis | 12 |
| Asthma | 4 |
| Chronic Rhinosinusitis With Nasal Polyps | 4 |
| Dermatitis Atopic | 2 |
| Prurigo Nodularis | 2 |
| Chronic Rhinosinusitis With Nasal Polyposis | 2 |
| Chronic Obstructive Pulmonary Disease (COPD) | 2 |
| Dermatitis, Atopic | 2 |
| Eosinophilic Esophagitis (EoE) | 2 |
| Chronic Obstructive Pulmonary Disease | 1 |
| Wheezing | 1 |
| Pruritus | 1 |
| Chronic Spontaneous Urticaria (CSU) | 1 |
| COPD (Chronic Obstructive Pulmonary Disease) | 1 |
| Eosinophilic Gastritis (EoG) | 1 |
| Eosinophilic Duodenitis (EoD) | 1 |
| Eosinophilic Gastrointestinal Disease (EGID) | 1 |
| Eosinophilic Gastroenteritis | 1 |
| Food Allergy | 1 |
| Eosinophilic Oesophagitis | 1 |
| Colitis Ulcerative | 1 |
| Asthma in Children | 1 |
| Healthy Participants | 1 |
| Biosimilarity | 1 |
| Healthy Volunteers | 1 |
| Eosinophilic Esophagitis | 1 |
| Psoriasis | 1 |
| Atopic Dermatitis Eczema | 1 |
| Prurigo Nodularis (PN) | 1 |
| Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) | 1 |
| Chronic Rhinosinusitis (CRS) | 1 |
| Pathophysiology | 1 |
| Asthma; Eosinophilic | 1 |
| Eosinophilia | 1 |
| Chronic Rhinosinusitis Without Nasal Polyps | 1 |
| Asthma Control | 1 |
| Non-Small Cell Lung Cancer | 1 |
| Immunotherapy | 1 |
| Neoadjuvant Therapy | 1 |
| Nephrotic Syndrome in Children | 1 |
| Nephrotic Syndrome Steroid-Dependent | 1 |
| Atopic Dermatitis (AD) | 1 |
| Nummular Eczema | 1 |
| Nasal Polyps | 1 |
Sponsors
lead sponsor per trial+ 10 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Dupilumab trials
How many clinical trials are testing Dupilumab?
54 current trials in our USA, Canada, China, Germany, Japan, Italy, France, Spain, Taiwan, Netherlands, South Korea, UK, Belgium, Brazil, Mexico, Poland, Austria, Israel, Denmark, Australia, Singapore, Turkey, Switzerland, Portugal, Czechia, Ireland, India, Sweden and Norway registers name Dupilumab (also registered as REGN668) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Dupilumab trials recruiting patients?
Yes. 26 of the 54 trials are recruiting: 7 with sites in USA, 5 with sites in Canada, 6 with sites in China, 6 with sites in Germany, 4 with sites in Japan, 3 with sites in Italy, 2 with sites in France, 3 with sites in Spain, 3 with sites in Taiwan, 2 with sites in Netherlands, 2 with sites in South Korea, 1 with sites in UK, 3 with sites in Belgium, 1 with sites in Brazil, 2 with sites in Poland, 3 with sites in Austria, 2 with sites in Denmark, 1 with sites in Australia, 2 with sites in Singapore, 1 with sites in Switzerland and 1 with sites in Sweden. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Dupilumab clinical trials?
Sanofi (17), Regeneron Pharmaceuticals (8), Innovent Biologics (Suzhou) Co. Ltd (3) and AbbVie (2), among 25 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Dupilumab clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Dupilumab licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Dupilumab, for example Dupixent 200 mg solution for injection in pre-filled pen (Sanofi Winthrop Industrie). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Dupilumab shortage?
Not in the lists we track: Dupilumab 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 Dupilumab 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 Dupilumab 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 Dupilumab (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.