Nintedanib clinical trials
Nintedanib is named as an intervention in 5 current clinical trials in our Switzerland, France, UK, USA, Germany, Spain, Italy, Belgium, Canada, Japan, Poland and Australia registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (1). The most-studied condition is Systemic Sclerosis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Nintedanib is approved
All regulators →Of the three regulators tracked here, the first to approve Nintedanib was the EU, on 21 Nov 2014. It is approved in 2 of the 3 regulators tracked here.
- 2 EU orphan designations, most recently for treatment of systemic sclerosis (29 Aug 2016, withdrawn)
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 Nintedanib
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 Nintedanib works
All drug targets →- Platelet-derived growth factor receptor inhibitor InhibitorTarget: Platelet-derived growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Vascular endothelial growth factor receptor inhibitor InhibitorTarget: Vascular endothelial growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- Fibroblast growth factor receptor inhibitor InhibitorTarget: Fibroblast growth factor receptor✓ In ChEMBL and the Guide to Pharmacology
- AdenocarcinomaPhase 3
- AdenomyosisPhase 3
- Bronchiolitis obliterans syndromePhase 3
- Limited sclerodermaPhase 3
- Malignant epithelial tumor of ovaryPhase 3
- MesotheliomaPhase 3
- Ovarian cancerPhase 3
- Ovarian carcinomaPhase 3
- Malignant pleural mesotheliomaPhase 2/3
- Acute myeloid leukemiaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL502835, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5936, 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 Nintedanib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 5 technology appraisals of Nintedanib. 5 are current, and 4 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Nintedanib for treating fibrosing interstitial lung disease in people 6 to 17 years (terminated appraisal) NICE TA1111 | Terminated (no company submission) | 19 Nov 2025 | Current |
| Nintedanib for treating idiopathic pulmonary fibrosis when forced vital capacity is above 80% predicted NICE TA864 | Recommended | 1 Feb 2023 | Current |
| Nintedanib for treating progressive fibrosing interstitial lung diseases NICE TA747 | Recommended | 17 Nov 2021 | Current |
| Nintedanib for treating idiopathic pulmonary fibrosis NICE TA379 | Optimised | 27 Jan 2016 | Current |
| Nintedanib for previously treated locally advanced, metastatic, or locally recurrent non‑small‑cell lung cancer NICE TA347 | Recommended | 22 Jul 2015 | 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 Nintedanib
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: Ofev, Vargatef, Nintedanib Accord (generic), Nintedanib Viatris (generic)EMA 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 Nintedanib
- ATC code
- L01XE31
- ChEMBL
- CHEMBL502835
- DrugBank
- DB09079
- PubChem CID
- 135423438
- CAS number
- 656247-17-5
- FDA UNII
- G6HRD2P839
- Wikidata
- Q15149723
- Wikipedia
- Nintedanib
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 Nintedanib
5 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.
Nintedanib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Nintedanib. 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 |
|---|---|---|---|---|
|
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)
2025-524337-11-00 · Immune System Diseases
|
Phase 3 | Authorised | Celgene Corp | Spain, Germany, France + 2 more |
Nintedanib 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 Nintedanib on the HPRA medicines list.
- Ofev 100 mg Soft capsuleBoehringer Ingelheim International GmbH · EU/1/14/979/001-002
- Ofev 150 mg Soft capsuleBoehringer Ingelheim International GmbH · EU/1/14/979/003-004
- Vargatef 100 mg soft capsulesBoehringer Ingelheim International GmbH · EU/1/14/954/001-003
- Vargatef 150 mg soft capsulesBoehringer Ingelheim International GmbH · EU/1/14/954/004
Supply shortages
No entry for Nintedanib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Nintedanib
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | 1 |
| Dr. Romain Lazor | 1 |
| National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland | 1 |
| Boehringer Ingelheim | 1 |
| Endeavor Biomedicines, Inc | 1 |
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 Nintedanib trials
How many clinical trials are testing Nintedanib?
5 current trials in our Switzerland, France, UK, USA, Germany, Spain, Italy, Belgium, Canada, Japan, Poland and Australia registers name Nintedanib as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Nintedanib trials recruiting patients?
Yes. 3 of the 5 trials are recruiting: 1 with sites in Switzerland, 1 with sites in France, 1 with sites in Poland 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 Nintedanib clinical trials?
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company (1), Dr. Romain Lazor (1), National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland (1) and Boehringer Ingelheim (1), among 5 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Nintedanib licensed in Ireland?
Yes. The HPRA medicines list includes 4 single-substance products containing Nintedanib, for example Ofev 100 mg Soft capsule (Boehringer Ingelheim International GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Nintedanib shortage?
Not in the lists we track: Nintedanib 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 Nintedanib 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 Nintedanib 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 Nintedanib (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 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.