Ruxolitinib clinical trials
Ruxolitinib is named as an intervention in 70 current clinical trials in our USA, France, Spain, Italy, Germany, China, Canada, Poland, UK, Belgium, Israel, Australia, South Korea, Japan, Netherlands, Turkey, Sweden, Denmark, Austria, Taiwan, Czechia, Switzerland, Portugal, Brazil, Mexico, Norway, Egypt, India and Ireland registers. 35 are recruiting patients now. The most common phase is Phase 2. The sponsor with the most trials is Incyte Corporation (15). The most-studied condition is Myelofibrosis. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials, 1 with a site in Ireland.
Where Ruxolitinib is approved
All regulators →Of the three regulators tracked here, the first to approve Ruxolitinib was the US, on 16 Nov 2011. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of polycythaemia vera (19 Feb 2014, withdrawn)
- 1 EU safety letter (DHPC), latest: quality defect for Opzelura, 24 Apr 2025
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.
Ruxolitinib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Ruxolitinib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 34 listed patents; the last listed expires 5 May 2041 (US 11602536).
- Exclusivity PED: Pediatric exclusivity, until 22 Mar 2029.
- Exclusivity ODE-373: Orphan drug exclusivity: treatment of chronic graft-versus-host disease (cgvhd) after failure of one or two lines of systemic therapy in ad…, until 22 Sep 2028.
- Exclusivity ODE*: FDA has not recognized orphan-drug exclusivity (ode) for this drug, but it contains the same active moiety or moieties as another drug(s) t…, until 22 Sep 2028.
- Exclusivity NPP: New patient population, until 18 Sep 2028.
- Exclusivity PED: Pediatric exclusivity, until 24 Nov 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Ruxolitinib
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 Ruxolitinib works
All drug targets →- Tyrosine-protein kinase JAK1 inhibitor InhibitorTarget: JAK1 Janus kinase 1✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK2 inhibitor InhibitorTarget: JAK2 Janus kinase 2✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase JAK3 inhibitor InhibitorTarget: JAK3 Janus kinase 3✓ In ChEMBL and the Guide to Pharmacology
- Tyrosine-protein kinase TYK2 inhibitor InhibitorTarget: TYK2 tyrosine kinase 2✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- Acute graft versus host diseasePhase 3
- Acute respiratory distress syndromePhase 3
- Exocrine pancreatic carcinomaPhase 3
- Hand eczemaPhase 3
- Hemophagocytic syndromePhase 3
- Hidradenitis suppurativaPhase 3
- Macrophage activation syndromePhase 3
- Malignant pancreatic neoplasmPhase 3
- Pancreatic adenocarcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1789941, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5688, 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 Ruxolitinib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 10 technology appraisals of Ruxolitinib. 8 are current, and 4 of these recommend it for at least some patients. 2 older appraisals were replaced or withdrawn.
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 Ruxolitinib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 10 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- 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 Ruxolitinib
- ATC code
- L01XE18
- ChEMBL
- CHEMBL1789941
- DrugBank
- DB08877
- PubChem CID
- 25126798
- CAS number
- 941678-49-5
- FDA UNII
- 82S8X8XX8H
- Wikidata
- Q7383611
- Wikipedia
- Ruxolitinib
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 Ruxolitinib
70 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.
Ruxolitinib in the EU trials register (CTIS)
3 trials · 1 in IrelandAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ruxolitinib. 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, Double-Blind, Randomized Trial Evaluating the Efficacy and Safety of Elritercept (TAK‑226) Compared to Placebo in Participants With Myelofibrosis and Anemia on Concurrent Ruxolitinib Therapy
2026-525660-17-00 · Hemic and Lymphatic Diseases
|
Phase 3 | Authorised | Takeda Development Center Americas Inc | Ireland + 13 more |
|
A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive
2025-523555-66-00 · CTIS ↗ · Neoplasms
|
Phase 3 | Ongoing | Novartis Pharma AG | Belgium, Germany, Austria + 6 more |
|
Framework for Optimizing, Refining, and Unifying Management of HSCT in Pediatric ALL.
2025-522052-13-00 · CTIS ↗ · Hemic and Lymphatic Diseases
|
Phase 3 | Ongoing | Ospedale Pediatrico Bambino Gesu | Germany, Denmark, Finland + 14 more |
Ruxolitinib 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)
10 single-substance products containing Ruxolitinib on the HPRA medicines list.
- Jakavi 10 mg tabletsNovartis Europharm Limited · EU/1/12/773/013-016
- Jakavi 15 mg tabletsNovartis Europharm Limited · EU/1/12/773/007-009
- Jakavi 20 mg tabletsNovartis Europharm Limited · EU/EU/1/12/773/010-012
- Jakavi 5 mg tabletsNovartis Europharm Limited · EU/1/12/773/004-006
- Jakavi 5mg/ml Oral solutionNovartis Europharm Limited · EU/1/12/773/017
Supply shortages
No entry for Ruxolitinib in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Ruxolitinib
87 conditionsAll 87 conditions
| Condition (as registered) | Trials |
|---|---|
| Myelofibrosis | 12 |
| Polycythemia Vera | 5 |
| Primary Myelofibrosis | 4 |
| Atopic Dermatitis | 3 |
| Hidradenitis Suppurativa | 3 |
| Vitiligo | 3 |
| Myeloproliferative Neoplasm | 2 |
| NonSegmental Vitiligo | 2 |
| Essential Thrombocythemia | 2 |
| Myeloproliferative Neoplasms | 2 |
| Post-PV MF | 2 |
| Post-ET Myelofibrosis | 2 |
| Neoplasms | 2 |
| Myelofibrosis (MF) | 2 |
| Multiple Myeloma | 2 |
| Pregnancy Related | 2 |
| Primary Myelofibrosis (PMF) | 2 |
| Acute Myeloid Leukemia | 2 |
| Acute Lymphoblastic Leukemia, in Relapse | 1 |
| Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent | 1 |
| Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent | 1 |
| Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory | 1 |
| Myelodysplastic Syndrome | 1 |
| Myelodysplastic/Myeloproliferative Neoplasm Overlap Syndrome | 1 |
| Chronic Graft-versus-host-disease | 1 |
| Solid Tumor, Adult | 1 |
| Non-Hodgkin Lymphoma, Adult | 1 |
| NSCLC | 1 |
| B-Cell Malignancies | 1 |
| Post-polycythemia Vera Myelofibrosis | 1 |
| Post-essential Thrombocythemia Myelofibrosis | 1 |
| Moderate Thrombocytopenia | 1 |
| Mild Thrombocytopenia | 1 |
| Post-polycythemia Vera Myelofibrosis (PPV-MF) | 1 |
| Post-essential Thrombocythemia Myelofibrosis (PET-MF) | 1 |
| Myeloproliferative Neoplasms (MPNs) | 1 |
| Multiple Myeloma in Relapse | 1 |
| Multiple Myeloma, Refractory | 1 |
| Graft-versus-host Disease (GVHD) | 1 |
| Pancreatic Cancer | 1 |
| Colorectal Cancer (CRC) | 1 |
| Breast Cancer | 1 |
| Lung Cancer | 1 |
| Graft Versus Host Disease | 1 |
| AML, Adult | 1 |
| MF,PMF,PPV-MF,PET-MF | 1 |
| Steroid-refractory Acute Graft Versus Host Disease | 1 |
| Graft vs. Host Disease | 1 |
| Chronic Graft vs. Host Disease | 1 |
| Corticosteroid-refractory Chronic Graft vs. Host Disease | 1 |
| Peripheral Blood Stem Cell Transplantation | 1 |
| GVHD,Acute | 1 |
| Stem Cell Transplant Complications | 1 |
| Alopecia Areata | 1 |
| Janus Kinase Inhibitors | 1 |
| Graft vs Host Disease | 1 |
| Carcinoma, Squamous Cell of Head and Neck HNSCC | 1 |
| Polycythemia Vera (PV) | 1 |
| Essential Thrombocythemia (ET) | 1 |
| Advanced Solid Tumors | 1 |
| Acute Myeloid Leukaemia (AML) | 1 |
| High-risk Myelodysplastic Syndrome | 1 |
| Haemophagocytic Lymphohistiocytosis | 1 |
| Inclusion Body Myositis, Sporadic | 1 |
| Renal Carcinoma Metastatic | 1 |
| Pancreatic Adenocarcinoma Metastatic | 1 |
| Pancreatic Adenocarcinoma | 1 |
| Metastatic Colorectal Carcinoma (mCRC) | 1 |
| Immune-related Vitiligo-like-Depigmentation | 1 |
| Exanthema | 1 |
| Lichenoid Skin Rashes Under Anti-PD1 Tumor Therapy | 1 |
| High-Risk Cancer | 1 |
| Bone Marrow Cancer | 1 |
| Discoid Lupus Erythematosus | 1 |
| cGVHD | 1 |
| Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive | 1 |
| Post-polycythemia Vera Myelofibrosis (Post-PV MF) | 1 |
| Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) | 1 |
| GVHD - Graft-Versus-Host Disease | 1 |
| Haematopoietic Stem Cell Transplantation | 1 |
| Acute Lymphoblastic Leukemia | 1 |
| Acute Lymphoblastic Lymphoma | 1 |
| Acute Myeloid Leukemia in Remission | 1 |
| Allogeneic Stem Cell Transplantation | 1 |
| Nonsegmental Vitiligo | 1 |
| Non-Segmental Vitiligo (NSV) | 1 |
| MF | 1 |
Sponsors
lead sponsor per trial+ 24 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 Ruxolitinib trials
How many clinical trials are testing Ruxolitinib?
70 current trials in our USA, France, Spain, Italy, Germany, China, Canada, Poland, UK, Belgium, Israel, Australia, South Korea, Japan, Netherlands, Turkey, Sweden, Denmark, Austria, Taiwan, Czechia, Switzerland, Portugal, Brazil, Mexico, Norway, Egypt, India and Ireland registers name Ruxolitinib (also registered as INCB018424 Phosphate) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Ruxolitinib trials recruiting patients?
Yes. 35 of the 70 trials are recruiting: 17 with sites in USA, 11 with sites in France, 9 with sites in Spain, 9 with sites in Italy, 8 with sites in Germany, 12 with sites in China, 7 with sites in Canada, 5 with sites in Poland, 6 with sites in UK, 6 with sites in Belgium, 5 with sites in Israel, 5 with sites in Australia, 5 with sites in South Korea, 3 with sites in Japan, 4 with sites in Netherlands, 1 with sites in Turkey, 1 with sites in Sweden, 3 with sites in Denmark, 4 with sites in Austria, 2 with sites in Taiwan, 3 with sites in Czechia, 1 with sites in Switzerland, 2 with sites in Portugal, 2 with sites in Brazil, 1 with sites in Mexico, 1 with sites in Norway, 1 with sites in Egypt, 1 with sites in India and 1 with sites in Ireland. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ruxolitinib clinical trials?
Incyte Corporation (15), Novartis Pharmaceuticals (6), AbbVie (3) and Oncotherapeutics (3), among 39 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Ruxolitinib clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov), and 1 trial in the EU register (CTIS) list a site in Ireland. Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Ruxolitinib licensed in Ireland?
Yes. The HPRA medicines list includes 10 single-substance products containing Ruxolitinib, for example Jakavi 10 mg tablets (Novartis Europharm Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ruxolitinib shortage?
Not in the lists we track: Ruxolitinib 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 Ruxolitinib 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 Ruxolitinib 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 Ruxolitinib (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.