Pelabresib clinical trials
Pelabresib is named as an intervention in 7 current clinical trials in our Italy, UK, France, Spain, USA, Netherlands, Belgium, China, Germany, Poland, Austria, Czechia, Turkey, Canada, South Korea, Taiwan, Australia, Japan, Israel, India, Switzerland and Brazil registers. 5 are recruiting patients now. The most common phase is Phase 1. The lead sponsor is Novartis Pharmaceuticals. The most-studied condition is Advanced Malignancies. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Pelabresib is approved
All regulators →- 1 EU orphan designation, most recently for treatment of myelofibrosis (17 Feb 2025, positive)
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 Pelabresib works
All drug targets →- Bromodomain and extra-terminal motif (BET) inhibitor InhibitorTarget: Bromodomain and extra-terminal motif (BET)✓ In ChEMBL and the Guide to Pharmacology
- Hematopoietic and lymphoid cell neoplasmPhase 3
- MyelofibrosisPhase 3
- Malignant peripheral nerve sheath tumorPhase 2
- Acute leukemiaPhase 1/2
- Acute myeloid leukemia by FAB classificationPhase 1/2
- Essential thrombocythemiaPhase 1/2
- Myelodysplastic syndromePhase 1/2
- Myelodysplastic/myeloproliferative neoplasmPhase 1/2
- Myeloproliferative disorderPhase 1/2
- LymphomaPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL4303404, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9120, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Pelabresib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- 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 Pelabresib
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.
Pelabresib in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Pelabresib. 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, 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 |
Conditions studied with Pelabresib
14 conditionsAll 14 conditions
| Condition (as registered) | Trials |
|---|---|
| Advanced Malignancies | 2 |
| Primary Myelofibrosis (PMF) | 2 |
| Advanced Malignancies and Hepatic Impairment | 1 |
| Healthy Participants | 1 |
| Myelofibrosis | 1 |
| Primary Myelofibrosis | 1 |
| Post-polycythemia Vera Myelofibrosis | 1 |
| Post-essential Thrombocythemia Myelofibrosis | 1 |
| Hematologic Malignancy | 1 |
| Solid Tumor | 1 |
| Post-polycythemia Vera Myelofibrosis (PPV-MF) | 1 |
| Post-essential Thrombocythemia Myelofibrosis (PET-MF) | 1 |
| Post-polycythemia Vera Myelofibrosis (Post-PV MF) | 1 |
| Post-essential Thrombocythemia Myelofibrosis (Post-ET MF) | 1 |
Sponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 7 |
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 Pelabresib trials
How many clinical trials are testing Pelabresib?
7 current trials in our Italy, UK, France, Spain, USA, Netherlands, Belgium, China, Germany, Poland, Austria, Czechia, Turkey, Canada, South Korea, Taiwan, Australia, Japan, Israel, India, Switzerland and Brazil registers name Pelabresib (also registered as DAK539) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Pelabresib trials recruiting patients?
Yes. 5 of the 7 trials are recruiting: 4 with sites in Italy, 3 with sites in UK, 3 with sites in France, 3 with sites in Spain, 2 with sites in USA, 2 with sites in Netherlands, 2 with sites in Belgium, 1 with sites in China, 1 with sites in Germany, 1 with sites in Poland, 1 with sites in Austria, 1 with sites in Czechia, 1 with sites in Turkey, 1 with sites in Canada, 1 with sites in South Korea, 1 with sites in Taiwan, 1 with sites in Australia, 1 with sites in Japan, 1 with sites in India, 1 with sites in Switzerland and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pelabresib clinical trials?
The lead sponsor is Novartis Pharmaceuticals. The number in brackets is how many trials each organisation leads.
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 Pelabresib 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 Pelabresib 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 Pelabresib (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.