Daunorubicin clinical trials
Daunorubicin is named as an intervention in 64 current clinical trials in our Mexico, Israel, Canada, China, Australia, Germany, Italy, France, Netherlands, Austria, Czechia, Spain, Belgium, Switzerland, Norway, Sweden, Poland, USA, South Korea, Japan, Egypt, Portugal, UK, Taiwan, Ireland, Denmark, Turkey, Brazil and Singapore registers. 34 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is National Cancer Institute (NCI) (20). The most-studied condition is Acute Myeloid Leukemia. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Daunorubicin is approved
All regulators →Of the three regulators tracked here, the first to approve Daunorubicin was the US, on 19 Dec 1979.
- 2 EU orphan designations, most recently for treatment of acute myeloid leukaemia (11 Jan 2012, 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.
What health systems spend on Daunorubicin
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 Daunorubicin works
All drug targets →- DNA topoisomerase II alpha inhibitor InhibitorTarget: TOP2A DNA topoisomerase II alphaChEMBL only
- B-cell acute lymphoblastic leukemiaPhase 3
- Down syndromePhase 3
- T-cell acute lymphoblastic leukemiaPhase 3
- T-cell non-Hodgkin lymphomaPhase 3
- T-lymphoblastic lymphomaPhase 3
- Acute lymphoblastic leukemiaPhase 3
- Acute promyelocytic leukemiaPhase 3
- Chronic myeloid leukemiaPhase 3
- Early T cell progenitor acute lymphoblastic leukemiaPhase 3
- Lymphoblastic lymphomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL178, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7063, 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 Daunorubicin
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Daunorubicin. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Liposomal cytarabine–daunorubicin for untreated acute myeloid leukaemia NICE TA552 | Recommended | 19 Dec 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 Daunorubicin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 1 product on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- 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 Daunorubicin
- ATC code
- L01DB02
- ChEMBL
- CHEMBL178
- DrugBank
- DB00694
- PubChem CID
- 30323
- CAS number
- 20830-81-3
- FDA UNII
- ZS7284E0ZP
- Wikidata
- Q411659
- Wikipedia
- Daunorubicin
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 Daunorubicin
64 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.
Daunorubicin in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Daunorubicin. 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 |
|---|---|---|---|---|
|
Prospective evaluation of response to treatment by analysis of measurable residual disease in younger adult patients (18-60 years) with acute myeloid leukemia (AML). The Backbone InterGroup (BIG)-2 umbrella trial from the Acute Leukemia French Intergroup (ALFA, FILO) - BIG-2
2026-525759-96-00 · CTIS ↗ · Hemic and Lymphatic Diseases
|
Phase 3 | Authorised | Centre Hospitalier Universitaire De Toulouse | France |
|
A Phase 1/2, Multicenter, First-in-Human, Dose Escalation and Expansion Study Evaluating CHM-029, as Monotherapy and in Combination with Standard Therapies in Participants with Relapsed or Refractory, or Newly Diagnosed Acute Myeloid Leukemia (AML) with NPM1 Mutations, KMT2A or NUP98 Rearrangements
2026-526409-14-00 · Neoplasms
|
Phase 1 | Authorised | Charm Therapeutics Limited | France, Germany, Spain + 2 more |
Daunorubicin 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)
1 single-substance product containing Daunorubicin on the HPRA medicines list.
- Cerubidin 20 mg Powder for Concentrate for Solution for InfusionSanofi-Aventis Ireland Limited T/A SANOFI · PA0540/096/001 · Marketed
Supply shortages
No entry for Daunorubicin in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Daunorubicin
101 conditionsAll 101 conditions
| Condition (as registered) | Trials |
|---|---|
| Acute Myeloid Leukemia | 15 |
| Acute Lymphoblastic Leukemia | 5 |
| B Acute Lymphoblastic Leukemia | 5 |
| Acute Myeloid Leukemia (AML) | 3 |
| AML | 3 |
| Childhood Leukemia, Acute Lymphoblastic | 3 |
| Down Syndrome | 3 |
| Lisaftoclax | 2 |
| Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm | 2 |
| Acute Myeloid Leukemia Post Cytotoxic Therapy | 2 |
| Acute Myeloid Leukemia, Myelodysplasia-Related | 2 |
| Mixed Phenotype Acute Leukemia | 2 |
| B Lymphoblastic Lymphoma | 2 |
| Breast Adenocarcinoma | 2 |
| Ganglioneuroblastoma | 2 |
| Neuroblastoma | 2 |
| Ann Arbor Stage III Diffuse Large B-Cell Lymphoma | 2 |
| Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma | 2 |
| Lymphoblastic Lymphoma, Childhood | 1 |
| Leukemia, Myeloid, Acute | 1 |
| Mixed Lineage Leukemia Gene Mutation | 1 |
| Refractory AML | 1 |
| AML With Mutated NPM1 | 1 |
| AML, Adult | 1 |
| Precursor Cell Lymphoblastic Leukemia-Lymphoma | 1 |
| ETP-ALL | 1 |
| Acute Leukemia of Ambiguous Lineage | 1 |
| AML (Acute Myelogenous Leukemia) | 1 |
| T Cell Acute Lymphoblastic Leukemia/Lymphoblastic Lymphoma | 1 |
| NPM1 Mutation | 1 |
| IDH1 Mutation | 1 |
| IDH2 Mutation | 1 |
| RUNX1-RUNX1T1 Fusion Protein Expression | 1 |
| Acute Lymphoblastic Leukemia ALL | 1 |
| B Cell Acute Lymphoblastic Leukemia (B-ALL) | 1 |
| Acute Lymphoblastic Leukemia (ALL) Philadelphia Chromosome-positive (Ph+) | 1 |
| FLT3-mutated Acute Myeloid Leukemia | 1 |
| Newly Diagnosed Acute Myeloid Leukemia (AML) | 1 |
| Untreated AML | 1 |
| AML Arising From Myelodysplastic Syndrome (MDS) | 1 |
| AML Arising From Antecedent Hematologic Disorder (AHD) | 1 |
| Acute Lymphoblastic Leukemia, Pediatric | 1 |
| Acute Myeloid Leukemia in Children | 1 |
| B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative | 1 |
| Adult T Acute Lymphoblastic Leukemia | 1 |
| Ann Arbor Stage II Adult Lymphoblastic Lymphoma | 1 |
| Ann Arbor Stage II Childhood Lymphoblastic Lymphoma | 1 |
| Ann Arbor Stage III Adult Lymphoblastic Lymphoma | 1 |
| Acute Lymphoid Leukemia | 1 |
| Minimal Residual Disease | 1 |
| Gene Abnormality | 1 |
| Chemotherapeutic Toxicity | 1 |
| Childhood Cancer | 1 |
| Leukemia, Lymphoid | 1 |
| Acute Lymphoblastic Lymphoma | 1 |
| T Acute Lymphoblastic Leukemia | 1 |
| Central Nervous System Leukemia | 1 |
| Myelodysplastic Syndrome | 1 |
| Myeloid Leukemia Associated With Down Syndrome | 1 |
| Core Binding Factor Acute Myeloid Leukemia | 1 |
| Estrogen Receptor Negative | 1 |
| HER2/Neu Negative | 1 |
| Progesterone Receptor Negative | 1 |
| Locally Advanced Pancreatic Ductal Adenocarcinoma | 1 |
| Metastatic Pancreatic Ductal Adenocarcinoma | 1 |
| Stage II Pancreatic Cancer AJCC v8 | 1 |
| Stage IIA Pancreatic Cancer AJCC v8 | 1 |
| Ganglioneuroblastoma, Nodular | 1 |
| Primary Mediastinal Large B-Cell Lymphoma | 1 |
| Adult T-Cell Leukemia/Lymphoma | 1 |
| Anaplastic Large Cell Lymphoma, ALK-Negative | 1 |
| Anaplastic Large Cell Lymphoma, ALK-Positive | 1 |
| Angioimmunoblastic T-Cell Lymphoma | 1 |
| Metastatic Ewing Sarcoma | 1 |
| Metastatic Malignant Neoplasm in the Bone | 1 |
| Metastatic Malignant Neoplasm in the Bone Marrow | 1 |
| Metastatic Malignant Neoplasm in the Lung | 1 |
| Localized Resectable Neuroblastoma | 1 |
| Localized Unresectable Neuroblastoma | 1 |
| Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8 | 1 |
| Ann Arbor Stage IIB Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IIIB Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IVA Hodgkin Lymphoma | 1 |
| Ann Arbor Stage IVB Hodgkin Lymphoma | 1 |
| Ann Arbor Stage III Hodgkin Lymphoma | 1 |
| Ann Arbor Stage III Lymphocyte-Depleted Classic Hodgkin Lymphoma | 1 |
| Ann Arbor Stage III Mixed Cellularity Classic Hodgkin Lymphoma | 1 |
| Ann Arbor Stage III Nodular Sclerosis Classic Hodgkin Lymphoma | 1 |
| Diffuse Large B-Cell Lymphoma | 1 |
| Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | 1 |
| Double-Expressor Lymphoma | 1 |
| EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified | 1 |
| Grade 1 Follicular Lymphoma | 1 |
| Grade 2 Follicular Lymphoma | 1 |
| Grade 3a Follicular Lymphoma | 1 |
| Recurrent Follicular Lymphoma | 1 |
| B Acute Lymphoblastic Leukemia With t(9;22)(q34.1;q11.2); BCR-ABL1 | 1 |
| Renal Pelvis and Ureter Urothelial Carcinoma | 1 |
| Ann Arbor Stage II Diffuse Large B-Cell Lymphoma | 1 |
| Ann Arbor Stage IIX (Bulky) Diffuse Large B-Cell Lymphoma | 1 |
| Diffuse Large B-Cell Lymphoma Activated B-Cell Type | 1 |
Sponsors
lead sponsor per trial+ 13 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 Daunorubicin trials
How many clinical trials are testing Daunorubicin?
64 current trials in our Mexico, Israel, Canada, China, Australia, Germany, Italy, France, Netherlands, Austria, Czechia, Spain, Belgium, Switzerland, Norway, Sweden, Poland, USA, South Korea, Japan, Egypt, Portugal, UK, Taiwan, Ireland, Denmark, Turkey, Brazil and Singapore registers name Daunorubicin (also registered as FI-6339) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Daunorubicin trials recruiting patients?
Yes. 34 of the 64 trials are recruiting: 12 with sites in Mexico, 9 with sites in Israel, 10 with sites in Canada, 14 with sites in China, 6 with sites in Australia, 5 with sites in Germany, 3 with sites in Italy, 3 with sites in France, 3 with sites in Netherlands, 3 with sites in Austria, 3 with sites in Czechia, 3 with sites in Spain, 3 with sites in Belgium, 3 with sites in Switzerland, 2 with sites in Norway, 2 with sites in Sweden, 2 with sites in Poland, 2 with sites in USA, 2 with sites in South Korea, 1 with sites in Japan, 1 with sites in Egypt, 2 with sites in Portugal, 1 with sites in UK, 1 with sites in Taiwan, 1 with sites in Ireland, 1 with sites in Denmark 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 Daunorubicin clinical trials?
National Cancer Institute (NCI) (20), Institute of Hematology & Blood Diseases Hospital, China (10), Children's Oncology Group (6) and First Affiliated Hospital of Zhejiang University (3), among 28 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Daunorubicin 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 Daunorubicin licensed in Ireland?
Yes. The HPRA medicines list includes 1 single-substance product containing Daunorubicin, for example Cerubidin 20 mg Powder for Concentrate for Solution for Infusion (Sanofi-Aventis Ireland Limited T/A SANOFI). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Daunorubicin shortage?
Not in the lists we track: Daunorubicin 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 Daunorubicin 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 Daunorubicin 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 Daunorubicin (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.