Ireland
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Priya Life Science Compound trial record
Compound · clinical trials

Chlorambucil clinical trials

Also listed in trial records as Leukeran
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 6 trials in our France, China, UK, USA, Spain, Italy, Belgium, Sweden, Poland, Canada, Israel, Taiwan, Germany, Brazil, Australia, Egypt, Netherlands, Denmark, Czechia, Turkey and Switzerland registers that name Chlorambucil as an intervention. Synced 9 Nov 2026
6Current trials
1Recruiting now
6Lead sponsors
21Country registers
At a glance

Chlorambucil is named as an intervention in 6 current clinical trials in our France, China, UK, USA, Spain, Italy, Belgium, Sweden, Poland, Canada, Israel, Taiwan, Germany, Brazil, Australia, Egypt, Netherlands, Denmark, Czechia, Turkey and Switzerland registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Acerta Pharma BV (1). The most-studied condition is Chronic Lymphocytic Leukemia.

Where Chlorambucil is approved

All regulators →

Of the three regulators tracked here, the first to approve Chlorambucil was the US, on 18 Mar 1957.

USUnited States (FDA)
18 Mar 1957
Leukeran
NDA010669 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
No new-drug Notice of Compliance since 1994
First new-drug NOC

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 Chlorambucil works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • B-cell chronic lymphocytic leukemiaPhase 3
  • MALT lymphomaPhase 3
  • Waldenstrom macroglobulinemiaPhase 3
  • Focal segmental glomerulosclerosisPhase 3
  • Follicular lymphomaPhase 3
  • Gastric lymphomaPhase 3
  • Lymphoplasmacytic lymphomaPhase 3
  • Membranous glomerulonephritisPhase 3
  • Non-Hodgkin lymphomaPhase 3
  • Splenic marginal zone lymphomaPhase 3
15 diseases in all

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL515, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 7143, 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 Chlorambucil

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 1 product on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-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 Chlorambucil

ATC code
L01AA02
ChEMBL
CHEMBL515
DrugBank
DB00291
PubChem CID
2708
CAS number
305-03-3
FDA UNII
18D0SL7309
Wikidata
Q415939
Wikipedia
Chlorambucil

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

  • Recruiting117%
  • Active, closed583%

Trials by phase

  • Phase 3583%
  • Phase 2117%
01

Clinical trials of Chlorambucil

6 trials
StudyPhaseStatusLead sponsorRegisters
A Study of Lisaftoclax (APG-2575) Combined With Acalabrutinib Versus Immunochemotherapy for Newly Diagnosed CLL/SLL.
NCT06319456 · ClinicalTrials.gov ↗ · CLL/SLL
Phase 3 Recruiting Ascentage Pharma Group Inc China
Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL
NCT02475681 · Chronic Lymphocytic Leukemia
Phase 3 Active, closed Acerta Pharma BV UK, USA, Germany, France, Spain, Italy, Belgium, Sweden, Poland, Canada, Brazil, Australia, Israel, Egypt
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
NCT03462719 · Leukemia, Lymphocytic, Chronic, B-Cell
Phase 3 Active, closed Janssen Research & Development, LLC UK, USA, France, Spain, Netherlands, Belgium, Sweden, Denmark, Poland, Czechia, Turkey, Canada, Israel
Study of Acalabrutinib Versus Chlorambucil Plus Rituximab in Adult Subjects With Previously Untreated Chronic Lymphocytic Leukemia
NCT04075292 · ClinicalTrials.gov ↗ · Untreated Chronic Lymphocytic Leukemia
Phase 3 Active, closed AstraZeneca China, Taiwan
A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors
NCT06970743 · Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Phase 3 Active, closed BeOne Medicines China, Taiwan
Phase II Study of Chlorambucil and Subcutaneous Rituximab in Patients With Extranodal MALT Lymphoma
NCT01808599 · ClinicalTrials.gov ↗ · MALT Lymphoma
Phase 2 Active, closed International Extranodal Lymphoma Study Group (IELSG) France, Italy, Switzerland

Registers 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.

02

Chlorambucil across our data

Ireland · EU · US

The 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 Chlorambucil on the HPRA medicines list.

All 1 Irish product →

Supply shortages

No entry for Chlorambucil in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Chlorambucil

6 conditions
Chronic Lymphocytic Leukemia2Leukemia, Lymphocytic, Chronic, B-Cell1Small Lymphocytic Lymphoma1CLL/SLL1Untreated Chronic Lymphocytic Leukemia1MALT Lymphoma1
06

Related compounds

07

Questions about Chlorambucil trials

How many clinical trials are testing Chlorambucil?

6 current trials in our France, China, UK, USA, Spain, Italy, Belgium, Sweden, Poland, Canada, Israel, Taiwan, Germany, Brazil, Australia, Egypt, Netherlands, Denmark, Czechia, Turkey and Switzerland registers name Chlorambucil as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.

Are Chlorambucil trials recruiting patients?

Yes. 1 of the 6 trials is recruiting: 1 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Chlorambucil clinical trials?

Acerta Pharma BV (1), Janssen Research & Development, LLC (1), BeOne Medicines (1) and Ascentage Pharma Group Inc (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.

Is Chlorambucil licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Chlorambucil, for example Leukeran 2 mg film-coated tablets (Aspen Pharma Trading Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Chlorambucil shortage?

Not in the lists we track: Chlorambucil 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 Chlorambucil works or whether it is effective, and it is not medical advice.

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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 Chlorambucil works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Chlorambucil (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.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.