Anastrozole clinical trials
Anastrozole is named as an intervention in 43 current clinical trials in our France, Mexico, Italy, USA, Spain, Canada, Israel, South Korea, Germany, Belgium, China, Taiwan, Australia, Brazil, Portugal, UK, Turkey, Japan, Poland, Netherlands, India, Austria, Ireland, Czechia, Switzerland, Singapore, Sweden, Denmark and Norway registers. 14 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Eli Lilly and Company (7). The most-studied condition is Breast Cancer. The EU clinical trials register (CTIS) separately lists 3 authorised or ongoing trials.
Where Anastrozole is approved
All regulators →Of the three regulators tracked here, the first to approve Anastrozole was the US, on 27 Dec 1995. It is approved in 2 of the 3 regulators tracked here.
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 Anastrozole
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 Anastrozole works
All drug targets →- Cytochrome P450 19A1 inhibitor InhibitorTarget: CYP19A1 cytochrome P450 family 19 subfamily A member 1✓ In ChEMBL and the Guide to Pharmacology
- GynecomastiaPhase 3
- InfertilityPhase 3
- Klinefelter syndromePhase 3
- Ductal breast carcinoma in situPhase 3
- Insulin resistancePhase 2
- Bone metastasisPhase 2
- CancerPhase 2
- Cardiovascular disorderPhase 2
- Endometrial cancerPhase 2
- Endometrial carcinomaPhase 2
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1399, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5137, 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 Anastrozole
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Anastrozole. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Hormonal therapies for the adjuvant treatment of early oestrogen-receptor-positive breast cancer NICE TA112 | Recommended | 22 Nov 2006 | 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 Anastrozole
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.
- 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 Anastrozole
- ATC code
- L02BG03
- ChEMBL
- CHEMBL1399
- DrugBank
- DB01217
- PubChem CID
- 2187
- CAS number
- 120511-73-1
- FDA UNII
- 2Z07MYW1AZ
- Wikidata
- Q419143
- Wikipedia
- Anastrozole
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 Anastrozole
43 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.
Anastrozole in the EU trials register (CTIS)
3 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Anastrozole. 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 |
|---|---|---|---|---|
|
Optimization of De-EscalatiON strategies in early breast cancer
2026-527524-27-00 · Neoplasms
|
Phase 2 | Authorised | Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS | Italy |
|
Radium223 dichloride (223RaCl) in the treatment of symptomatic bone metastases from breast cancer.
2025-524208-31-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone | Italy |
|
NoELA_No Endocrine therapy in small HR+ HER2- low relapse risk Luminal A early breast cancer, a single-arm de-escalation trial
2025-523683-20-00 · CTIS ↗ · Neoplasms
|
Phase 2 | Authorised | Unicancer | France |
Anastrozole 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 Anastrozole on the HPRA medicines list.
- Agerdex 1 mg film-coated tabletsViatris Limited · PA23266/075/001 · Marketed
- Amidex 1 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/189/001 · Marketed
- Anastrozole 1 mg film-coated tabletsAccord Healthcare Ireland Ltd. · PA2315/076/001 · Marketed
- Anastrozole Teva 1 mg film-coated tabletsTeva Pharma B.V. · PA0749/028/001 · Marketed
- Arimidex 1 mg film-coated tabletsLaboratoires Juvise Pharmaceuticals · PA23154/001/001 · Marketed
Supply shortages
No entry for Anastrozole in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Anastrozole
51 conditionsAll 51 conditions
| Condition (as registered) | Trials |
|---|---|
| Breast Cancer | 16 |
| HER2-negative Breast Cancer | 4 |
| Breast Neoplasms | 4 |
| Metastatic Breast Cancer | 4 |
| Breast Cancer, Early Breast Cancer | 2 |
| ER-Positive HER2-Negative Breast Cancer | 2 |
| Advanced Breast Cancer | 2 |
| Breast Ductal Carcinoma In Situ | 1 |
| Invasive Breast Carcinoma | 1 |
| Multicentric Breast Carcinoma | 1 |
| Multifocal Breast Carcinoma | 1 |
| ER-positive Breast Cancer | 1 |
| Stage IIB Breast Cancer | 1 |
| Stage III Breast Cancer | 1 |
| Neoplasm Metastasis | 1 |
| Low Grade Serous Ovarian Cancer | 1 |
| Solid Tumors, Adult | 1 |
| Breast Adenocarcinoma | 1 |
| Hormone Receptor Positive | 1 |
| Stage IA Breast Cancer AJCC v7 | 1 |
| Stage IB Breast Cancer AJCC v7 | 1 |
| ER Positive Breast Cancer | 1 |
| Non Small Cell Lung Cancer | 1 |
| HR+/HER2- Advanced/Metastatic Breast Cancer | 1 |
| Locally Advanced Breast Cancer | 1 |
| HER-2 Positive Breast Cancer | 1 |
| Estrogen Receptor Positive Breast Cancer | 1 |
| Cancer Metastatic | 1 |
| ER+ Breast Cancer | 1 |
| Breast Neoplasm Female | 1 |
| Klinefelter Syndrome | 1 |
| Cerebral Blood Flow | 1 |
| Cerebral Blood Flow Regulation | 1 |
| Sex Differences | 1 |
| Exercise | 1 |
| Anatomic Stage II Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | 1 |
| Anatomic Stage IIIC Breast Cancer AJCC v8 | 1 |
| Estrogen Receptor-Positive Breast Carcinoma | 1 |
| Locoregional Recurrence | 1 |
| Hormone Receptor-positive Breast Cancer | 1 |
| Estrogen Receptor-positive Breast Cancer | 1 |
| Invasive Ductal Breast Carcinoma | 1 |
| Invasive Lobular Breast Carcinoma | 1 |
| Breast Diseases | 1 |
| Early-stage Breast Cancer | 1 |
| High Risk Breast Carcinoma | 1 |
| HER2-positive Breast Cancer | 1 |
| Invasive Carcinoma of the Breast | 1 |
| Node Negative Breast Cancer | 1 |
| Low Grade Endometrial Stromal Sarcoma | 1 |
Sponsors
lead sponsor per trial+ 12 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 Anastrozole trials
How many clinical trials are testing Anastrozole?
43 current trials in our France, Mexico, Italy, USA, Spain, Canada, Israel, South Korea, Germany, Belgium, China, Taiwan, Australia, Brazil, Portugal, UK, Turkey, Japan, Poland, Netherlands, India, Austria, Ireland, Czechia, Switzerland, Singapore, Sweden, Denmark and Norway registers name Anastrozole (also registered as ICI D1033) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Anastrozole trials recruiting patients?
Yes. 14 of the 43 trials are recruiting: 8 with sites in France, 3 with sites in Mexico, 6 with sites in Italy, 5 with sites in USA, 6 with sites in Spain, 4 with sites in Canada, 3 with sites in Israel, 4 with sites in South Korea, 6 with sites in Germany, 5 with sites in Belgium, 6 with sites in China, 3 with sites in Taiwan, 4 with sites in Australia, 3 with sites in Brazil, 3 with sites in Portugal, 4 with sites in UK, 3 with sites in Turkey, 5 with sites in Japan, 3 with sites in Poland, 4 with sites in Netherlands, 2 with sites in India, 2 with sites in Austria, 4 with sites in Ireland, 2 with sites in Czechia, 2 with sites in Switzerland, 2 with sites in Singapore, 1 with sites in Sweden and 1 with sites in Denmark. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Anastrozole clinical trials?
Eli Lilly and Company (7), AstraZeneca (6), National Cancer Institute (NCI) (3) and Tolmar Inc (2), among 27 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Anastrozole clinical trials in Ireland?
Yes. 8 trials 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 Anastrozole licensed in Ireland?
Yes. The HPRA medicines list includes 10 single-substance products containing Anastrozole, for example Agerdex 1 mg film-coated tablets (Viatris Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Anastrozole shortage?
Not in the lists we track: Anastrozole 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 Anastrozole 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 Anastrozole 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 Anastrozole (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.