Drug

Anastrozole

In clinical development

ClassCytochrome P450 19A1 inhibitorEmerging researchLate-stage developmentRising momentum

Also known as Arimidex, Anastrozol, anatrozole.

RxNorm84857 ChEMBLCHEMBL1399 ATCL02BG03UNII2Z07MYW1AZ

Research papers

Active clinical trials

Aromatase

Primary target

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter, Phase I/II Trial of Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in HR-positive, HER2-positive Metastatic Breast Cancer

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Clinical trial2026-07-30Results expected Q2 2029 · ClinicalTrials.gov

A Phase III Trial of Rx Therapy Guided by Genomic Risk Assessment for High Anatomic Stage ER-pos/HER2-neg Breast Cancer With RS≤25 (RxFINE-Low)

Clinical trial2026-07-10Results expected Q3 2029 · ClinicalTrials.gov

Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study

Clinical trial2026-07-08Results expected Q3 2029 · ClinicalTrials.gov

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors

Clinical trial2026-07-07Results expected Q3 2030 · ClinicalTrials.gov

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients With 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer With Recurrence Score (RS) of 25 or Less. RxPONDER: A Clinical Trial Rx for Positive Node, Endocrine Responsive Breast Cancer

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

The TRADE Study: A Phase 2 Trial to Assess the ToleRability of Abemaciclib Dose Escalation in Patients With Early-Stage HR-positive and HER2-negative Breast Cancer

Clinical trial2026-07-02Results posted · ClinicalTrials.gov

An Open Label Phase II Study of the Efficacy and Safety of Abemaciclib, a Cyclin Dependent Kinase (CDK4/6) Inhibitor in Selected Patients With Recurrent Ovarian or Endometrial Cancer

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

MC1633 Phase II Trial to Evaluate the Efficacy of the FASN Inhibitor, TVB-2640, in Combination With Trastuzumab Plus Paclitaxel or Endocrine Therapy in Patients With HER2+ Metastatic Breast Cancer Resistant to Trastuzumab-Based Therapy

Clinical trial2026-07-01Results posted · ClinicalTrials.gov

Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3.

Research2024-05-08Annals of oncology : official journal of the European Society for Medical Oncology

Anastrozole in Pulmonary Arterial Hypertension. A Randomized, Double-Blind, Placebo-controlled Trial.

Research2017-02-01American journal of respiratory and critical care medicine

The effects of neoadjuvant anastrozole (Arimidex) on tumor volume in postmenopausal women with breast cancer: a randomized, double-blind, single-center study.

Research2000-06-01Clinical cancer research : an official journal of the American Association for Cancer Research

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Anastrozole

Aliases & brands

ArimidexAnastrozolanatrozole

RxNorm CUI

84857

ChEMBL ID

CHEMBL1399

ATC codes

L02BG03

UNII

2Z07MYW1AZ

Primary mechanism

Cytochrome P450 19A1 inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Aromatase

CYP19A1 · P11511

INHIBITORCytochrome P450 19A1 inhibitor

Clinical trials

195 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

195

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

105

Completed

Discontinued

PHASE DISTRIBUTIONn = 195

Early Phase 11Phase 117Phase 1 / 26Phase 289Phase 2 / 31Phase 355Phase 410Phase N / A16

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Active, not recruitingPH IVNovartis Pharmaceuticalsn=1342030

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences (Phase 2)

CompletedPH IVUniversity of Wisconsin, Madisonn=222025

An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)

WithdrawnPH IVFred Hutchinson Cancer Center2025

PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant

TerminatedPH IVPalleos Healthcare GmbHn=5322021

Randomization to Letrozole vs. Anastrozole in Short Pubertal Males

CompletedPH IVStanford Universityn=792018

Recent completions

Trials that read out recently, adding to the completed evidence base.

CompletedPH IIMayo Clinicn=172026

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

CompletedPH IIIAstraZenecan=4622026

A Window-of-Opportunity Trial of Giredestrant +/- Triptorelin vs. Anastrozole + Triptorelin in Premenopausal Patients With ER-positive/HER2-negative Early Breast Cancer

CompletedPH IIETOP IBCSG Partners Foundationn=2312025

Human Cerebral Blood Flow Regulation: Sex, Mechanism, and Stress Differences (Phase 2)

CompletedPH IVUniversity of Wisconsin, Madisonn=222025

Neoadjuvant Endocrine Therapy in Hormone Receptor-Positive HER2-Negative Node-Negative Breast Cancer Patients to Assess Responses and Mechanisms of Endocrine Resistance

CompletedPH IIMedical College of Wisconsinn=372025

A Phase II, Multicenter, Randomized, Open-label Study to Evaluate the Safety and Efficacy of 400 mg of Ribociclib in Combination With Non-steroidal Aromatase Inhibitors for the Treatment of Pre- and Postmenopausal Women With Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Who Received no Prior Therapy for Advanced Disease

CompletedPH IINovartis Pharmaceuticalsn=3762024

Research activity

3 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20002024

Most influential

Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3.

Annals of oncology : official journal of the European Society for Medical Oncology · 2024 · 161 cites

The effects of neoadjuvant anastrozole (Arimidex) on tumor volume in postmenopausal women with breast cancer: a randomized, double-blind, single-center study.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2000 · 94 cites

Anastrozole in Pulmonary Arterial Hypertension. A Randomized, Double-Blind, Placebo-controlled Trial.

American journal of respiratory and critical care medicine · 2017 · 91 cites

Related drugs

2 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Letrozole

Acts on the same molecular target as Anastrozole, with an overlapping disease area.

Shared target1 shared disease1 shared paper

Abemaciclib

Studied across the same disease area as Anastrozole in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials