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anastrozole

Trade name: arimidex

Small moleculeapproved

Approved

Dec 27, 1995

Anastrozole (marketed under the trade name Arimidex by AstraZeneca) is a drug indicated in the treatment of breast cancer in post-menopausal women. It is used both in adjuvant therapy (i.e. following surgery) and in metastatic breast cancer. It decreases the amount of estrogens that the body makes. Anastrozole belongs in the class of drugs known as aromatase inhibitors. It inhibits the enzyme aromatase, which is responsible for converting androgens (produced by women in the adrenal glands) to estrogens. The growth of many cancers of the breast is stimulated or maintained by estrogens. In postmenopausal women, estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens (primarily androstenedione and testosterone) to estrone and estradiol. The suppression of estrogen biosynthesis in peripheral tissues and in the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme. Anastrozole is a selective non-steroidal aromatase inhibitor. It significantly lowers serum estradiol concentrations and has no detectable effect on formation of adrenal corticosteroids or aldosterone. — NCATS

Clinical trial activity

307 trials · 285 clinical orgs · 27 marketing orgs

Phase 1
39
Phase 2
230
Phase 3
93
Phase 4
20

Earliest trial started Jan 1, 1996 (NCT00300508)

Timeline

1990s

  1. Dec 27, 1995

    AstraZeneca — Earliest FDA Approval

  2. Dec 27, 1995

    AstraZeneca — NDA Organization

  3. Dec 27, 1995

    Ani Pharmaceuticals — NDA Secondary Org

  4. Dec 27, 1995

    Ani Pharmaceuticals — Marketing Organization

  5. Jan 1, 1996

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 1996

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2004

    Earliest Phase 1 Sponsor(trial)

  2. May 25, 2007

    Byondis — Marketing Organization

  3. Dec 5, 2008

    AstraZeneca — NDA Secondary Org

2010s

  1. Jun 28, 2010

    Kenton — Marketing Organization

  2. Jun 28, 2010

    Hikma — Marketing Organization

  3. Jun 28, 2010

    Accord Research — Marketing Organization

  4. Jun 28, 2010

    Boscogen — Marketing Organization

  5. Jun 28, 2010

    Cipla — Marketing Organization

  6. Jun 28, 2010

    Fresenius — Marketing Organization

  7. Jun 28, 2010

    Sandoz — Marketing Organization

  8. Jun 28, 2010

    Teva — Marketing Organization

  9. Jun 28, 2010

    West-Ward Pharmaceutical — Marketing Organization

  10. Jun 28, 2010

    Zydus Discovery DMCC — Marketing Organization

  11. Jun 28, 2010

    US Antibiotics — Marketing Organization

  12. Jun 28, 2010

    Picket Pharms — Marketing Organization

  13. Jun 28, 2010

    Mylan — Marketing Organization

  14. Jun 28, 2010

    Natco Pharma — Marketing Organization

  15. Jun 28, 2010

    Neopharma — Marketing Organization

  16. Jun 28, 2010

    Novartis — Marketing Organization

  17. Jun 28, 2010

    PHARMOBEDIENT — Marketing Organization

  18. Jan 5, 2011

    Chartwell Pharmaceuticals — Marketing Organization

  19. Jan 5, 2011

    Lannett Company, Inc. — Marketing Organization

  20. Jul 15, 2011

    Sun Pharmaceuticals — Marketing Organization

  21. May 11, 2012

    Apotex — Marketing Organization

  22. May 31, 2012

    Impax Laboratories — Marketing Organization

  23. Nov 9, 2018

    Yiling Pharmaceutical Inc. — Marketing Organization

2020s

  1. Jul 24, 2020

    Eugia Pharma — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedDec 27, 1995

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N
Mol. weight
293.3663 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • 1,3-benzenediacetonitrile, alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-
  • 2,2'-(5-(1h-1,2,4-triazol-1-ylmethyl)-1,3-phenylene)bis(2-methylpropionitrile)
  • alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile
  • alpha,alpha,alpha',alpha'-tetramethyl-5-(1h-1,2,4-triazol-1-ylmethyl)-m-benzenediacetonitrile
  • anastrazole
  • anastrazole
  • anastrol
  • anastrozol
  • anastrozol
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • anastrozole
  • arimidex
  • arimidex
  • arimidex
  • arimidex
  • arimidex
  • arimidex
  • armidexan
  • astra brand of anastrozole
  • astrazeneca brand of anastrozole
  • cosmofer
  • cosmofer
  • dexferrum
  • dexferrum
  • ferran 100
  • ici d1033
  • ici d1033
  • ici-d1033
  • ici-d1033
  • imferon
  • imferon
  • infed
  • infed
  • nastrosa
  • zd1033
  • zd-1033
  • zd-1033
  • zd-1033
  • zd-1033
  • zeneca brand of anastrozole
  • zeneca zd 1033

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07212712N/AMar 1, 2026University of British Columbia
NCT07163481Phase 1Oct 31, 2025Central South University, Gilead Sciences
NCT07174336Phase 3Oct 27, 2025Eli Lilly, Pfizer
NCT07101159Phase 2Sep 30, 2025Fujian Medical University
NCT07179939Phase 2Sep 10, 2025Fudan University, Hengrui Therapeutics, Inc., People's Liberation Army of China
NCT06953882Phase 2Jul 9, 2025Breast Cancer Research Foundation, Novartis, Yale University
NCT07061717Phase 3Jul 1, 2025Sun Yat-Sen University
NCT07019363Phase 3Jun 15, 2025Fudan University
NCT07190443Phase 3Feb 7, 2025Japan Clinical Oncology Group, Japanese Foundation for Cancer Research
NCT06671912Phase 3Nov 15, 2024National Cancer Institute (NCI)
NCT06699472Phase 2Oct 31, 2024Fudan University
NCT06492616Phase 3Sep 27, 2024Pipeline Therapeutics, Inc.
NCT06380751Phase 3Aug 1, 2024AstraZeneca
NCT06507618Phase 3Jul 19, 2024University of Virginia
NCT06569459Phase 2Jul 9, 2024Nanjing Medical University
NCT06179303Phase 2Jun 1, 2024Breast Cancer Research Foundation, University of Washington
NCT06223698Phase 3May 2, 2024Orebro University
NCT06001762Phase 2Feb 29, 2024Eli Lilly, Harvard University
NCT06957379Phase 2Feb 29, 2024Shijiazhuang Pharma Group (CSPC)
NCT06235931N/AFeb 1, 2024Soochow University
Showing 20 of 307 trials
Page 1 / 16

Organizations

Research & Development (285)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit634051996
National Cancer Institute (NCI)Government311051999
NovartisFor profit18931999
Eli LillyFor profit141042008
PfizerFor profit13142001
Harvard UniversityAcademic/Hospital12942001
Washington University in St. LouisAcademic/Hospital11532003
Fudan UniversityAcademic/Hospital9922008
University of LondonAcademic/Hospital9721998
Mayo ClinicAcademic/Hospital8532003
Southwest Oncology GroupAcademic/Hospital8422003
GenentechFor profit6022001
University of WashingtonAcademic/Hospital6532005
Hengrui Therapeutics, Inc.For profit5222018
RocheFor profit5222001
Stanford UniversityAcademic/Hospital5332000
Baylor UniversityAcademic/Hospital4422003
National Institutes of Health (NIH)Government4122000
Royal Marsden Hospital NHS TrustAcademic/Hospital4122004
UNICANCERAcademic/Hospital4322002
285 organizations
Page 1 / 15

Marketing (32)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGJun 28, 2010
Ani PharmaceuticalsFor profitNDA2Dec 27, 1995
Ani PharmaceuticalsFor profitMKTGDec 27, 1995
ApotexFor profitMKTGMay 11, 2012
AstraZenecaFor profitNDADec 27, 1995
AstraZenecaFor profitNDA2Dec 5, 2008
BoscogenFor profitMKTGJun 28, 2010
ByondisFor profitMKTGMay 25, 2007
Chartwell PharmaceuticalsFor profitMKTGJan 5, 2011
Chartwell PharmaceuticalsFor profitSYNJun 28, 2010
CiplaFor profitMKTGJun 28, 2010
Eugia PharmaFor profitMKTGJul 24, 2020
FreseniusFor profitMKTGJun 28, 2010
HikmaFor profitMKTGJun 28, 2010
HikmaFor profitSYNJun 28, 2010
Impax LaboratoriesFor profitMKTGMay 31, 2012
KentonFor profitMKTGJun 28, 2010
Lannett Company, Inc.For profitMKTGJan 5, 2011
MylanFor profitMKTGJun 28, 2010
Natco PharmaFor profitMKTGJun 28, 2010
NeopharmaFor profitMKTGJun 28, 2010
NovartisFor profitMKTGJun 28, 2010
PHARMOBEDIENTFor profitMKTGJun 28, 2010
Picket PharmsFor profitMKTGJun 28, 2010
SandozFor profitMKTGJun 28, 2010
Sun PharmaceuticalsFor profitMKTGJul 15, 2011
TevaFor profitMKTGJun 28, 2010
TevaFor profitSYNJun 28, 2010
US AntibioticsFor profitMKTGJun 28, 2010
West-Ward PharmaceuticalFor profitMKTGJun 28, 2010
Yiling Pharmaceutical Inc.For profitMKTGNov 9, 2018
Zydus Discovery DMCCFor profitMKTGJun 28, 2010