Ozmosi | Fulvestrant Drug Profile
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Fulvestrant

Alternative Names: fulvestrant, faslodex
Clinical Status: Inactive
Latest Update: 2026-03-11
Latest Update Note: Clinical Trial Update

Product Description

Fulvestrant is a pure antiestrogen that emerged from a systematic medicinal chemistry strategy of modification of long-chain alkyl substitutes in the 7a-position of estradiol. Fulvestrant has no uterotrophic effects on the immature or ovariectomized rat and blocks the agonistic effects of estradiol and tamoxifen in a dose-dependent manner. In in vivo and in vitro breast cancer models, fulvestrant has anticancer activity at least as good as tamoxifen and is superior to tamoxifen in some models. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/15865849/)

Mechanisms of Action: ER Antagonist

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Intramuscular

FDA Designation: *

Approval Status: Approved

Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam

Approved Indications: None

Known Adverse Events: None

Company: AstraZeneca
Company Location: Europe
Company Founding Year: 1999
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Fulvestrant

Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam

Active Clinical Trial Count: 2

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Breast Cancer|Breast Cyst

Phase 2: Adenocarcinoma|Adenosarcoma|Breast Diseases|Endometrial Cancer|Endometrial Stromal Tumors|Fallopian Tube Cancer|Genital Cancer, Female|Male Breast Cancer|Melanoma|Mouth Cancer|NUT Carcinoma|Ovarian Cancer|Pancreatic Cancer|Pelvic Cancer|Peritoneal Cancer|Pregnancy Outcomes|Pregnancy, Ovarian|Prostate Cancer|Sarcoma|Sarcoma, Endometrial Stromal|Skin Cancer|Tic Disorders|Triple Negative Breast Cancer|Uterine Cancer

Phase 1: Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Small Cell Lung Cancer

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2023-503629-20-00

CO40115

P2

Recruiting

Triple Negative Breast Cancer

2026-07-26

12%

2025-05-02

Treatments

NCT04544189

CBYL719C2201

P2

Active, not recruiting

Breast Cancer

2026-03-02

12%

2025-05-16

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

2017-005018-76

FUlvestrant in gynecological Cancers that are potentially Hormone Sensitive: the FUCHSia study

P2

Active, not recruiting

Endometrial Cancer|Sarcoma, Endometrial Stromal|Ovarian Cancer|Adenosarcoma|Endometrial Stromal Tumors|Uterine Cancer

2026-01-14

2022-03-13

Treatments

2023-506771-10-00

I3Y-MC-JPEF

P3

Active, not recruiting

Breast Cyst

2026-02-16

22%

2025-05-02

NCT05392608

SEQUEL-Breast

P2

Active, not recruiting

Tic Disorders|Breast Cancer|Breast Diseases

2026-01-01

2025-09-18

2013-001269-18

DETECT - IV

P2

Completed

Triple Negative Breast Cancer|Male Breast Cancer

2023-06-17

2022-03-13

Treatments

NCT06630325

STUDY00026643

P2

Active, not recruiting

Ovarian Cancer|Breast Cancer|Sarcoma|Pancreatic Cancer|Prostate Cancer

2027-12-31

12%

2026-01-08

NCT03531645

NCI-2018-00941

P2

Active, not recruiting

Genital Cancer, Female|Ovarian Cancer|Skin Cancer|Peritoneal Cancer|Pregnancy Outcomes|Pregnancy, Ovarian|Pelvic Cancer|NUT Carcinoma|Fallopian Tube Cancer|Mouth Cancer

2027-09-30

50%

2025-09-10

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT05113368

CASE2820

P2

Recruiting

Ovarian Cancer

2026-09-01

12%

2025-08-22

Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments

NCT03643510

NCT03643510

P2

Active, not recruiting

Adenocarcinoma

2026-08-01

12%

2024-01-23

Patient Enrollment|Primary Endpoints|Treatments|Trial Status

NCT07340619

EPIBREAST

P2

Not yet recruiting

Melanoma

2028-11-18

12%

2026-01-15

Primary Endpoints|Treatments

jRCT2051230196

jRCT2051230196

P3

Recruiting

Breast Cancer

2028-11-13

NCT07393321

NTQ1062-301

P3

Not yet recruiting

Breast Cancer

2028-08-31

10%

2026-02-10

Primary Endpoints|Treatments

2025-523083-21-00

RLY-2608-102

P3

Not yet recruiting

Breast Cancer

2028-07-01

NCT06982521

ReDiscover-2

P3

Recruiting

Breast Cancer

2028-04-30

13%

2025-07-24

Primary Endpoints|Treatments|Trial Status

NCT03424005

Morpheus-panBC

P2

Recruiting

Breast Cancer

2030-09-30

12%

2025-11-29

NCT07405801

CO46274

P2

Recruiting

Breast Cancer

2028-12-19

12%

2026-03-10

Primary Endpoints

NCT07389733

HRS-6208-201-BC

P2

Not yet recruiting

Breast Cancer

2028-12-01

12%

2026-02-06

Primary Endpoints|Treatments

NCT07368998

optINAVO

P2

Recruiting

Breast Cancer

2028-10-31

12%

2026-02-24

Primary Endpoints|Treatments|Trial Status

2025-522805-39-00

WO46063

P2

Not yet recruiting

Breast Cancer

2028-07-01

12%

2023-504141-31-00

DISCUSS

P2

Recruiting

Breast Cancer

2028-05-15

2025-05-02

Treatments

NCT05154487

GOG-3069

P2

Active, not recruiting

Endometrial Cancer

2028-05-01

12%

2026-03-04

Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status

2023-505812-39-00

WO41554

P3

Active, not recruiting

Breast Cancer

2030-09-30

2025-05-02

Treatments

NCT07207070

JS105-004-III-BC

P3

Recruiting

Breast Cancer

2029-05-31

11%

2025-12-31

Primary Endpoints|Start Date|Treatments|Trial Status

2022-502322-41-00

WO43919

P3

Active, not recruiting

Breast Cancer

2029-03-30

49%

2025-05-02

Treatments