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 CEO: Pascal Soriot
Additional Commercial Interests: None
Clinical Description
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: 96
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 |
|---|---|---|---|---|---|---|---|---|
NCT05392608 |
SEQUEL-Breast | P2 |
Active, not recruiting |
Breast Cancer|Tic Disorders|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 |
|
NCT07340619 |
EPIBREAST | P2 |
Not yet recruiting |
Melanoma |
2028-11-18 |
12% |
2026-01-15 |
Primary Endpoints|Treatments |
NCT06630325 |
STUDY00026643 | P2 |
Active, not recruiting |
Sarcoma|Pancreatic Cancer|Prostate Cancer|Breast Cancer|Ovarian Cancer |
2027-12-31 |
12% |
2026-01-08 |
|
NCT03531645 |
NCI-2018-00941 | P2 |
Active, not recruiting |
Pelvic Cancer|Skin Cancer|Pregnancy Outcomes|Peritoneal Cancer|NUT Carcinoma|Ovarian Cancer|Fallopian Tube Cancer|Mouth Cancer|Pregnancy, Ovarian|Genital Cancer, Female |
2027-09-30 |
12% |
2025-09-10 |
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 |
2023-506771-10-00 |
I3Y-MC-JPEF | P3 |
Active, not recruiting |
Breast Cyst |
2026-02-16 |
14% |
2025-05-02 |
|
2023-503629-20-00 |
CO40115 | P2 |
Recruiting |
Triple Negative Breast Cancer |
2026-07-26 |
12% |
2025-05-02 |
Treatments |
2017-005018-76 |
FUlvestrant in gynecological Cancers that are potentially Hormone Sensitive: the FUCHSia study | P2 |
Active, not recruiting |
Sarcoma, Endometrial Stromal|Ovarian Cancer|Uterine Cancer|Endometrial Cancer|Endometrial Stromal Tumors|Adenosarcoma |
2026-01-14 |
2022-03-13 |
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 |
12% |
2025-07-24 |
Primary Endpoints|Treatments|Trial Status |
2023-504997-39-00 |
CAPItello-292 | P3 |
Recruiting |
Breast Cancer |
2028-04-21 |
2025-05-02 |
Treatments |
|
NCT06764186 |
CAPItana | P3 |
Active, not recruiting |
Breast Cancer |
2027-12-31 |
27% |
2026-01-14 |
Patient Enrollment|Primary Endpoints|Treatments|Trial Status |
2023-509133-39-00 |
CBYL719C2303 | P3 |
Active, not recruiting |
Breast Cancer |
2027-12-29 |
2025-05-02 |
Treatments |
|
NCT04862663 |
CAPItello-292 | P3 |
Recruiting |
Breast Cancer |
2027-11-01 |
74% |
2024-02-15 |
|
NCT06941142 |
HB1901-009 | P1 |
Not yet recruiting |
Breast Cancer |
2027-10-01 |
12% |
2025-04-24 |
Primary Endpoints|Treatments |
NCT07062965 |
C4551002 | P3 |
Recruiting |
Breast Cancer |
2027-07-22 |
19% |
2025-08-16 |
|
NCT03424005 |
Morpheus-panBC | P2 |
Recruiting |
Breast Cancer |
2030-09-30 |
12% |
2025-11-29 |
|
2023-504141-31-00 |
DISCUSS | P2 |
Recruiting |
Breast Cancer |
2028-05-15 |
2025-05-02 |
Treatments |
|
NCT04567420 |
DARE | P2 |
Recruiting |
Breast Cancer |
2027-12-31 |
12% |
2025-01-14 |
|
NCT04985266 |
TRAK-ER | P2 |
Recruiting |
Breast Cancer |
2027-09-01 |
12% |
2025-02-07 |
Primary Endpoints|Treatments |
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 |
45% |
2025-05-02 |
Treatments |
jRCT2051230196 |
jRCT2051230196 | P3 |
Recruiting |
Breast Cancer |
2028-11-13 |