Ozmosi | Fulvestrant Drug Profile

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 Indications: None

Known Adverse Events: None

Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
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, 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: 94

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Breast Cancer|Breast Cyst

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

Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
GIM16-FEVEX - âFulvestrant and EVerolimus plus EXemestane in metastatic breast cancer	P3	Completed	Breast Cancer	2025-01-23		2025-07-09	Treatments
CAAA603B12101	P1	Recruiting	Breast Cancer	2026-12-30	23%	2024-07-19	Primary Endpoints
DISCUSS	P2	Recruiting	Breast Cancer	2028-05-15		2025-05-02	Treatments
Morpheus-panBC	P2	Recruiting	Breast Cancer	2028-05-03	12%	2024-08-28	Patient Enrollment\|Primary Completion Date\|Primary Endpoints\|Study Completion Date
STUDY00026643	P2	Recruiting	Pancreatic Cancer\|Prostate Cancer\|Sarcoma\|Breast Cancer\|Ovarian Cancer	2027-12-31	12%	2025-07-01
DARE	P2	Recruiting	Breast Cancer	2027-12-31	12%	2025-01-14
TRAK-ER	P2	Recruiting	Breast Cancer	2027-09-01	12%	2025-02-07	Primary Endpoints\|Treatments
LITESPARK-029	P2	Recruiting	Breast Cancer	2027-05-05	12%	2024-11-01	Primary Endpoints\|Start Date\|Treatments\|Trial Status
TQB3912-TQB3616-Ib/II-01	P2	Recruiting	Breast Cancer	2027-04-01	12%	2025-05-22	Primary Endpoints\|Start Date\|Trial Status
MATRIX	P2	Not yet recruiting	Breast Cancer	2027-04-01	36%	2024-03-30	Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date\|Treatments
NCT06110793	P2	Recruiting	Breast Cancer	2026-11-01	12%	2024-01-03	Primary Endpoints\|Start Date\|Trial Status
NCI-2021-09936	P2	Active, not recruiting	Endometrial Cancer\|Ovarian Cancer	2026-10-29	12%	2024-06-11	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
GBG 118	P2	Recruiting	Breast Cancer	2026-10-15	12%	2025-05-02	Treatments
WO41554	P3	Active, not recruiting	Breast Cancer	2030-09-30		2025-05-02	Treatments
INAVO121	P3	Active, not recruiting	Breast Cancer	2029-03-30	79%	2025-01-30	Primary Endpoints\|Treatments\|Trial Status
WO43919	P3	Active, not recruiting	Breast Cancer	2029-03-30	79%	2025-05-02	Treatments
jRCT2051230196	P3	Recruiting	Breast Cancer	2028-11-13
ReDiscover-2	P3	Not yet recruiting	Breast Cancer	2028-04-30	46%	2025-05-22	Primary Endpoints
CAPItello-292	P3	Recruiting	Breast Cancer	2028-04-21		2025-05-02	Treatments
CAPItana	P3	Recruiting	Breast Cancer	2027-12-31	41%	2025-04-10	Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date\|Treatments
CBYL719C2303	P3	Active, not recruiting	Breast Cancer	2027-12-29		2025-05-02	Treatments
CAPItello-292	P3	Recruiting	Breast Cancer	2027-11-01	78%	2024-02-15
CAPItrue	P3	Recruiting	Breast Cancer	2026-10-31	81%	2025-01-23	Primary Completion Date\|Primary Endpoints\|Study Completion Date\|Treatments
HB1901-009	P1	Not yet recruiting	Breast Cancer	2027-10-01	23%	2025-04-24	Primary Endpoints\|Treatments
LAE205INT3101	P3	Recruiting	Breast Cancer	2026-10-30	13%	2024-07-23	Primary Completion Date\|Primary Endpoints

Recent News Events

Date	Type	Title
06/30/2025	News Article	Celcuity Reports Clinical Data from Two Early Phase Studies of Gedatolisib
06/20/2025	News Article	With Public Funding Under Pressure, Biotech Innovators Are Picking Up the Slack in Oncology
06/11/2025	News Article	Global Billion Dollar Oncology Industry Experiencing Substantial Growth Driven by Increasing Cancer Incidences
06/06/2025	News Article	Arvinas Announces Submission of New Drug Application to U.S. FDA for Vepdegestrant for Patients with ESR1-Mutated ER+/HER2- Advanced or Metastatic Breast Cancer

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Fulvestrant

Alternative Names: fulvestrant, faslodex Clinical Status: Inactive Latest Update: 2025-07-04 Latest Update Note: Clinical Trial Update